US20130011377A1 - Compositions, kits and methods for nutrition supplementation - Google Patents

Compositions, kits and methods for nutrition supplementation Download PDF

Info

Publication number
US20130011377A1
US20130011377A1 US13/475,182 US201213475182A US2013011377A1 US 20130011377 A1 US20130011377 A1 US 20130011377A1 US 201213475182 A US201213475182 A US 201213475182A US 2013011377 A1 US2013011377 A1 US 2013011377A1
Authority
US
United States
Prior art keywords
vitamin
amount
present
composition
magnesium
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Abandoned
Application number
US13/475,182
Inventor
Philippe Perrin
Guillaume Herry
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Chemo France SA
Original Assignee
Chemo France SA
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=46061241&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=US20130011377(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Chemo France SA filed Critical Chemo France SA
Priority to US13/475,182 priority Critical patent/US20130011377A1/en
Publication of US20130011377A1 publication Critical patent/US20130011377A1/en
Assigned to Chemo S.A. France reassignment Chemo S.A. France ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: PERRIN, PHILIPPE, HERRY, GUILLAUME
Priority to US15/343,599 priority patent/US20170112178A1/en
Priority to US17/534,817 priority patent/US20220079201A1/en
Priority to US17/750,969 priority patent/US20220279831A1/en
Abandoned legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/16Inorganic salts, minerals or trace elements
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/115Fatty acids or derivatives thereof; Fats or oils
    • A23L33/12Fatty acids or derivatives thereof
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/15Vitamins
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/15Vitamins
    • A23L33/155Vitamins A or D
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/40Complete food formulations for specific consumer groups or specific purposes, e.g. infant formula
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/01Hydrocarbons
    • A61K31/015Hydrocarbons carbocyclic
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/20Carboxylic acids, e.g. valproic acid having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids
    • A61K31/202Carboxylic acids, e.g. valproic acid having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids having three or more double bonds, e.g. linolenic
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/335Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/35Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
    • A61K31/352Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline 
    • A61K31/3533,4-Dihydrobenzopyrans, e.g. chroman, catechin
    • A61K31/355Tocopherols, e.g. vitamin E
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/335Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/365Lactones
    • A61K31/375Ascorbic acid, i.e. vitamin C; Salts thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4415Pyridoxine, i.e. Vitamin B6
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/455Nicotinic acids, e.g. niacin; Derivatives thereof, e.g. esters, amides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/506Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim not condensed and containing further heterocyclic rings
    • A61K31/51Thiamines, e.g. vitamin B1
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A61K31/525Isoalloxazines, e.g. riboflavins, vitamin B2
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/59Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems
    • A61K31/5939,10-Secocholestane derivatives, e.g. cholecalciferol, i.e. vitamin D3
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7135Compounds containing heavy metals
    • A61K31/714Cobalamins, e.g. cyanocobalamin, i.e. vitamin B12
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/06Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
    • A61K33/08Oxides; Hydroxides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/18Iodine; Compounds thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/24Heavy metals; Compounds thereof
    • A61K33/26Iron; Compounds thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/24Heavy metals; Compounds thereof
    • A61K33/30Zinc; Compounds thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/24Heavy metals; Compounds thereof
    • A61K33/34Copper; Compounds thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/02Algae
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/02Nutrients, e.g. vitamins, minerals
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23VINDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2002/00Food compositions, function of food ingredients or processes for food or foodstuffs

Definitions

  • the present invention relates to various vitamin, nutrient and mineral compositions and kits for nutritional supplementation and methods of administration of compositions and kits for nutritional supplementation in, for example, subjects in physiologically stressful states, such as occur during pregnancy, lactation, or in need thereof.
  • Nutritional supplementation serves a vital role in maintaining good health.
  • Nutritional supplementation is especially pertinent to women contemplating conceiving a child because optimizing specific nutrients before, during, and after the physiological processes of pregnancy or lactation can have profound, positive, and comprehensive impacts upon the overall wellness of the developing and newborn child as well as on the safety and health of the mother.
  • the present invention provides compositions, kits and methods designed to supplement the nutritional needs of individuals in physiologically stressful states.
  • vitamins and minerals serves a role in protecting against disease and contributes to the overall health of the mother and developing child.
  • vitamins, nutrients and minerals such as vitamin D, iodine, vitamin B1, vitamin B6, vitamin B12, vitamin B2, vitamin B9, vitamin B3, vitamin E, vitamin A, vitamin C, iron, zinc, copper, magnesium, and omega 3 fatty acids such as docosahexaenoic acid (DHA), play integral roles in physiological mechanisms that serve to prevent, treat and/or alleviate the occurrence or negative effects of some diseases.
  • DHA docosahexaenoic acid
  • Iodine also provides nutritional benefits as it is an essential component of the thyroid hormones that are involved in the regulation of various enzymes and metabolic processes, such as thyroxine and triiodothyronine.
  • iodine deficiency disorders include mental retardation, hypothyroidism, goiter, cretinism, and varying degrees of other growth and developmental abnormalities which can be a result from inadequate thyroid hormone production from lack of sufficient iodine.
  • iodine is an important element in breast milk for infant nutrition. An adequate concentration of iodine in breast milk is essential to provide for optimal neonatal thyroid hormone stores and to prevent impaired neurological development in breast-fed neonates.
  • vitamin D has more positive physiological effects than previous thought, in for example prenatal and pregnant women. It has recently been determined that vitamin D has previously unknown roles in the enhancement of vascular function, defense against cancer, immuno-competence, blood pressure regulation and possessing the ability to enhance cellular insulin sensitivity in the human body. Due to the additional roles that vitamin D plays in the human body, it has recently been determined that higher daily vitamin D intake beyond current recommendations may be associated with better health outcomes. Indeed, studies suggest increasing the serum level of 25-hydroxyvitamin D, a beneficial derivative of vitamin D, to a 30 ng/ml serum range.
  • a 30 ng/ml appears to be the most advantageous serum level in recent studies reviewing patient bone mineral density (BMD), lower extremity function, dental health, risk of falls, admission to nursing home, fractures, cancer prevention and incident hypertension. Bischoff-Ferrari H A, A DV E XP M ED B IOL. 624:55-71 (2008). Effective and safe doses of vitamin D to bring serum levels of 25-hydroxyvitamin D up to a desirable level of 30 ng/ml is currently needed.
  • a present problem with nutritional supplements that include multiple vitamins, nutrients and minerals is the ability to include all the components in one composition.
  • Providing a single composition multivitamin and multinutrient supplement is an appealing feature because it improves patient compliance. Patients, and specifically for example, pregnant patients, often have nausea, and may have difficulty swallowing nutritional supplements. Compliance issues regarding taking multiple pills may therefore result.
  • a one pill or one composition nutritional supplement that includes the beneficial vitamins, nutrients and minerals in appropriate dosage amongst would thus be beneficial for improving patient compliance in for example, pregnant women.
  • a difficulty in the nutrition supplement market is the ability to include multiple vitamins, minerals and nutrients of various water or fat solubilities in the needed dosage amounts all in one composition.
  • nutritional supplements that include fat soluble compounds such as DHA and water soluble vitamins such as B-complex vitamins and vitamin C, are often separated into multiple compositions.
  • a supplement comprising multiple vitamins, nutrients and minerals blended to form a single composition, is thus currently needed.
  • the single composition may be in the form of a gelcap.
  • Patient compliance is also improved if a gelcap is used to administer the drug because of its soft and elastic nature, which makes it easier to swallow compared to a hard tablet or caplet.
  • a liquid gelcap also has numerous advantages. First, it retains many of the advantages of consumer acceptance and is easier to swallow due to the outer coating being a soft and elastic gelatin shell. Also, concentrated liquid compositions are well suited for encapsulation within a soft gelatin shell, creating flexibility that further assists in the capsule being easier to swallow.
  • the active drug contained in the liquid form also provides advantages by dispersing the drug to the active site. For example, the active drug does not first have to dissolve in the gastrointestinal tract, thereby facilitating absorption of the pharmacologically active substance. See, for example, U.S. Pat. No. 6,689,382, which is expressly incorporated by reference herein.
  • the present invention provides compositions and methods of administering compositions for both prophylactic and therapeutic nutritional supplementation.
  • the present invention relates to novel compositions of vitamins, minerals, and omega-3 fatty acids that can be used to supplement the nutritional deficiencies observed in patients throughout physiologically stressful states, which, in certain embodiments of the present invention, include prenatal, pregnant and breast-feeding women.
  • One embodiment of the present invention may include a nutritional supplement wherein multiple vitamins, minerals and nutrients are provided in one composition.
  • the composition may comprise vitamin D, iodine, vitamin B1, vitamin B6, vitamin B12, vitamin B2, vitamin B9, vitamin B3, vitamin E, vitamin A, vitamin C, iron, zinc, copper, magnesium, omega 3 fatty acids and one or more pharmaceutically acceptable carriers.
  • vitamin D may be included in the form selected from one or more of the group consisting of vitamin D3 (calciol or cholecalciferol or colecalciferol), vitamin D2 (calciferol, ergocalciol, ergocalciferol, ercalciol, Deltalin or Viosterol), previtamin D2, ergosterol, calcitriol (1,25-dihydroxycholecalciferol), 7-dehydrocholesterol, vitamin D1, vitamin D4 (also known as 22-dihydroergocalciferol, 22,23-dihydroercalciol or (24S)-methylcalciol), vitamin D5 (also known as (24S)-Ethylcalciol or sitocalciferol), 7-dehydrositosterol, Lumisterol, 25-hydroxyvitamin D, all steroids that exhibit the biological activity of calciol, 25-fluorocalciol, (3S)
  • compositions may include vitamin B1 in the form selected from one or more of the group consisting of thiamine, thiamine monophosphate, thiamine diphosphate, thiamine triphosphate, acetiamine, allithiamine, prosultiamine and S-acyl derivatives of thiamine such as benfotiamine, fursultiamine and salts and esters thereof.
  • compositions may include vitamin B1 in the form selected from one or more of the group consisting of thiamine, thiamine monophosphate, thiamine diphosphate, thiamine triphosphate, acetiamine, allithiamine, prosultiamine and S-acyl derivatives of thiamine such as benfotiamine, fursultiamine and salts and esters thereof.
  • compositions may include vitamin A in the form selected from one or more of the group consisting of retinol acetate (retinyl acetate or vitamin A acetate), retinol (vitamin A alcohol), retinol palmitate (retinyl palmitate or vitamin A palmitate), retinoic acid (tretinoin), retinal, beta-cryptoxanthin, alpha-carotene, beta-carotene, gamma-carotene, and provitamin A carotenoids.
  • vitamin A may be included in the form of beta carotene.
  • compositions may include vitamin B9 in the form selected from one or more of the group consisting of folic acid, folinic acid, folacin, metafolin, and/or one or more natural isomers of folate including (6S)-tetrahydrofolic acid or a polyglutamyl derivative thereof, (6S,R)-tetrahydrofolic acid or a polyglutamyl derivative thereof, 5-methyl-(6S)-tetrahydrofolic acid or a polyglutamyl derivative thereof, 5-methyl-(6S,R)-tetrahydrofolic acid or a polyglutamyl derivative thereof, 5-formyl-(6S)-tetrahydrofolic acid or a polyglutamyl derivative thereof, 10-formyl-(6R)-tetrahydrofolic acid or a polyglutamyl derivative thereof, 5,10-methylene-(6R)-tetrahydrofolic acid or a polyglutamyl derivative thereof, 5,10-methen
  • compositions may include vitamin B2 in the form selected from one or more of the group consisting of flavin mononucleotide (FMN), flavin adenine dinucleotide (FAD), riboflavin (also known as 7,8-dimethyl-10-((2R,3R,4S)-2,3,4,5-tetrahydroxypentyl)benzo[g]pteridine-2,4 (3H,10H)-dione or lactoflavin) and riboflavin derivatives such as riboflavin-5′-monophosphate, riboflavin-5′-monobutyrate and riboflavin-5′-monopalmitate.
  • FMN flavin mononucleotide
  • FAD flavin adenine dinucleotide
  • riboflavin also known as 7,8-dimethyl-10-((2R,3R,4S)-2,3,4,5-tetrahydroxypentyl)benzo[g]pteridine-2,4
  • compositions may include vitamin B3 in the form selected from one or more of the group consisting of niacin (nicotinic acid or pyridine-3-carboxylic acid), and nicotinamide (niacinamide) and salts and esters thereof.
  • compositions may include vitamin B6 in the form selected from one or more of the group consisting of pyridoxine, 3-hydroxy-4,5-bis(hydroxymethyl)-2-methylpyridine, 5′-deoxypyridoxal, 2-demethylpyridoxal(2-norpyridoxal), 2-propyl-2-norpyridoxal (2′-ethylpyridoxal), 6-methylpyridoxal, 2′-hydroxypyridoxal (2-hydroxymethyl-2-demethylpyridoxal or 2-hydroxymethyl-2-norpyridoxal), 4′-deoxypyridoxine 5′-phosphate, 5′-methylpyridoxal-5′-phosphate, pyridoxal N-oxide 5′-phosphate, Pyridoxal, Pyridoxamine, Pyridoxine-5′-phosphate (PNP), pyridoxal-5′-phosphate (PLP) and pyridoxamine-5′-phosphate (PMP), and their salts and chelates thereof.
  • group consisting of pyridoxine 3-
  • compositions may include vitamin B12 in the form selected from one or more of the group consisting of cobalamin, methylcobalamin, 5′-deoxyadenosylcobalamin (adenosylcobalamin or cobamamide), cyanocobalamin, hydroxycobalamin and mecobalamin.
  • compositions may include vitamin E in the form selected from one or more of the group consisting of alpha, beta, gamma, and delta tocopherols in its natural or synthetic (dl) forms; alpha, beta, gamma, and delta tocotrienols in its natural or synthetic (dl) forms, dl-alpha tocopheryl derivatives such as dl-alpha tocopheryl esters, dl-alpha-tocopheryl acetate or succinate and d-alpha-tocopheryl acetate or dl-alpha tocopheryl phosphates (such as Ester-E®).
  • dl-alpha tocopheryl derivatives such as dl-alpha tocopheryl esters, dl-alpha-tocopheryl acetate or succinate and d-alpha-tocopheryl acetate or dl-alpha tocopheryl phosphates (such as Ester-E®).
  • compositions may include vitamin C in the form selected from one or more of the group consisting of ascorbic acid, ascorbates (calcium or sodium ascorbate), dehydroascorbic acid and salts, ascorbyl palmitate, ascorbyl phosphates and salts (such as sodium or magnesium ascorbyl phosphate), ascorbyl tetraisopalmitate, tetrahexyldecyl ascorbate, ascorbyl sulfates and salts, acylated ascorbic acid derivatives (such as 6-O-acyl-2-O-alpha-D-glucopyranosyl-L-ascorbic acids), 6-bromo-6-deoxy-L-ascorbic acid, and ascorbate salts.
  • ascorbic acid ascorbates (calcium or sodium ascorbate), dehydroascorbic acid and salts
  • ascorbyl palmitate such ascorbyl phosphates and salts (such as sodium or magnesium ascor
  • compositions may include iron in the form selected from one or more of the group consisting of elemental iron, in the form of a salt, chelated form, non-chelated form, chelated to an amino acid, carbonyl iron, ferrous gluconate, ferrous fumarate, polysaccharide iron complex, elemental polysaccharide iron, polysaccharide iron, ferrous (II)-bis-glycinate chelate, ferrous asparto glycinate, ferrous bisglycinate, ferrous bisglycinate hydrochloride, ferrous bisglycinate, elemental ferrous bisglycinate, ferrous sulfate, ferronyl (micronized), as Iron Aid, iron protein succinylate, carbonyl iron, Sumalate iron, Heme iron complex, as Ferrochel amino acid chelate, Heme iron polypeptide as Proferrin-bovine source, as heme iron polypeptide (bovine source) as sodium iron EDTA (Ferra).
  • compositions may include zinc in the form selected from one or more of the group consisting of elemental zinc, in the form of a salt, in a chelated form, in a non-chelated form, zinc acetate, zinc gluconate, zinc picolinate, zinc sulfate and zinc oxide.
  • the compositions may include copper in the form selected from one or more of the group consisting of elemental copper, in the form of a salt, in a chelated form, in a non-chelated form, cupric oxide, copper sulfate, copper gluconate, copper citrate, cupric acetate, alkaline copper carbonate, and copper salicylate.
  • compositions may include magnesium in the form selected from one or more of the group consisting of elemental magnesium, in the form of a salt, in a chelated form, in a non-chelated form, magnesium acetate, magnesium carbonate, magnesium gluconate, magnesium chloride, magnesium citrate, magnesium silicate, magnesium stearate, magnesium sulfate, magnesium oxide, and magnesium chelated to an amino acid (magnesium glycinate, magnesium aspartate).
  • elemental magnesium in the form of a salt, in a chelated form, in a non-chelated form, magnesium acetate, magnesium carbonate, magnesium gluconate, magnesium chloride, magnesium citrate, magnesium silicate, magnesium stearate, magnesium sulfate, magnesium oxide, and magnesium chelated to an amino acid (magnesium glycinate, magnesium aspartate).
  • compositions may include omega 3 fatty acids in the form selected from one or more of the group consisting docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA) and ⁇ -linolenic acid (ALA).
  • omega-3 fatty acids may comprise DHA.
  • the source of DHA is algae oil.
  • the source of the algae oil is microalgae Crypthecodinium cohnii.
  • compositions may include iodine in the form selected from one or more of the group consisting of iodide, elemental iodine, iodized salt, Lugol's iodine, sodium iodide, potassium iodide, potassium iodate, nascent iodine, and Nano-Colloidal Detoxified Iodine.
  • the compositions may include vitamin D in an amount of about 500 I.U. to about 1500 I.U., iodine in an amount of about 75 ⁇ g to about 225 ⁇ g, vitamin B1 in an amount of about 0.8 mg to about 2.4 mg, vitamin B6 in an amount of about 1.2 mg to about 3.8 mg, vitamin B12 in an amount of about 6 ⁇ g to about 18 ⁇ g, vitamin B2 in an amount of about 0.9 mg to about 2.7 mg, vitamin B9 in an amount of about 0.5 mg to about 1.5 mg, vitamin E in an amount of about 10 I.U. to about 30 I.U., vitamin A in an amount of about 550 I.U.
  • vitamin C in an amount of about 15 mg to about 45 mg
  • vitamin B3 in an amount of about 7.5 mg to about 22.5 mg
  • iron in an amount of about 14.5 mg to about 43.5 mg
  • zinc in an amount of about 12.5 mg to about 37.5 mg
  • copper in an amount of about 1.0 mg to about 3.0 mg
  • magnesium in an amount of about 10 mg to about 30 mg
  • omega 3 fatty acids in an amount of about 100 mg to about 300 mg.
  • vitamin D may be in the form of vitamin D3 and may be present in an amount of about 1000 I.U. or 25 ⁇ g. In a specific embodiment, iodine may be present in an amount of about 150 ⁇ g. In a specific embodiment, vitamin B1 may be present in an amount of about 1.6 mg. In a specific embodiment, vitamin B6 may be present in an amount of about 2.5 mg. In a specific embodiment, vitamin B12 may be present in an amount of about 12 ⁇ g. In a specific embodiment, vitamin B2 may be present in an amount of about 1.8 mg. In a specific embodiment, vitamin B9 may be present in an amount of about 1.0 mg. In a specific embodiment, vitamin E may be present in an amount of about 20 I.U.
  • vitamin A may be in the form of beta carotene and present in an amount of about 1100 I.U. or about 660 ⁇ g.
  • vitamin C may be present in an amount of about 30 mg.
  • vitamin B3 may be in the form of nicotinamide and present in an amount of about 15 mg.
  • iron may be present in an amount of about 29 mg.
  • zinc may be present in an amount of about 25 mg.
  • copper may be present in an amount of about 2.0 mg.
  • magnesium may be present in an amount of about 20 mg.
  • omega-3 fatty comprises DHA, and DHA may be present in an amount of about 200 mg.
  • compositions may be provided in a gelcap dosage form.
  • the gelcap dosage form is a liquid gelcap dosage form.
  • One embodiment of the present invention may include providing vitamin, mineral, and omega-3 fatty acid supplementation to a patient in need thereof by administering compositions disclosed herein to the patient.
  • the patient may be a female human.
  • the compositions may be administered to the female human before pregnancy, during pregnancy, after pregnancy, while breast-feeding, or a combination thereof.
  • the compositions are administered once daily to the patient.
  • the methods may comprise administering a composition comprising vitamin D in an amount of about 500 I.U. to about 1500 I.U., iodine in an amount of about 75 ⁇ g to about 225 ⁇ g, vitamin B1 in an amount of about 0.8 mg to about 2.4 mg, vitamin B6 in an amount of about 1.2 mg to about 3.8 mg, vitamin B12 in an amount of about 6 ⁇ g to about 18 ⁇ g, vitamin B2 in an amount of about 0.9 mg to about 2.7 mg, vitamin B9 an amount of about 0.5 mg to about 1.5 mg, vitamin E in an amount of about 10 I.U. to about 30 I.U., vitamin A in an amount of about 550 I.U.
  • vitamin C in an amount of about 15 mg to about 45 mg
  • vitamin B3 in an amount of about 7.5 mg to about 22.5 mg
  • iron in an amount of about 14.5 mg to about 43.5 mg
  • zinc in an amount of about 12.5 mg to about 37.5 mg
  • copper in an amount of about 1.0 mg to about 3.0 mg
  • magnesium in an amount of about 10 mg to about 30 mg
  • omega 3 fatty acids in an amount of about 100 mg to about 300 mg.
  • the methods may comprise administering a composition comprising vitamin D in an amount of about 1000 I.U., iodine in an amount of about 150 ⁇ g, vitamin B1 in an amount of about 1.6 mg, vitamin B6 in an amount of about 2.5 mg, vitamin B12 in an amount of about 12 ⁇ g, vitamin B2 in an amount of about 1.8 mg, vitamin B9 in an amount of about 1.0 mg, vitamin E in an amount of about 20 I.U., vitamin A in an amount of about 1100 I.U., vitamin C in an amount of about 30 mg, vitamin B3 in an amount of about 15 mg, iron in an amount of about 29 mg, zinc in an amount of about 25 mg, copper in an amount of about 2.0 mg, magnesium in an amount of about 20 mg, and omega 3 fatty acids comprising DHA in an amount of about 200 mg.
  • a composition comprising vitamin D in an amount of about 1000 I.U., iodine in an amount of about 150 ⁇ g, vitamin B1 in an amount of about 1.6 mg, vitamin B6 in an amount
  • disease state may comprise any state in which one or more organs or components of an organism malfunction.
  • the term “disease state” may refer to any deterioration of any component of a patient's body and specifically a human patient's body.
  • the term “disease state” may refer to any deficiency of any compound necessary for the maintenance or function of any component of any organism.
  • the term “disease state” may refer to any condition in which a body contains toxins, produced by microorganisms that infect the body or by body cells through faulty metabolism or absorbed from an external source. “Disease states” may be adverse states caused by any diet, any virus, fungi or any bacteria.
  • Disease states may comprise disorders associated with pregnant females such as, for example, osteomalacia and preeclampsia and disorders associated with a fetus such as, for example, neural tube defects and various fetal abnormalities.
  • Disease states may comprise any pulmonary disorder such as, for example, bronchitis, bronchiectasis, atelectasis, pneumonia, diseases caused by inorganic dusts, diseases caused by organic dusts, any pulmonary fibrosis, and pleurisy.
  • Disease states may comprise any hematological/oncological disorder such as, for example, anemia, hemophilia, leukemia, and lymphoma.
  • a “disease state” may comprise any cancer such as, for example, breast cancer, lung cancer, prostate cancer, pancreatic cancer, liver cancer, stomach cancer, testicular cancer, ovarian cancer, skin cancer, cancer of the brain, cancer of the mouth, cancer of the throat, and cancer of the neck.
  • “Disease states” may comprise any disorder of the immune system such as, for example, acquired immune deficiency syndrome (AIDS), AIDS-related complex, infection by any strain of any human immunodeficiency virus (HIV), and other viruses or pathogens such as bacteria, fungi and parasites.
  • AIDS acquired immune deficiency syndrome
  • HAV human immunodeficiency virus
  • a “disease state” may comprise any cardiovascular disorder such as, for example, arterial hypertension, orthostatic hypotension, arteriosclerosis, coronary artery disease, cardiomyopathy, any arrhythmia, any valvular heart disease, endocarditis, pericardial disease, any cardiac tumor, any aneurysm, and any peripheral vascular disorder.
  • “Disease states” may comprise any hepatic/biliary disorder such as, for example, jaundice, hepatic steatosis, fibrosis, cirrhosis, hepatitis, any hepatic granuloma, any liver tumor, cholelithiasis, cholecystitis, and choledocholithiasis.
  • a “disease state” may include a viral infection such as from HIV, herpes virus (HSV-1 and HSV-2), the virus that causes vesicular stomatitis (VSV), measles virus, herpes viridae, human lymprotropic visusess, vesicular stomatitis virus, visna virus, cytomegalovirus, Epstein-Barr virus, influenza virus, pneumonovirus, Sarcoma virus, Syncitial virus and Rubeola virus.
  • a “disease state” may include a fungal infection such as from Candida albicans and Giardia lamblia .
  • a “disease state” may include a bacterial infection such as from Staphylococcus, Corynebacerium, Bacillus, Listeria and Streptococcus bacteria, and include species such as Staphylococcus aureus, bacillus anthracis, Helicobacter pylori and, Listeria monocytogenes , and Streptococcus agalactiae.
  • patient comprises any and all organisms and includes the term “subject.” “Patient” may refer to a human or any other animal. “Patient” may also refer to a fetus.
  • co-administration refers to administration of two or more compositions to a patient together, which includes administration at about the same time or within a certain specific or desired time.
  • phrases “chewable form” refers to any relatively soft compositions that are chewed in the mouth after oral administration, may have a pleasant taste and mouthfeel, and may quickly break into smaller pieces and may begin to dissolve after chewing such that they can be swallowed substantially as a solution.
  • dissolvable form refers to any compositions that dissolve into a solution in the mouth. Such compositions, in one embodiment, may dissolve within about 60 seconds or less after placement in the mouth without any chewing.
  • mouthfeel refers to non-taste-related aspects of the pleasantness experienced by a person while chewing or swallowing a nutritional supplement. Aspects of mouthfeel include, for example and without limitation, the hardness and brittleness of a composition, whether the composition is chewy, gritty, oily, creamy, watery, sticky, easily dissolved, astringent, effervescent, and the like, and the size, shape, and form of the composition (tablet, powder, gel, etc.).
  • phrases “pharmaceutically acceptable,” as used herein, refers to those compounds, materials, compositions and/or dosage forms which are, within the scope of sound pharmaceutical/medical judgment, suitable for use in contact with the tissues of human beings and animals without excessive toxicity, irritation, allergic response, or other problem or complication, commensurate with a reasonable benefit/risk ratio.
  • pharmaceutically acceptable carriers refers to such suitable compounds and materials defined above that may be added to the dosage form to assist in satisfactory processing of the dosage form or provide desirable physical characteristics to the dosage form.
  • “pharmaceutically acceptable carriers” may include, but is not limited to, binders, diluents, lubricants, glidants, colorants, emulsifiers, disintegrants, starches, water, oils, alcohols, preservatives, and sugars.
  • “pharmaceutically acceptable carriers” refers to dosage forms such as capsules, caplets, gel-caps used with, for example, the compositions of the present invention comprising or consisting of omega-3 fatty acids such as docosahexaenoic acid (DHA).
  • DHA docosahexaenoic acid
  • “pharmaceutically acceptable carriers” in gel-caps may be in for example, liquid or oil form, and may include a filler or other appropriate liquid vehicle and may be used with omega-3 fatty acids such as docosahexaenoic acid (DHA) and their equivalents.
  • DHA docosahexaenoic acid
  • compositions that typically do not or are not configured to readily dissolve when placed in the mouth and may be swallowed whole, preferably without any, or with minimal, chewing or discomfort.
  • Such compositions in one embodiment, may have a shape containing no sharp edges and a smooth, uniform and substantially bubble free outer coating.
  • Dosage form is the form in which the dose is to be administered to the subject or patient.
  • the drug or supplement is generally administered as part of a formulation that includes nonmedical agents.
  • the dosage form has unique physical and pharmaceutical characteristics.
  • Dosage forms may be solid, liquid or gaseous.
  • “Dosage forms,” may include for example, a capsule, tablet, caplet, gel caplet (gelcap), syrup, a liquid composition, a powder, a concentrated powder, a concentrated powder admixed with a liquid, a chewable form, a swallowable form, a dissolvable form, an effervescent, a granulated form, and an oral liquid solution.
  • the dosage form may be a gelcap.
  • substantially free of added means free from therapeutically effective amounts of compounds when administered in suggested doses, but may include trace amounts of compounds in non-therapeutically effective amounts.
  • a composition of the present invention that included an inactive ingredient that is a salt or compound including a mineral would still be substantially free of added minerals.
  • trace amounts of titanium dioxide may be provided. Titanium dioxide which is an effective opacifier in powder form, where it is employed as a pigment to provide whiteness and opacity to numerous pharmaceutical products.
  • inactive refers to any compound that is an inactive ingredient of a described composition.
  • inactive ingredient as used herein follows that of the U.S. Food and Drug Administration, as defined in 21 C.F.R. 201.3(b)(8), which is any component of a drug product other than the active ingredient.
  • active ingredient includes any compound intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment and/or prevention of disease or a condition. See 21 C.F.R. 210.3(b)(7).
  • active ingredients include those compounds of the composition that may undergo chemical change during the manufacture of the composition and be present in the final composition in a modified form intended to furnish an activity or effect. Id. These include the vitamins, minerals and nutrients of the compositions and kits of the present invention.
  • administering refers to the act of giving a composition to a patient or otherwise making such composition available to a patient or the patient taking a composition.
  • prenatal supplementation includes optimizing specific nutrients before, during, and after the physiological processes of pregnancy and lactation, which can have profound, positive, and comprehensive impacts on the overall wellness of the developing and newborn child as well as on the safety and health of the mother.
  • Proper nutrition is essential for maintaining health and preventing diseases. Adequate nutrition is especially critical during, for example, nutritionally volatile or physiologically stressful periods such as those including, by way of example and without limitation, pregnancy, lactation, or any disease state. Vitamin and mineral needs are almost universally increased throughout these periods.
  • Increased needs during physiologically stressful states such as pregnancy, lactation or disease state may result from elevated metabolic demand, increased plasma volume, increased quantities of circulating red blood cells, decreased concentrations of nutrients, and decreased concentrations of nutrient-binding proteins such as, for example and without limitation, serum-ferritin, maltose-binding protein, lactoferrin, calmodulin, tocopheryl binding protein, riboflavin binding protein, retinol binding protein, transthyretin, high density lipoprotein-apolipoprotein A1, folic acid binding protein, and 25-hydroxyvitamin D binding protein.
  • Lapido, 72 (Supp.) A MER . J. C LIN . N UTR. 280S-90S (2000).
  • compositions, kits and methods of the present invention may thus provide the means to optimize good health by utilizing vitamin, mineral, and nutritional supplementation.
  • the compositions, kits and methods of the present invention may be administered to or directed to a subject such as a human or any other organism.
  • compositions, kits and methods of the present invention may include vitamin A.
  • Vitamin A is involved in physiological processes that result in cellular differentiation, cellular maturity, and cellular specificity.
  • vitamin A is an important component of a nutritional supplement for subjects in physiologically stressful states, such as those caused by pregnancy, lactation or disease state.
  • supplemental vitamin A ingestion during pregnancy has been shown in some studies to be teratogenic or deforming to human and animal embryos.
  • vitamin A may be in a form that is a precursor (pro-vitamin) or metabolite of vitamin A that provides similar nutritional value as vitamin A.
  • the pro-vitamin A carotenoid may be beta carotene. Beta carotene is converted to other forms of vitamin A, specifically retinol, within the body as needed, thereby avoiding the risk of retinol toxicity. Mayne, FASEB J 10:690-701 (1996).
  • vitamin A may be in one or more of the forms of retinol acetate (also known as retinyl acetate or vitamin A acetate), retinol (vitamin A alcohol), retinol palmitate (also known as retinyl palmitate or vitamin A palmitate), retinoic acid (tretinoin), retinal, beta-cryptoxanthin, alpha-carotene, beta-carotene, gamma-carotene, and provitamin A carotenoids.
  • retinol acetate also known as retinyl acetate or vitamin A acetate
  • retinol vitamin A alcohol
  • retinol palmitate also known as retinyl palmitate or vitamin A palmitate
  • retinoic acid tretinoin
  • retinal beta-cryptoxanthin
  • alpha-carotene beta-carotene
  • beta-carotene gamma-carotene
  • vitamin A may be in the form of beta carotene as beta carotene also has powerful anti-oxidant properties.
  • Antioxidants are important during physiologically stressful events for numerous reasons. For example, lipid peroxidation has been associated with over 200 disease processes. Rock et al., 96(7) J. A MER . D IET . A SSOC. 693-702 (1996). Antioxidants are especially important during pregnancy because in the first trimester, establishment of blood flow into the intervillous space is associated with a burst of oxidative stress. The inability to mount an effective antioxidant defense against this burst results in early pregnancy loss. Myatt & Cui, 122, H ISTOCHEM . C ELL B IOL., 369-82 (2004).
  • oxidative stress has been implicated in the pathophysiology of preeclampsia, a toxemia of pregnancy. Llurba et al., 37(4) F REE R ADIC . B IOL . M ED. 557-70 (2004). Finally, oxidative stress during pregnancy plays an important role in fetal growth, and healthy antioxidant levels are positively correlated with birth weight and length. Myatt & Cui; Lee et al., 58 E UR . J. C UL . N UTR., 481-87 (2004).
  • vitamin A may be included in amounts ranging from about 550 IU to about 1650 IU. In another specific embodiment, vitamin A may be included in amounts ranging from about 880 IU to about 1320 IU. In another specific embodiment, vitamin A may be included in amounts ranging from about 990 IU to about 1210 IU. In another embodiment, vitamin A may be included in an amount of about 1100 IU.
  • vitamin A may be included in specific ranges or amounts for each specific form.
  • the provided numerical range or amount includes the amounts of the specific form and/or compounds that are equivalent to the specific form.
  • vitamin A may be in the form of beta carotene and may be included in the amount of about 1100 IU.
  • “beta carotene in the amount of about 1100 IU” would include 1000 IU of beta carotene and/or its equivalents and would, for example, include a product having 1100 IU retinol acetate instead of beta carotene.
  • vitamin A in the form of beta carotene may be included in amounts ranging from about 550 IU to about 1650 IU. In another specific embodiment, vitamin A in the form of beta carotene may be included in amounts ranging from about 880 IU to about 1320 IU. In another specific embodiment, vitamin A in the form of beta carotene may be included in amounts ranging from about 990 IU to about 1210 IU. In another embodiment, vitamin A in the form of beta carotene may be included in an amount of about 1100 IU. In another specific embodiment of the compositions, kits and methods of the present invention, vitamin A may be included in the form of beta carotene and one or more forms of vitamin A. In a specific embodiment, the compositions, kits and methods of the present invention may include beta carotene and retinol. In another embodiment, the compositions, kits and methods of the present invention may include beta carotene and retinol acetate.
  • vitamin A may be present in an amount determined by a measure of mass, as opposed to International Units.
  • One International Unit (IU) of vitamin A is defined as the biological equivalent of about 0.6 ⁇ g of beta carotene, or about 0.3 ⁇ g of retinol. See R EMINGTON , T HE S CIENCE AND P RACTICE OF P HARMACY , page 1804(20 th ed 2000). Accordingly, 550 IU to about 1650 IU is the biological equivalent of about 330 ⁇ g to about 990 ⁇ g. In another example, about 880 IU to about 1320 IU is the biological equivalent of about 528 ⁇ g to about 792 ⁇ g. In another example, about 990 IU to about 1210 IU is the biological equivalent of about 594 ⁇ g to about 726 ⁇ g. In another example, 1100 IU is the biological equivalent of about 660 ⁇ g.
  • compositions, kits and methods of the present invention may comprise or use one or more B-complex vitamins.
  • This class of vitamins comprises water-soluble nutrients generally not stored in the body. They play roles in a variety of biological processes critical to the health of pregnant women, lactating women, and fetuses such as, for example, the metabolism of homocysteine.
  • the B-complex vitamins that may be included in the compositions, kits and methods of the present invention comprise one or more of vitamin B1, vitamin B2, vitamin B3, vitamin B6, vitamin B9 and vitamin B12.
  • compositions, kits and methods of the present invention may comprise or use vitamin B1.
  • Vitamin B1 plays a role in carbohydrate metabolism and neural function. It is a coenzyme for the oxidative decarboxylation of alpha-ketoacids (e.g., alpha-ketoglutarate and pyruvate) and for transketolase, which is a component of the pentose phosphate pathway.
  • alpha-ketoacids e.g., alpha-ketoglutarate and pyruvate
  • transketolase which is a component of the pentose phosphate pathway.
  • vitamin B1 may be in one or more of the forms of thiamine, thiamine monophosphate, thiamine diphosphate, thiamine triphosphate, acetiamine, allithiamine, prosultiamine and S-acyl derivatives of thiamine such as benfotiamine, fursultiamine and salts and esters thereof.
  • vitamin B1 may be included in amounts ranging from about 0.8 mg to about 2.4 mg. In another specific embodiment, vitamin B1 may be included in amounts ranging from about 1.3 mg to about 1.9 mg. In another specific embodiment, vitamin B1 may be included in amounts ranging from about 1.4 mg to about 1.75 mg. In another embodiment, vitamin B1 may be included in an amount of about 1.6 mg.
  • vitamin B1 may be included in specific ranges or amounts for each specific form.
  • the provided numerical range or amount includes the amounts of the specific form and/or compounds that are equivalent to the specific form.
  • vitamin B1 may be in the form of thiamine mononitrate and may be included in the amount of about 1.6 mg.
  • “thiamine mononitrate in the amount of about 1.6 mg” would include 1.6 mg of thiamine mononitrate and/or its equivalents and would, for example, include a product having 1.6 mg allithiamine instead of thiamine mononitrate.
  • compositions, kits and methods of the present invention may comprise or use vitamin B2.
  • Vitamin B2 is a component of two flavin coenzymes, flavin mononucleotide (FMN) and flavin adenine dinucleotide (FAD). These flavoenzymes are involved in a number of oxidation-reduction reactions including the conversion of pyridoxine and niacin. RDA, supra at 132. Flavoenzymes also play a role in a number of metabolic pathways such as amino acid deamination, purine degradation and fatty acid oxidation and thus help to maintain carbohydrate, amino acid and lipid metabolism.
  • vitamin B2 may be in one or more of the forms of flavin mononucleotide (FMN), flavin adenine dinucleotide (FAD), riboflavin (also known as 7,8-dimethyl-10-((2R,3R,4S)-2,3,4,5-tetrahydroxypentyl)benzo[g]pteridine-2,4 (3H,10H)-dione or lactoflavin) and riboflavin derivatives such as riboflavin-5′-monophosphate, riboflavin-5′-monobutyrate and riboflavin-5′-monopalmitate.
  • vitamin B2 may be included in the form of riboflavin.
  • vitamin B2 may be included in amounts ranging from about 0.9 mg to about 2.7 mg. In another specific embodiment, vitamin B2 may be included in amounts ranging from about 1.5 mg to about 2.2 mg. In another specific embodiment, vitamin B2 may be included in amounts ranging from about 1.6 mg to about 2 mg. In another embodiment, vitamin B2 may be included in an amount of about 1.8 mg.
  • vitamin B2 in the form of riboflavin may be included in amounts ranging from about 0.9 mg to about 2.7 mg. In another specific embodiment, vitamin B2 in the form of riboflavin may be included in amounts ranging from about 1.5 mg to about 2.2 mg. In another specific embodiment, vitamin B2 in the form of riboflavin may be included in amounts ranging from about 1.6 mg to about 2 mg. In another embodiment, vitamin B2 in the form of riboflavin may be included in an amount of about 1.8 mg.
  • vitamin B2 may be included in specific ranges or amounts for each specific form.
  • the provided numerical range or amount includes the amounts of the specific form and/or compounds that are equivalent to the specific form.
  • vitamin B2 may be in the form of riboflavin and may be included in the amount of about 1.8 mg. Accordingly, in this example, “riboflavin in the amount of about 1.8 mg” would include 1.8 mg of riboflavin and/or its equivalents and would, for example, include a product having 1.8 mg flavin mononucleotide instead of riboflavin.
  • compositions, kits and methods of the present invention may comprise or use vitamin B3.
  • Vitamin B3, or “niacin” is the common name for two compounds: nicotinic acid (also called niacin) and niacinamide (also called nicotinamide).
  • Vitamin B3 is particularly important for maintaining healthy levels and types of fatty acids. It is also required for the synthesis of pyroxidine, riboflavin, and folic acid. RDA, supra at 137.
  • Administration of vitamin B3 also may effect a reduction in total cholesterol (LDL) and very low density lipoprotein (VLDL) levels and an increase in high density lipoprotein (HDL) cholesterol levels.
  • LDL total cholesterol
  • VLDL very low density lipoprotein
  • HDL high density lipoprotein
  • Nicotinamide adenine dinucleotide (NAD) and NAD phosphate (NADP) are active coenzymes of niacin. These coenzymes are involved in numerous enzymatic reactions such as glycolysis, fatty acid metabolism, and steroid synthesis. Henkin et al., 91 A M . J. M ED. 239-46 (1991).
  • vitamin B3 may in the forms of niacin (nicotinic acid or pyridine-3-carboxylic acid), and nicotinamide (niacinamide) and salts and esters thereof.
  • vitamin B3 may be included in the form of nicotinamide.
  • the present invention may include an equivalent molar amount of niacin.
  • vitamin B3 may be included in amounts ranging from about 7.5 mg to about 22.5 mg. In another specific embodiment, vitamin B3 may be included in amounts ranging from about 12 mg to about 18 mg. In another specific embodiment, vitamin B3 may be included in amounts ranging from about 13.5 mg to about 16.5 mg. In another embodiment, vitamin B3 may be included in an amount of about 15 mg.
  • vitamin B3 may be included in specific ranges or amounts for each specific form.
  • the provided numerical range or amount includes the amounts of the specific form and/or compounds that are equivalent to the specific form.
  • vitamin B3 may be in the form of nicotinamide and may be included in the amount of about 15 mg. Accordingly, in this example, “nicotinamide in the amount of about 15 mg” would include 15 mg of nicotinamide and/or its equivalents and would, for example, include a product having 15 mg niacin instead of nicotinamide.
  • vitamin B3 in the form of nicotinamide may be included in amounts ranging from about 7.5 mg to about 22.5 mg. In another specific embodiment, vitamin B3 in the form of nicotinamide may be included in amounts ranging from about 12 mg to about 18 mg. In another specific embodiment, vitamin B3 in the form of nicotinamide may be included in amounts ranging from about 13.5 mg to about 16.5 mg. In another embodiment, vitamin B3 in the form of nicotinamide may be included in an amount of about 15 mg.
  • compositions, kits and methods of the present invention may comprise or use vitamin B6.
  • the administration of vitamin B6 may reduce the levels of homocysteine. Bostom et al., 49 K IDNEY I NT. 147-52 (1996).
  • the active forms of vitamin B6, pyridoxal-5′-phosphate (PLP) and pyridoxamine-5′-phosphate, are coenzymes for numerous enzymes and as such, are important for gluconeogenesis, niacin formation, and erythrocyte metabolism. RDA, supra at 142-43.
  • Vitamin B6 is a coenzyme for both cystathionine synthase and cystathionase, enzymes that catalyze the formation of cysteine from methionine.
  • Homocysteine is an intermediate in this process and elevated levels of plasma homocysteine are recognized as a risk factor for both vascular disease (Robinson et al., 94 C IRCULATION 2743-48 (1996)) and neural tube defects (Locksmith & Duff, 91 O BSTET . G YNECOL. 1027-34 (1998)).
  • vitamin B6 may be included in the forms of pyridoxine, 3-hydroxy-4,5-bis(hydroxymethyl)2-methylpyridine, 5′-deoxypyridoxal, 2-demethylpyridoxal(2-norpyridoxal), 2-propyl-2-norpyridoxal (2′-ethylpyridoxal), 6-methylpyridoxal, 2′-hydroxypyridoxal (2-hydroxymethyl-2-demethylpyridoxal or 2-hydroxymethyl-2-norpyridoxal), 4′-deoxypyridoxine 5′-phosphate, 5′-methylpyridoxal-5′-phosphate, pyridoxal N-oxide 5′-phosphate, Pyridoxal, Pyridoxamine, Pyridoxine-5′-phosphate (PNP), pyridoxal-5′-phosphate (PLP) and pyridoxamine-5′-phosphate (PMP), and their salts and chelates thereof.
  • vitamin B6 may be included in the forms of pyridoxine, 3-hydroxy-4,5-bis
  • vitamin B6 may be included in specific ranges or amounts for each specific form.
  • the provided numerical range or amount includes the amounts of the specific form and/or compounds that are equivalent to the specific form.
  • vitamin B6 may be in the form of pyridoxine hydrochloride and may be included in the amount of about 2.5 mg. Accordingly, in this example, “pyridoxine hydrochloride in the amount of about 2.5 mg” would include 2.5 mg of pyridoxine hydrochloride and/or its equivalents and would, for example, include a product having 2.5 mg pyridoxamine instead of pyridoxine hydrochloride.
  • vitamin B6 may be included in amounts ranging from about 1.2 mg to about 3.8 mg. In another specific embodiment, vitamin B6 may be included in amounts ranging from about 2.0 mg to about 3.0 mg. In another specific embodiment, vitamin B6 may be included in amounts ranging from about 2.25 mg to about 2.75 mg. In another embodiment, vitamin B6 may be included in an amount of about 2.5 mg.
  • compositions, kits and methods of the present invention may comprise or use vitamin B9.
  • Vitamin B9 is a generic name of a B-vitamin that includes multiple compounds with a general structure.
  • vitamin B9 encompasses the term folate, which itself is the generic name for many different forms of this water-soluble vitamin (vitamin B9), which is essential for DNA synthesis and, hence, cell division.
  • folate a water-soluble vitamin
  • Simpson et al. T HE J OURNAL OF M ATERNAL -F ETAL AND N EONATAL M EDICINE, Micronutrients and women of reproductive potential: required dietary intake and consequences of dietary deficiency or excess. Part I—Folate, Vitamin B 12 , Vitamin B 6, Epub 1-21, (2010).
  • folate encompasses numerous compounds that for example, are based on a pteridine ring, an aminobenzoic acid and one or more glutamic acid residues.
  • Folic acid pteroglutamic acid or PGA
  • the term folates may also be used in the generic sense to designate any members of the family of pteroylglutamates, or mixtures of them, having various levels of reduction of the pteridine ring, one-carbon substitutions and numbers of glutamate residues.
  • Vitamin B9 is not only defined by its structure, but also by its various functions. Indeed, vitamin B9 is essential for DNA synthesis and, hence, cell division and is required metabolically as a coenzyme in one-carbon transfer reactions. Simpson, supra. This vitamin has demonstrated the ability to prevent neural tube defects such as spina bifida caused by disturbed homocysteine metabolism. Vanderput et al., E XP . B IOL . M ED. 243-70 (2001); DeFalco et al., 27 C LIN . E XP . O BSTET . G YNECOL. 188-90 (2000); Eskes, 27 C LIN . E XP . O BSTET . G YNECOL.
  • Folic acid a commonly used term synonymous with vitamin B9, is known to reduce the risk of multiple diseases.
  • Clinical trials definitively demonstrated the effectiveness of folic acid supplementation in reducing the number of neural tube defects.
  • vitamin B9 may include numerous forms.
  • vitamin B9 may be included in the form of folic acid.
  • vitamin B9 may be included one or more of the forms of folic acid, folacin, metafolin, folate and/or one or more natural isomers of folate including (6S)-tetrahydrofolic acid or a polyglutamyl derivative thereof, 5-methyl-(6S)-tetrahydrofolic acid or a polyglutamyl derivative thereof, 5-formyl-(6S)-tetrahydrofolic acid or a polyglutamyl derivative thereof, 10-formyl-(6R)-tetrahydrofolic acid or a polyglutamyl derivative thereof, 5,10-methylene-(6R)-tetrahydrofolic acid or a polyglutamyl derivative thereof, 5,10-methenyl-(6R)-tetrahydrofolic acid or a polyglutamyl derivative
  • vitamin B9 may be in the form of a folate or folate derivative thereof that is eventually converted to 5-methyl-tetrahydrofolic acid in the body and/or is absorbed into the bloodstream as 5-methyl-tetrahydrofolic acid. Folates, such as folic acid and folate, are eventually absorbed in the body and converted to L-5-methyl-tetrahydrofolic acid 1n another embodiment, vitamin B9 may be in the form of a folate or folate derivative thereof that increases blood folate levels, thereby reducing homocysteine levels.
  • vitamin B9 may be in the form of folate or reduced folates with various salts.
  • the folate and reduced folate are selected from the group consisting of D-glucosamine-folate, D-galactosamine-folate, D-glucosamine (6R,S)-tetrahydrofolate, D-glucosamine (6S)-tetrahydrofolate, D-glucosamine (6R)-tetrahydrofolate; D-galactosamine (6R,S)-tetrahydrofolate, D-galactosamine (6S)-tetrahydrofolate, D-galactosamine (6R)-tetrahydrofolate; D-glucosamine 5-methyl-(6R,S)-tetrahydrofolate, D-glucosamine 5-methyl-(6S)-tetrahydrofolate, D-glucosamine 5-methyl-(6R)-tetrahydrofolate; D-galgalactosamine-t
  • vitamin B9 may be included in amounts ranging from about 0.5 mg to about 1.5 mg. In another specific embodiment, vitamin B9 may be included in amounts ranging from about 0.8 mg to about 1.2 mg. In another specific embodiment, vitamin B9 may be included in amounts ranging from about 0.9 mg to about 1.1 mg. In another embodiment, vitamin B9 may be included in an amount of about 1.0 mg.
  • vitamin B9 may be included in specific ranges or amounts for each specific form.
  • the provided numerical range or amount includes the amounts of the specific form and/or compounds that are equivalent to the specific form.
  • vitamin B9 may be in the form folic acid and may be included in the amount of about 1.0 mg.
  • “folic acid in the amount of about 1.0 mg” would include 1.0 mg of folic acid and/or its equivalents and would, for example, include a product having 1.0 mg 5-methyl-(6S)-tetrahydrofolic acid instead of folic acid.
  • vitamin B9 may be in the form of folic acid. In another specific embodiment, vitamin B9 in the form of folic acid may be included in amounts ranging from about 0.5 mg to about 1.5 mg. In another specific embodiment, vitamin B9 in the form of folic acid may be included in amounts ranging from about 0.8 mg to about 1.2 mg. In another specific embodiment, vitamin B9 in the form of folic acid may be included in amounts ranging from about 0.9 mg to about 1.1 mg. In another embodiment, vitamin B9 in the form of folic acid may be included in an amount of about 1.0 mg.
  • compositions, kits and methods of the present invention may comprise or use vitamin B12.
  • Vitamin B12 can be converted to the active coenzymes, methylcobalamin and 5′-deoxyadenosylcobalamin. These coenzymes are necessary for folic acid metabolism, conversion of coenzyme A and myelin synthesis.
  • Methylcobalamin also catalyzes the demethylation of a folate cofactor which is involved in DNA synthesis. A lack of demethylation may result in folic acid deficiency. RDA, supra at 159-160.
  • Deoxyadenosylcobalamin is the coenzyme for the conversion of methylmalonyl-CoA to succinyl-CoA, which plays a role in the citric acid cycle.
  • Cobalamin, along with pyridoxine and folic acid, also are implicated in the proper metabolism of homocysteine, a breakdown product of the amino acid methionine, which is correlated with an increased risk of heart disease due to its negative effects on endothelial function.
  • vitamin B12 may be in one or more of the forms of cobalamin, methylcobalamin, 5′-deoxyadenosylcobalamin (adenosylcobalamin or cobamamide), cyanocobalamin, hydroxycobalamin and mecobalamin.
  • vitamin B12 may be included in amounts ranging from about 6 ⁇ g to about 18 ⁇ g. In another specific embodiment, vitamin B12 may be included in amounts ranging from about 9.6 ⁇ g to about 14.4 ⁇ g. In another specific embodiment, vitamin B12 may be included in amounts ranging from about 10.8 ⁇ g to about 13.2 ⁇ g. In another embodiment, vitamin B12 may be included in an amount of about 12 ⁇ g.
  • vitamin B12 may be included in specific ranges or amounts for each specific form.
  • the provided numerical range or amount includes the amounts of the specific form and/or compounds that are equivalent to the specific form.
  • vitamin B12 may be in the form cyanocobalamin and may be included in the amount of about 12 ⁇ g. Accordingly, in this example, “cyanocobalamin in the amount of about 12 ⁇ g” would include 12 ⁇ g of cyanocobalamin and/or its equivalents and would, for example, include a product having 12 ⁇ g methylcobalamin instead of cyanocobalamin.
  • compositions, kits and methods of the present invention may comprise or use vitamin C.
  • the major biochemical role of water-soluble vitamin C is as a co-substrate in metal catalyzed hydroxylations.
  • vitamin C has antioxidant properties. It interacts directly with superoxide hydroxyl radicals and singlet oxygen, and also provides antioxidant protection for folate and vitamin E, keeping vitamin E in its most potent form. Vitamin C may afford protective effects against preeclampsia by participating in the scavenging of free radicals. Indeed, significantly lower levels of vitamin C have been observed in preeclamptic women than in controls. Woods et al., 185(1) A M . J. O BSTET . G YNECOL.
  • Vitamin C also enhances the absorption of iron. RDA, supra at 115.
  • vitamin C is required for collagen synthesis, epinephrine synthesis, and bile acid formation.
  • vitamin C has been implicated in inhibiting atherosclerosis by being present in extracellular fluid of the arterial wall and potentiating nitric oxide activity, thus normalizing vascular function.
  • vitamin C may be included in the forms of ascorbic acid, ascorbates (calcium or sodium ascorbate), dehydroascorbic acid and salts, ascorbyl palmitate, ascorbyl phosphates and salts (such as sodium or magnesium ascorbyl phosphate), ascorbyl tetraisopalmitate, tetrahexyldecyl ascorbate, ascorbyl sulfates and salts, acylated ascorbic acid derivatives (such as 6-O-acyl-2-O-alpha-D-glucopyranosyl-L-ascorbic acids), 6-bromo-6-deoxy-L-ascorbic acid, and ascorbate salts.
  • vitamin C may be included in the form of ascorbic acid.
  • vitamin C may be included in amounts ranging from about 15 mg to about 45 mg. In another specific embodiment, vitamin C may be included in amounts ranging from about 24 mg to about 36 mg. In another specific embodiment, vitamin C may be included in amounts ranging from about 27 mg to about 33 mg. In another embodiment, vitamin C may be included in an amount of about 30 mg.
  • vitamin C may be included in specific ranges or amounts for each specific form.
  • the provided numerical range or amount includes the amounts of the specific form and/or compounds that are equivalent to the specific form.
  • vitamin C may be in the form ascorbic acid and may be included in the amount of about 30 mg. Accordingly, in this example, “ascorbic acid in the amount of about 30 mg” would include 30 mg of ascorbic acid and/or its equivalents and would, for example, include a product having 30 mg ascorbyl palmitate instead of ascorbic acid.
  • vitamin C in the form of ascorbic acid may be included in amounts ranging from about 15 mg to about 45 mg. In another specific embodiment, vitamin C in the form of ascorbic acid may be included in amounts ranging from about 24 mg to about 36 mg. In another specific embodiment, vitamin C in the form of ascorbic acid may be included in amounts ranging from about 27 mg to about 33 mg. In another embodiment, vitamin C in the form of ascorbic acid may be included in an amount of about 30 mg.
  • compositions, kits and methods of the present invention may comprise or use vitamin D.
  • the compositions and methods of the present invention may include a beneficially increased supplementation of vitamin D.
  • Vitamin D is a fat-soluble “hormone like” substance important for the maintenance of healthy bones. This vitamin increases the absorption of calcium and phosphorous from the gastrointestinal tract, and improves mineral resorption into bone tissue. The result of this physiological function is a correlation between adequate systemic levels in pregnancy and a long-lasting reduction in osteoporotic fractures throughout the lifespan of the newborn.
  • vitamin D has more positive physiological effects than previous thought. Bischoff-Ferrari HA, 624 A DV E XP M ED B IOL. 55-71 (2008); Holick M F, 357 N. E NG . J. M ED. 266-81, (2007); Parikin et al., 89(3) J C LIN E NDOCRINOL M ETAB. 1196-99 (2004).
  • vitamin D also has a role in the enhancement of vascular function, defense against cancer, immuno-competence, blood pressure regulation and possessing the ability to enhance cellular insulin sensitivity in the human body.
  • Vitamin D status during pregnancy is more important than previous thought. Vitamin D's role continues to expand in for example, infant immunity, neurodevelopment, birth weight, and incidence of asthma. Growing research findings regarding the importance of this hormone-like compound is due, in large part, to the fact that vitamin D receptors have now been identified on nearly every tissue and cell in the human body. H F DeLuca et al., FASEB J 15:2579-2585 (2001); D.
  • one embodiment of the present invention includes compositions, kits and methods that provide a beneficial increased supplementation of vitamin D, specifically, for example prenatal, pregnant or breast feeding women.
  • vitamin D of the compositions and methods of the present invention may comprise vitamin D.
  • vitamin D may be in one or more the forms of vitamin D3 (also known as calciol or cholecalciferol or colecalciferol), vitamin D2 (also known as calciferol, ergocalciol, ergocalciferol, ercalciol, Deltalin or Viosterol), previtamin D2, ergosterol, calcitriol (also known as 1,25-dihydroxycholecalciferol), 7-dehydrocholesterol, vitamin D1, vitamin D4 (also known as 22-dihydroergocalciferol, 22,23-dihydroercalciol or (24S)-methylcalciol), vitamin D5 (also known as (24S)-Ethylcalciol or sitocalciferol), 7-dehydrositosterol, Lumisterol, 25-hydroxyvitamin D, all steroids that exhibit
  • vitamin D may be present in the amount ranging from about 400 IU to about 1600 IU. In another embodiment, vitamin D may be present in the amount ranging from about 750 IU to about 1250 IU. In another embodiment, vitamin D is present in the amount ranging form about 900 IU to about 1100 IU. In another embodiment, vitamin D is present in the amount of about 1000 IU.
  • vitamin D may be included in specific ranges or amounts for each specific form.
  • the provided numerical range or amount includes the amounts of the specific form and/or compounds that are equivalent to the specific form.
  • vitamin D may be in the form vitamin D3 and may be included in the amount of about 1000 IU.
  • “vitamin D3 in the amount of about 30 mg” would include 1000 IU of vitamin D3 and/or its equivalents and would, for example, include a product having 1000 IU mg vitamin D2 instead of vitamin D3.
  • the vitamin D of the compositions, kits and methods of the present invention may be vitamin D3.
  • vitamin D3 is produced when its precursor is exposed to ultraviolet irradiation (e.g., sunlight) and then hydroxylated in the liver to form 25-hydroxyvitamin D3, the major form of vitamin D in the circulation.
  • This form of the vitamin may be hydroxylated again in the kidney, yielding 1,25 hydroxyvitamin D3, the most potent form of vitamin D.
  • vitamin D3 plays a role in the maintenance of calcium and phosphorus homeostasis, but it is also active in cell differentiation and immune function.
  • vitamin D in the form of vitamin D3 may be present in the amount ranging from about 400 IU to about 1600 IU. In another embodiment, vitamin D in the form of vitamin D3 may be present in the amount ranging from about 750 IU to about 1250 IU. In another embodiment, vitamin D in the form of vitamin D3 may be present in the amount ranging form about 900 IU to about 1100 IU. In another embodiment, vitamin D in the form of vitamin D3 may be present in the amount of about 1000 IU.
  • vitamin D may be present in an amount determined by a measure of mass, as opposed to International Units.
  • One International Unit (IU) of vitamin D is defined as the biological equivalent of about 0.025 ⁇ g of vitamin D3. See R EMINGTON , T HE S CIENCE AND P RACTICE OF P HARMACY , page 1800 (20 th ed 2000) (hereinafter, “Remington”). Accordingly, 400 IU to about 1600 IU is the biological equivalent of about 10 ⁇ g to about 40 ⁇ g. In another example, about 750 IU to about 1250 IU is the biological equivalent of about 18.75 ⁇ g to about 31.25 ⁇ g. In another example, about 900 IU to about 1100 IU is the biological equivalent of about 22.5 ⁇ g to about 27.5 ⁇ g. In another example, 1000 IU is the biological equivalent of about 25 ⁇ g.
  • compositions, kits and methods of the present invention may comprise or use vitamin E.
  • Vitamin E is a fat-soluble vitamin antioxidant found in biological membranes where it protects the phospholipid membrane from oxidative stress. Vitamin E inhibits the oxidation of unsaturated fatty acids by trapping peroxyl free radicals. It is also an antiatherogenic agent, and studies have demonstrated a reduced risk of coronary heart disease with increased intake of vitamin E. Stampfer et al., 328 N EW E NG . J. M ED. 1444-49 (1993).
  • vitamin E like beta carotene and vitamin C, may afford protective effects against preeclampsia by participating in the scavenging of free radicals.
  • vitamin E may be included in one or more of the forms of alpha, beta, gamma, and delta tocopherols in its natural or synthetic (dl) forms; alpha, beta, gamma, and delta tocotrienols in its natural or synthetic (dl) forms, dl-alpha tocopheryl derivatives such as dl-alpha tocopheryl esters, dl-alpha-tocopheryl acetate or succinate and d-alpha-tocopheryl acetate or dl-alpha tocopheryl phosphates (such as Ester-E®).
  • dl-alpha tocopheryl derivatives such as dl-alpha tocopheryl esters, dl-alpha-tocopheryl acetate or succinate and d-alpha-tocopheryl acetate or dl-alpha tocopheryl phosphates (such as Ester-E®).
  • vitamin E may be included in the form of d-alpha-tocopheryl acetate. In another specific embodiment, vitamin E may be included in the form of an equivalent molar amount of d-alpha tocopheryl succinate.
  • vitamin E may be included in amounts ranging from about 10 IU to about 30 IU. In another specific embodiment, vitamin E may be included in amounts ranging from about 15 IU to about 25 IU. In another specific embodiment, vitamin E may be included in amounts ranging from about 18 IU to about 22 IU. In another embodiment, vitamin E may be included in an amount of about 20 IU.
  • vitamin E may be included in specific ranges or amounts for each specific form.
  • the provided numerical range or amount includes the amounts of the specific form and/or compounds that are equivalent to the specific form.
  • vitamin E may be in the form d-alpha-tocopheryl acetate and may be included in the amount of about 20 IU.
  • “d-alpha-tocopheryl in the amount of about 20 IU” would include 20 IU of d-alpha-tocopheryl and/or its equivalents and would, for example, include a product having 20 IU alpha-tocotrienol instead of d-alpha-tocopheryl.
  • compositions, kits and methods of the present invention may comprise or use iron.
  • a primary function of iron is to carry oxygen to bodily tissues via the hemoglobin part of red blood cells. Supplemental intake of iron is critical to preventing anemia, a disorder associated with a variety of physiological states including, for example, pregnancy. Bothwell, 72(Supp.) A M . J. C LIN . N UTR. 257S-64S (2000). Severe anemia may have adverse effects upon a mother and a fetus. Specifically, significant depression of hemoglobin has been associated with poor pregnancy outcome. Black, supra; Sifakis & Pharmakides, 900 A NN . N.Y. A CAD . S CI. 125-36 (2000).
  • compositions, kits and methods of the present invention may include iron in one or more of the forms of elemental iron, in the form of a salt, chelated form, non-chelated form, chelated to an amino acid, carbonyl iron, ferrous gluconate, ferrous fumarate, polysaccharide iron complex, elemental polysaccharide iron, polysaccharide iron, ferrous (II)-bis-glycinate chelate, ferrous asparto glycinate, ferrous bisglycinate, ferrous bisglycinate hydrochloride, ferrous bisglycinate, elemental ferrous bisglycinate, ferrous sulfate, ferronyl (micronized), as Iron Aid, iron protein succinylate, carbonyl iron, Sumalate iron, Heme iron complex, as Ferrochel amino acid chelate, heme iron polypeptide as Proferrin-bovine source, as heme iron polypeptide (bovine source) as sodium iron EDTA (Ferra
  • iron may be included in the form of polysaccharide iron complex. In another specific embodiment, iron may be included in the form of an equivalent molar amount of ferrous fumurate. In another specific embodiment, iron may be included in amounts ranging from about 14.5 mg to about 43.5 mg. In another specific embodiment, iron may be included in amounts ranging from about 21.6 mg to about 32.4 mg. In another specific embodiment, iron may be included in amounts ranging from about 26 mg to about 32 mg. In another embodiment, iron may be included in an amount of about 29 mg.
  • iron may be included in specific ranges or amounts for each specific form.
  • the provided numerical range or amount includes the amounts of the specific form and/or compounds that are equivalent to the specific form.
  • iron may be in the form polysaccharide iron complex and may be included in the amount of about 29 mg.
  • polysaccharide iron complex in the amount of about 29 mg would include 29 mg of polysaccharide iron complex and/or its equivalents and would, for example, include a product having 29 mg ferrous fumarate instead of polysaccharide iron complex.
  • compositions, kits and methods of the present invention may comprise or use iodine.
  • Iodine provides nutritional benefits as it is an essential component of the thyroid hormones that are involved in the regulation of various enzymes and metabolic processes, such as thyroxine and triiodothyronine.
  • Thyroid hormones play pivotal roles in metabolism. Consequences of deficiency (hypothyroidism) and excess (hyperthyroidism) are well-recognised clinically.
  • Simpson et al. T HE J OURNAL OF M ATERNAL -F ETAL AND N EONATAL M EDICINE, Micronutrients and women of reproductive potential: required dietary intake and consequences of dietary deficiency or excess.
  • iodine deficiency disorders include mental retardation, hypothyroidism, goiter, cretinism, and varying degrees of other growth and developmental abnormalities which can be a result from inadequate thyroid hormone production from lack of sufficient iodine.
  • IDD iodine deficiency disorders
  • iodine is an important element in breast milk for infant nutrition. An adequate concentration of iodine in breast milk is essential to provide for optimal neonatal thyroid hormone stores and to prevent impaired neurological development in breast-fed neonates. In many countries of the world, low iodine content of the breast milk indicates less than optimum maternal and infant iodine nutrition.
  • one embodiment of the present invention includes compositions, kits and methods that provide a beneficial increased supplementation of iodine, specifically, for example prenatal, pregnant or breast feeding women.
  • iodine may be in the forms of elemental iodine, iodized salt, Lugol's iodine, sodium iodide, potassium iodide, potassium iodate, nascent iodine, and Nano-Colloidal Detoxified Iodine.
  • iodine may be present in the amounts ranging from about 75 ⁇ g to about 225 ⁇ g. In another embodiment, iodine may be present in the amounts ranging from about 120 ⁇ g to about 180 ⁇ g. In another embodiment, iodine may be present in the amounts ranging from about 135 ⁇ g to about 165 ⁇ g. In another embodiment, iodine may be present in the amount of about 150 ⁇ g.
  • iodine may be included in specific ranges or amounts for each specific form.
  • the provided numerical range or amount includes the amounts of the specific form and/or compounds that are equivalent to the specific form.
  • iodine may be in the form potassium iodide and may be included in the amount of about 150 ⁇ g.
  • “potassium iodide in the amount of about 150 ⁇ g” would include 150 ⁇ g of potassium iodide and/or its equivalents and would, for example, include a product having 150 ⁇ g Nano-Colloidal Detoxified Iodine instead of potassium iodide.
  • compositions, kits and methods of the present invention may comprise or use magnesium.
  • Magnesium is found primarily in both bone and muscle and is important for over 300 different enzyme reactions. A primary function of magnesium is to bind to phosphate groups in adenosine triphosphate (ATP), thereby forming a complex that assists in the transfer of ATP phosphate.
  • ATP adenosine triphosphate
  • Magnesium also functions within cells as a membrane stabilizer. Magnesium plays roles in nucleic acid synthesis, glycolysis, transcription of DNA and RNA, amino acid activation, membrane transport, transketolase reactions, and protein synthesis. James L. L. Groff et al., A DVANCED N UTRITION AND H UMAN M ETABOLISM 341 (2d ed. 1996).
  • cAMP a cytosolic second messenger that plays a role in cell signaling mechanisms.
  • Magnesium also functions both synergistically and antagonistically with calcium in neuromuscular transmission. RDA, supra at 188.
  • magnesium is critical for the maintenance of electrochemical potentials of nerve and muscle membranes and the neuromuscular junction transmissions, particularly important in the heart.
  • magnesium deficiency is tied to cardiovascular disease and hypertension. Agus et al., 17 C RIT . C ARE C LIN. 175-87 (2001). Indeed, oral magnesium therapy improves endothelial function in patients with coronary disease. Shechter et al., 102 C IRCULATION 2353-58 (2000).
  • magnesium is available in a variety of salts and can be included in the compositions, kits and methods of the present invention in either chelated or nonchelated form.
  • magnesium may be included in the forms of elemental magnesium, in the form of a salt, in a chelated form, in a non-chelated form, magnesium acetate, magnesium carbonate, magnesium gluconate, magnesium chloride, magnesium citrate, magnesium silicate, magnesium stearate, magnesium sulfate, magnesium oxide, and magnesium chelated to an amino acid (magnesium glycinate, magnesium aspartate).
  • magnesium may be present in the amounts ranging from about 10 mg to about 30 mg. In another embodiment, magnesium may be present in the amounts ranging from about 16 mg to about 24 mg. In another embodiment, magnesium may be present in the amounts ranging from about 18 mg to about 22 mg. In another embodiment, magnesium may be present in the amount of about 20 mg.
  • magnesium may be included in specific ranges or amounts for each specific form.
  • the provided numerical range or amount includes the amounts of the specific form and/or compounds that are equivalent to the specific form.
  • magnesium may be in the form magnesium oxide and may be included in the amount of about 20 mg. Accordingly, in this example, “magnesium oxide in the amount of about 20 mg” would include 20 mg of magnesium oxide and/or its equivalents and would, for example, include a product having 20 mg magnesium stearate instead of magnesium oxide.
  • compositions, kits and methods of the present invention may comprise or use zinc.
  • Zinc plays a role in numerous metabolic activities such as nucleic acid production, protein synthesis, and development of the immune system. There are more than 200 zinc metalloenzymes including aldolase, alcohol dehydrogenase, RNA polymerase, and protein kinase C. Zima et al., 17 B LOOD P URIF. 182-86 (1999).
  • Zinc stabilizes RNA and DNA structures, forms zinc fingers in nuclear receptors, and is a component of chromatin proteins involved in transcription and replication. Deficiencies of zinc during pregnancy have been shown to contribute to severe fetal abnormalities. Srinivas et al., 68(6) I NDIAN J. P EDIATR.
  • Zinc is available in many forms and may be included in the kits and methods of the present invention in chelated or nonchelated form.
  • zinc may be provided in one or more of the forms of elemental zinc, in the form of a salt, in a chelated form, in a non-chelated form, zinc acetate, zinc gluconate, zinc picolinate, zinc sulfate and zinc oxide.
  • zinc may be included in the form of zinc oxide.
  • zinc may be included in amounts ranging from about 12.5 mg to about 37.5 mg.
  • zinc may be included in amounts ranging from about 20 mg to about 30 mg.
  • zinc may be included in amounts ranging from about 22.5 mg to about 27.5 mg.
  • zinc may be included in an amount of about 25 mg.
  • zinc may be included in specific ranges or amounts for each specific form.
  • the provided numerical range or amount includes the amounts of the specific form and/or compounds that are equivalent to the specific form.
  • zinc may be in the form zinc oxide and may be included in the amount of about 25 mg. Accordingly, in this example, “zinc oxide in the amount of about 25 mg” would include 25 mg of zinc oxide and/or its equivalents and would, for example, include a product having 25 mg zinc sulfate instead of zinc oxide.
  • compositions, kits and methods of the present invention may comprise or use copper.
  • Copper is an important component of the process of gene expression. Additionally, one of copper's most vital roles is to help form hemoglobin, which, as previously discussed, carries oxygen to tissues via its iron component. In this respect copper plays a key role in protecting against anemia. Further, deficiencies of copper may lead to neutropenia and bone abnormalities in pregnant and lactating women. Uauy et al., AMER J CLIN NUTR 67:952 S-959S (Supp.) (1998).
  • a fetus must accumulate copper at a rate of 50 mcg ⁇ kg ⁇ 1 ⁇ d ⁇ 1 over the latter half of pregnancy; any deficiency in accumulation may lead to low birth weight and protein-energy malnutrition.
  • copper may be included in the forms of a salt, in a chelated form, in a non-chelated form, cupric oxide, copper sulfate, copper gluconate, copper citrate, cupric acetate, alkaline copper carbonate, and copper salicylate.
  • copper may be included in amounts ranging from about 1.0 mg to about 3.0 mg. In another specific embodiment, copper may be included in amounts ranging from about 1.6 mg to about 2.4 mg. In another specific embodiment, copper may be included in amounts ranging from about 1.8 mg to about 2.2 mg. In another embodiment, copper may be included in an amount of about 2.0 mg.
  • copper may be included in specific ranges or amounts for each specific form.
  • the provided numerical range or amount includes the amounts of the specific form and/or compounds that are equivalent to the specific form.
  • copper may be in the form copper oxide and may be included in the amount of about 2.0 mg. Accordingly, in this example, “copper oxide in the amount of about 2.0 mg” would include 2.0 mg of copper oxide and/or its equivalents and would, for example, include a product having 2.0 mg copper sulfate instead of copper oxide.
  • compositions, kits and methods of the present invention may comprise or use omega-3 fatty acids.
  • Omega-3 fatty acids play integral roles in physiological mechanisms that serve to prevent, treat and/or alleviate the occurrence or negative effects of some diseases and has shown multiple health-promoting properties in adults.
  • omega-3 fatty acids are linked to health benefits such as preventing the occurrence of cancer, preventing the occurrence of heart disease, and are helpful in brain health and immune function.
  • omega-3 fatty acids include essential fatty acids linked to numerous health benefits, such as docahexaenoic acid (or docosahexaenoic acid, DHA), eicosapentaenoic acid (EPA) and a-linolenic acid (ALA).
  • compositions, kits and methods of the present invention may comprise or use Docahexaenoic acid (or docosahexaenoic acid, DHA).
  • compositions, kits and methods of the present invention may comprise or use eicosapentaenoic acid (EPA).
  • compositions, kits and methods of the present invention may comprise or use a-linolenic acid (ALA).
  • DHA omega-3 fatty acid
  • EPA EPA
  • ambulatory blood pressure and heart rate in hyperlipidemic men.
  • the results of this study thus suggest that DHA is the principal fatty acid in fish and fish oils that is responsible for blood pressure and heart rate effects in humans. Id.
  • DHA is vital for optimal fetal and infant brain/cognitive development, as well as for normal brain function throughout life.
  • the sleep patterns of infants born to mothers with higher plasma phospholipid DHA suggest greater central nerve system maturity.
  • ADHD Attention Deficit Hyperactivity Disorder
  • DHA is also important for the development of the infant retina and improving the visual acuity of the infant.
  • Preterm infants have a more rapid development of visual acuity if fed human milk or formula enriched with DHA, compared to standard formula.
  • An increase in visual acuity has also been observed to develop more rapidly in term infants breast-fed from mothers whose diets are supplemented with DHA. Id.
  • this essential fatty acid has also shown multiple health-promoting properties in adults. These include anti-thrombotic, anti-inflammatory and anti-atherosclerotic activity, all of which reduce the risk of heart disease.
  • M Laidlaw and B J Holub A M J C LIN N UTR 77:37-42 (2003).
  • Inverse relationships have also been found between systemic levels of omega-3 fatty acids such as DHA and incidence and severity of mood disorders and depression, including postpartum depression. Therefore, introduction of omega-3 during pregnancy has a double benefit, to both child and mother.
  • DHA is particularly useful in counteracting the progression of breast cancer.
  • Human breast cancer cells exposed to DHA exhibit an increase in cell death by apoptosis.
  • DHA also inhibits cyclooxygenase-2, which promotes mammary carcinogenesis. Id.
  • DHA supplementation during pregnancy has also been shown to increase the length of gestation by about six days, helping mothers carry to a healthy full term.
  • omega-3 fatty acids such as DHA not only leads to their incorporation into cell membrane lipids (B A Stoll, B R J N UTR 87(3):193-198 (2002)), but also storage in adipose tissue and secretion in breast milk.
  • alpha-linolenic acid fatty acid
  • a rich dietary source of direct DHA is fish. Id. However, some lactating women are vegetarians, have limited access to fish or simply do not like fish.
  • MeHg methyl mercury
  • DHA may be obtained in solid form, such as in a whole-cell microbial product, or in liquid form, such as in an oil.
  • An example of DHA in oil form is DHASCO®-T vegetable oil from micro-algae (Martek Biosciences Corporation, Columbia, Md.).
  • the DHA is DHAgold®, life'sDHATM (DHASCO®), any Algae Oil, Krill Oil and/or vegetarian DHA.
  • the source of DHA may be from one or more of animal, fish, plants, algae or microorganism production.
  • compositions, kits and methods of the present invention may include DHA derived from algae.
  • DHA derived from algae as opposed to being derived from fish oil, has numerous beneficial effects.
  • the DHA from algae does not have the “fishy” smell that can come with DHA from fish oil. Indeed, high doses of DHA from fish oil may result in the patient having an unappealing after taste or a slight “fishy” body odor or “fishy” odor on the patient's breath.
  • DHA derived from algae can be more easily regulated to assure consistency and further remove the risk of added chemicals or other dangers. For example, DHA from algae would not have the risk of being tainted with mercury as opposed to DHA from fish oil.
  • the source of DHA may be from algae oil.
  • the source of algae oil may be one or more of microalgae Schizochytrium sp, microalgae Crypthecodinium cohnii , microalgae Ulkenia sp. SAM2179, microalgae Schizochytrium linacinum strain SC-1.
  • the source of DHA may be Martek Oil C53-O100.
  • omega-3 fatty acids may be included in amounts ranging from about 100 mg to about 300 mg. In another specific embodiment, omega-3 fatty acids may be included in amounts ranging from about 160 mg to about 240 mg. In another specific embodiment, omega-3 fatty acids may be included in amounts ranging from about 180 mg to about 220 mg. In another embodiment, omega-3 fatty acids may be included in an amount of about 200 mg.
  • omega-3 fatty acids may be included in specific ranges or amounts for each specific form.
  • the provided numerical range or amount includes the amounts of the specific form and/or compounds that are equivalent to the specific form.
  • omega-3 fatty acids may be in the form of DHA and may be included in the amount of about 200 mg. Accordingly, in this example, “DHA in the amount of about 200 mg” would include 200 mg of DHA and/or its equivalents and would, for example, include a product having 200 mg EPA instead of DHA.
  • omega-3 fatty acids may be in the form of DHA and may be included in amounts ranging from about 100 mg to about 300 mg. In another specific embodiment, omega-3 fatty acids in the form of DHA may be included in amounts ranging from about 160 mg to about 240 mg. In another specific embodiment, omega-3 fatty acids in the form of DHA may be included in amounts ranging from about 180 mg to about 220 mg. In another embodiment, omega-3 fatty acids in the form of DHA may be included in an amount of about 200 mg.
  • compositions, kits and methods of the present invention may include or use a combination of the included vitamins, nutrients and minerals just described.
  • the compositions, kits and methods of the present invention may include vitamin D, iodine, vitamin B1, vitamin B6, vitamin B12, vitamin B2, vitamin B9, vitamin B3, vitamin E, vitamin A, vitamin C, iron, zinc, copper, magnesium, omega 3 fatty acids and one or more pharmaceutically acceptable carriers.
  • the vitamins, nutrients and minerals may be included or used in any specific form just described.
  • the omega 3 fatty acids may be DHA.
  • compositions, kits and methods of the present invention may include or use a combination of the included vitamins, nutrients and minerals in the ranges or amounts just described.
  • compositions, kits and methods of the present invention may include or use vitamin D in an amount of about 500 I.U. to about 1500 I.U., iodine in an amount of about 75 ⁇ g to about 225 ⁇ g, vitamin B1 in an amount of about 0.8 mg to about 2.4 mg, vitamin B6 in an amount of about 1.2 mg to about 3.8 mg, vitamin B12 in an amount of about 6 ⁇ g to about 18 ⁇ g, vitamin B2 in an amount of about 0.9 mg to about 2.7 mg, vitamin B9 in an amount of about 0.5 mg to about 1.5 mg, vitamin E in an amount of about 10 I.U. to about 30 I.U., vitamin A in an amount of about 550 I.U.
  • vitamin C in an amount of about 15 mg to about 45 mg
  • vitamin B3 in an amount of about 7.5 mg to about 22.5 mg
  • iron in an amount of about 14.5 mg to about 43.5 mg
  • zinc in an amount of about 12.5 mg to about 37.5 mg
  • copper in an amount of about 1.0 mg to about 3.0 mg
  • magnesium in an amount of about 10 mg to about 30 mg
  • omega 3 fatty acids comprising DHA in an amount of about 100 mg to about 300 mg.
  • composition s, kits and methods of the present invention may include or use vitamin D in an amount of about 1000 I.U., iodine in an amount of about 150 ⁇ g, vitamin B1 in an amount of about 1.6 mg, vitamin B6 in an amount of about 2.5 mg, vitamin B12 in an amount of about 12 ⁇ g, vitamin B2 in an amount of about 1.8 mg, vitamin B9 in an amount of about 1.0 mg, vitamin E in an amount of about 20 I.U., vitamin A in an amount of about 1100 I.U., vitamin C in an amount of about 30 mg, vitamin B3 in an amount of about 15 mg, iron in an amount of about 29 mg, zinc in an amount of about 25 mg, copper in an amount of about 2.0 mg, magnesium in an amount of about 20 mg, and omega 3 fatty acids comprising DHA in an amount of about 200 mg.
  • vitamin D in an amount of about 1000 I.U.
  • iodine in an amount of about 150 ⁇ g
  • vitamin B1 in an amount of about 1.6 mg
  • vitamin B6 in
  • vitamin D3, iodine, vitamin B1, vitamin B6, vitamin B12, vitamin B2, vitamin B9, vitamin B3, vitamin E, vitamin A, vitamin C, iron, zinc, copper, magnesium, and omega 3 fatty acids may be provided in one composition.
  • the composition may be in the dosage form of a gelcap.
  • various inactive ingredients and pharmaceutically acceptable carries may be added.
  • a wetting, stabilizing agent may be used for the gelcap composition,
  • the wetting or stabilizing agent is lecithin oil.
  • beeswax may be added.
  • soybean oil may be added.
  • the present invention may comprise one or more compositions in a kit.
  • the one or more compositions may include or use a combination of the vitamins, nutrients and minerals just described.
  • the one or more compositions may collectively use or include vitamin D, iodine, vitamin B1, vitamin B6, vitamin B12, vitamin B2, vitamin B9, vitamin B3, vitamin E, vitamin A, vitamin C, iron, zinc, copper, magnesium, omega 3 fatty acids and one or more pharmaceutically acceptable carriers.
  • the two compositions may collectively use or include vitamin D, iodine, vitamin B1, vitamin B6, vitamin B12, vitamin B2, vitamin B9, vitamin B3, vitamin E, vitamin A, vitamin C, iron, zinc, copper, magnesium, omega 3 fatty acids and one or more pharmaceutically acceptable carriers.
  • the multiple compositions, kits and methods of the present invention may collectively include or use vitamin D in an amount of about 500 I.U. to about 1500 I.U., iodine in an amount of about 75 ⁇ g to about 225 ⁇ g, vitamin B1 in an amount of about 0.8 mg to about 2.4 mg, vitamin B6 in an amount of about 1.2 mg to about 3.8 mg, vitamin B12 in an amount of about 6 ⁇ g to about 18 ⁇ g, vitamin B2 in an amount of about 0.9 mg to about 2.7 mg, vitamin B9 in an amount of about 0.5 mg to about 1.5 mg, vitamin E in an amount of about 10 I.U. to about 30 I.U., vitamin A in an amount of about 550 I.U.
  • vitamin C in an amount of about 15 mg to about 45 mg
  • vitamin B3 in an amount of about 7.5 mg to about 22.5 mg
  • iron in an amount of about 14.5 mg to about 43.5 mg
  • zinc in an amount of about 12.5 mg to about 37.5 mg
  • copper in an amount of about 1.0 mg to about 3.0 mg
  • magnesium in an amount of about 10 mg to about 30 mg
  • omega 3 fatty acids comprising DHA in an amount of about 100 mg to about 300 mg.
  • the multiple compositions, kits and methods of the present invention may collectively include or use vitamin D in an amount of about 1000 I.U., iodine in an amount of about 150 ⁇ g, vitamin B1 in an amount of about 1.6 mg, vitamin B6 in an amount of about 2.5 mg, vitamin B12 in an amount of about 12 ⁇ g, vitamin B2 in an amount of about 1.8 mg, vitamin B9 in an amount of about 1.0 mg, vitamin E in an amount of about 20 I.U., vitamin A in an amount of about 1100 I.U., vitamin C in an amount of about 30 mg, vitamin B3 in an amount of about 15 mg, iron in an amount of about 29 mg, zinc in an amount of about 25 mg, copper in an amount of about 2.0 mg, magnesium in an amount of about 20 mg, and omega 3 fatty acids comprising DHA in an amount of about 200 mg
  • active ingredients such as the vitamins, minerals and nutrients of the present invention, may be included in overages. Adding overages of these compounds may be necessary to meet the amounts claimed on the product label and product insert to ensure that those recited amounts are met throughout the shelf life of the product. Indeed, because of US regulatory requirements that label values reflect minimum contents of these nutrients, deviations in actual nutrient content from label values are usually thought to tend toward overages. Dwyer et al., A NAL B IOANAL C HEM, 389:37-46 (2007).
  • one or more of the vitamins, minerals and nutrients may be included in the compositions and methods of the present invention in overages of the recited, specific label amounts of about 100% to about 150% of the label amount, although the overages are dependant on the stability of each ingredient.
  • overages of vitamin D and vitamin B12 may be necessary due to the lack of stability of specific forms.
  • 5-methyltetrahydrofolate, a form of vitamin B9 is degraded by light, temperature and may degrade during processing and storage.
  • Overages may be larger for some vitamins particularly those that are less stable and more likely to deteriorate with a long shelf life, those that have other functions (such as antioxidants) in the product itself; for minerals, excess amounts with large overages are probably less likely because of their increased bulk and shelf life stability. Dwyer et al., A NAL B IOANAL C HEM. 389:37-46 (2007). Accordingly, when overages are included for any specific active ingredient, at some point in time, these ingredients with overages will degrade so that they fall within the amounts provided in the specific label. Thus, there is no literal difference between the amounts for active ingredients that include overages, and those amounts listed on the specific label. Furthermore, overages provide an equivalent efficacy of the active ingredient over the shelf life of the product. Accordingly, an active ingredient provided in overage amounts is an insubstantial change and performs substantially the same function, in substantially the same way, and leads to substantially the same result as that same active ingredient in the amounts as provided on the specific label.
  • the nutritional supplements may include multiple vitamins, nutrients and minerals in one composition.
  • Providing a single composition multivitamin and multinutrient supplement is an appealing feature because it improves patient compliance. Patients, and specifically for example, pregnant patients, often have nausea, and may have difficulties taking multiple pills.
  • a one pill or one composition nutritional supplement that includes the beneficial vitamins, nutrients and minerals in appropriate dosage amounts would thus be beneficial for improving patient compliance in for example, pregnant women.
  • one or more of the compositions may be in the dosage form of a gelcap.
  • compositions, kits and methods of the present invention may be in the form of a liquid gelcap which may consist of a filler comprising one or more pharmaceutically active materials dissolved or dispersed in an appropriate liquid vehicle encapsulated in a gelatin shell generally comprising gelatin together with a plasticizer such as glycerin or sorbitol.
  • the filler material may comprise, for example, polyethylene glycols. See, for example, U.S. Pat. Nos. 4,780,316; 5,419,916; 5,641,512; and 6,589,536 which are expressly incorporated by reference herein.
  • a liquid gelcap has numerous advantages. First, it retains many of the advantages of consumer acceptance and is easier to swallow due to the outer coating being a soft and elastic gelatin shell. Also, liquid compositions are well suited for encapsulation within a soft gelatin shell, creating flexibility that further assists in the capsule being easier to swallow.
  • the active drug contained in the liquid form also has advantages in dispersing the drug to the active site. For example, the active drug does not first have to dissolve in the gastrointestinal tract, thereby facilitating absorption of the pharmacologically active substance. See, for example, U.S. Pat. No. 6,689,382 which is expressly incorporated by reference herein.
  • the present invention may comprise kits or compositions in the dosage form of a soft-gel gelcap.
  • a soft-gel is a one-piece, sealed, soft gelatin shell that contains a solution, a suspension, or a semi-solid paste.
  • Soft-gels are predominantly used to contain liquids wherein the active ingredients are present in the dissolved or suspended state.
  • Soft-gels have been widely known and used for many years and for a variety of purposes. Because soft-gels have properties that are quite different from two-piece, hard shell capsules, the soft-gels are capable of retaining a liquid fill material. Soft-gels are often used to encapsulate consumable materials, including vitamins, dietary supplements, pharmaceuticals, and the like, in a liquid vehicle or carrier.
  • Soft-gels are a unique dosage form that can provide distinct advantages over more traditional dosage forms such as tablets, hard-shell capsules, and liquids. These advantages include patient compliance and consumer preference, improved bioavailability, speed of product development in many cases, shortened manufacturing time, enhanced drug stability due to less exposure of the active ingredient to oxygen, excellent dose uniformity, and product differentiation.
  • the nutritional supplements may include multiple vitamins, nutrients and minerals in more than one composition.
  • various active ingredients may be incorporated into multiple compositions as a kit.
  • fat soluble compounds such as omega 3 fatty acids
  • water soluble vitamins such as B-complex vitamins and vitamin C
  • the multiple compositions may be separated due to size or the large dosage amounts of specific ingredients.
  • the nutritional supplementation of a multivitamin may not be adequate in one composition. Accordingly, all the active ingredients may be divided into a total of two compositions, three compositions, four compositions and five composition.
  • each composition may have equal amounts of each active ingredient.
  • compositions may have unequal amounts of various active ingredients, or merely supplemental amounts of specific active ingredients.
  • compositions, kits and methods may be used as a dietary supplement.
  • the composition, kits and methods may be used as a prescription prenatal vitamin.
  • the compositions, kits and methods of the present invention may be administered to a patient, such as a woman during pregnancy, prenatal or who is breast-feeding.
  • the compositions, kits and methods of the present invention may be utilized or administered, once a day, twice a day, three times a day, four times a day and five times a day. When multiple compositions are provided in a kit, the compositions may be co-administered at the same or administered separately.
  • compositions, kits and methods of the present invention may be used or utilized in one or more dosage forms.
  • the dosage form more be a capsule, tablet, caplet, gel caplet (gelcap), syrup, a liquid composition, a concentrated powder, and a concentrated powder admixed with a liquid.
  • the kits may comprise multiple compositions utilizing multiple dosage forms.
  • compositions of the present invention may thus be combined into a composition which may be in the form of capsule, tablet, caplet, gel caplet (gelcap), syrup, a liquid composition, a concentrated powder, and a concentrated powder admixed with a liquid, and which may be administered alone or in suitable combination with other components.
  • the composition of the present invention may be administered in one or more caplets or gel caps as practical for ease of administration.
  • Each of the vitamins, nutrients and minerals is commercially available, and can be blended to form a single composition or can form multiple compositions, which may be co-administered.
  • one or more of the compositions may be in the dosage form of a gelcap.
  • each of the active ingredients may be combined in intimate admixture with a suitable carrier according to conventional compounding techniques.
  • the carrier may take a wide variety of forms depending upon the form of the preparation desired for administration, e.g., oral, sublingual, nasal, topical patch, or parenteral.
  • any of the usual media may be utilized.
  • liquid preparations e.g., suspensions, elixirs, and solutions
  • media containing, for example water, oils, alcohols, flavoring agents, preservatives, coloring agents and the like may be used.
  • Pharmaceutical acceptable carriers such as starches, sugars, diluents, granulating agents, lubricants, binders, disintegrating agents and the like may be used to prepare oral solids (e.g., powders, caplets, pills, tablets, capsules, and lozenges). Controlled release forms may also be used. Because of their ease in administration, caplets, tablets, pills, and capsules represent the most advantageous oral dosage unit form, in which case solid carriers are employed.
  • tablets may be sugar coated or enteric coated by standard techniques. All of these pharmaceutical carriers and formulations are well known to those of ordinary skill in the art. See, e.g., WADE & WALLER, HANDBOOK OF PHARMACEUTICAL EXCIPIENTS (2nd ed. 1994).
  • the dosage forms may be swallowable, chewable or dissolvable.
  • Swallowable compositions are well known in the art and are those that do not readily dissolve when placed in the mouth and may be swallowed whole without any chewing or discomfort.
  • the swallowable compositions may have a shape containing no sharp edges and a smooth, uniform and substantially bubble free outer coating.
  • each of the active ingredients may be combined in intimate admixture with a suitable carrier according to conventional compounding techniques.
  • the surface of the compositions may be coated with a polymeric film.
  • Such a film coating has several beneficial effects. First, it reduces the adhesion of the compositions to the inner surface of the mouth, thereby increasing the patient's ability to swallow the compositions. Second, the film may aid in masking the unpleasant taste of certain drugs. Third, the film coating may protect the compositions of the present invention from atmospheric degradation.
  • Polymeric films that may be used in preparing the swallowable compositions of the present invention include vinyl polymers such as polyvinylpyrrolidone, polyvinyl alcohol and acetate, cellulosics such as methyl and ethyl cellulose, hydroxyethyl cellulose and hydroxylpropyl methylcellulose, acrylates and methacrylates, copolymers such as the vinyl-maleic acid and styrene-maleic acid types, and natural gums and resins such as zein, gelatin, shellac and acacia
  • Pharmaceutical carriers and formulations for swallowable compounds are well known to those of ordinary skill in the art. See generally, e.g., WADE & WALLER, HANDBOOK OF PHARMACEUTICAL EXCIPIENTS (2nd ed. 1994).
  • Chewable compositions are those that have a palatable taste and mouthfeel, are relatively soft and quickly break into smaller pieces and begin to dissolve after chewing such that they are swallowed substantially as a solution.
  • chewable compositions In order to create chewable compositions, certain ingredients should be included to achieve the attributes just described.
  • chewable compositions should include ingredients that create pleasant flavor and mouthfeel and promote relative softness and dissolvability in the mouth. The following discussion describes ingredients that may help to achieve these characteristics.
  • Chewable compositions preferably have a pleasant or palatable flavor and a pleasant mouthfeel.
  • a variety of ingredients can be included in the compositions of the present invention to enhance mouthfeel.
  • sugars such as white sugar, corn syrup, sorbitol (solution), maltitol (syrup), oligosaccharide, isomaltooligosaccharide, sucrose, fructose, lactose, glucose, lycasin, xylitol, lactitol, erythritol, mannitol, isomaltose, dextrose, polydextrose, dextrin, compressible cellulose, compressible honey, compressible molasses and mixtures thereof may be added to improve mouthfeel and palatability.
  • sugars such as white sugar, corn syrup, sorbitol (solution), maltitol (syrup), oligosaccharide, isomaltooligosaccharide, sucrose, fructose, lactose, glucose, lycasin, xylitol, lactitol, erythritol, mannitol, isomaltose, dex
  • fondant or gums such as gelatin, agar, arabic gum, guar gum, and carrageenan may be added to improve the chewiness of the compositions.
  • Fatty materials that may be included in the present invention include, by way of example and without limitation, vegetable oils (including palm oil, palm hydrogenated oil, corn germ hydrogenated oil, castor hydrogenated oil, cotton-seed oil, olive oil, peanut oil, palm olein oil, and palm stearin oil), animal oils (including refined oil and refined lard whose melting point ranges from 30° to 42° C.), Cacao fat, margarine, butter, and shortening.
  • Alkyl polysiloxanes (commercially available polymers sold in a variety of molecular weight ranges and with a variety of different substitution patterns) also may be used in the present invention to enhance the texture, the mouthfeel, or both of the chewable nutritional supplement compositions described herein.
  • “enhance the texture” it is meant that the alkyl polysiloxane improves one or more of the stiffness, the brittleness, and the chewiness of the chewable supplement, relative to the same preparation lacking the alkyl polysiloxane.
  • enhance the mouthfeel it is meant that the alkyl polysiloxane reduces the gritty texture of the supplement once it has liquefied in the mouth, relative to the same preparation lacking the alkyl polysiloxane.
  • Alkyl polysiloxanes generally comprise a silicon and oxygen-containing polymeric backbone with one or more alkyl groups pending from the silicon atoms of the back bone. Depending upon their grade, they can further comprise silica gel. Alkyl polysiloxanes are generally viscous oils. Exemplary alkyl polysiloxanes that can be used in the swallowable, chewable or dissolvable compositions of the present invention include, by way of example and without limitation, monoalkyl or dialkyl polysiloxanes, wherein the alkyl group is independently selected at each occurrence from a C 1 -C 6 -alkyl group optionally substituted with a phenyl group.
  • simethicone dimethyl polysiloxane
  • simethicone GS a granular simethicone preparation designated simethicone GS may be used.
  • Simethicone GS is a preparation which contains 30% simethicone USP.
  • Simethicone USP contains not less than about 90.5% by weight (CH 3 ) 3 —Si ⁇ OSi(CH 3 ) 2 ⁇ CH 3 in admixture with about 4.0% to about 7.0% by weight SiO 2 .
  • Chewable compositions should begin to break and dissolve in the mouth shortly after chewing begins such that the compositions can be swallowed substantially as a solution.
  • the dissolution profile of chewable compositions may be enhanced by including rapidly water-soluble fillers and excipients. Rapidly water-soluble fillers and excipients preferably dissolve within about 60 seconds of being wetted with saliva. Indeed, it is contemplated that if enough water-soluble excipients are included in the compositions of the present invention, they may become dissolvable rather than chewable composition forms.
  • rapidly water soluble fillers suitable for use with the present invention include, by way of example and without limitation, saccharides, amino acids and the like.
  • Disintegrants also may be included in the compositions of the present invention in order to facilitate dissolution.
  • Disintegrants including permeabilising and wicking agents, are capable of drawing water or saliva up into the compositions which promotes dissolution from the inside as well as the outside of the compositions.
  • Such disintegrants, permeabilising and/or wicking agents include, by way of example and without limitation, starches, such as corn starch, potato starch, pre-gelatinized and modified starches thereof, cellulosic agents, such as Ac-di-sol, montrnorrilonite clays, cross-linked PVP, sweeteners, bentonite, microcrystalline cellulose, croscarmellose sodium, alginates, sodium starch glycolate, gums, such as agar, guar, locust bean, karaya, pectin, Arabic, xanthan and tragacanth, silica with a high affinity for aqueous solvents, such as colloidal silica, precipitated silica, maltodextrins, beta-cyclodextrins,
  • compositions may be facilitated by including relatively small particles sizes of the ingredients used.
  • any appropriate fillers and excipients may be utilized in preparing the swallowable, chewable and/or dissolvable compositions of the present invention so long as they are consistent with the objectives described herein.
  • binders are substances used to cause adhesion of powder particles in granulations.
  • Such compounds appropriate for use in the present invention include, by way of example and without limitation, acacia, compressible sugar, gelatin, sucrose and its derivatives, maltodextrin, cellulosic polymers, such as ethylcellulose, hydroxypropylcellulose, hydroxypropylmethyl cellulose, carboxymethylcellulose sodium and methylcellulose, acrylic polymers, such as insoluble acrylate ammoniomethacrylate copolymer, polyacrylate or polymethacrylic copolymer, povidones, copovidones, polyvinylalcohols, alginic acid, sodium alginate, starch, pregelatinized starch, guar gum, polyethylene glycol and others known to those of ordinary skill in the art.
  • acacia compressible sugar, gelatin, sucrose and its derivatives, maltodextrin
  • cellulosic polymers such as ethylcellulose, hydroxypropylcellulose, hydroxypropylmethyl cellulose, carboxymethylcellulose sodium and methyl
  • Diluents also may be included in the compositions of the present invention in order to enhance the granulation of the compositions.
  • Diluents can include, by way of example and without limitation, microcrystalline cellulose, sucrose, dicalcium phosphate, starches, lactose and polyols of less than 13 carbon atoms, such as mannitol, xylitol, sorbitol, maltitol and pharmaceutically acceptable amino acids, such as glycin, and their mixtures.
  • Lubricants are substances used in composition formulations that reduce friction during composition compression.
  • Lubricants that may be used in the present invention include, by way of example and without limitation, stearic acid, calcium stearate, magnesium stearate, zinc stearate, talc, mineral and vegetable oils, benzoic acid, poly(ethylene glycol), glyceryl behenate, stearyl futmarate, and others known to those of ordinary skill in the art.
  • Glidants improve the flow of powder blends during manufacturing and minimize composition weight variation.
  • Glidants that may be used in the present invention include, by way of example and without limitation, silicon dioxide, colloidal or fumed silica, magnesium stearate, calcium stearate, stearic acid, cornstarch, talc and others known to those of ordinary skill in the art.
  • Colorants also may be included in the nutritional supplement compositions of the present invention.
  • the term “colorant” includes compounds used to impart color to pharmaceutical preparations. Such compounds include, by way of example and without limitation, FD&C Red No. 3, FD&C Red No. 20, FD&C Yellow No. 6, FD&C Blue No. 2, D&C Green No. 5, FD&C Orange No. 5, D&C Red No. 8, caramel, and ferric oxide, red and others known to those of ordinary skill in the art.
  • Coloring agents also can include pigments, dyes, tints, titanium dioxide, natural coloring agents, such as grape skin extract, beet red powder, beta carotene, annato, carmine, turneric, paprika and others known to those of ordinary skill in the art. It is recognized that no colorant is required in the nutritional supplement compositions described herein.
  • compositions of the present invention may be sugar coated or enteric coated by standard techniques.
  • the unit dose forms may be individually wrapped, packaged as multiple units on paper strips or in vials of any size, without limitation.
  • the swallowable, chewable or dissolvable compositions of the present invention may be packaged in unit dose, rolls, bulk bottles, blister packs and combinations thereof, without limitation.
  • the swallowable, chewable or dissolvable compositions of the present invention may be prepared using conventional methods and materials known in the pharmaceutical art.
  • U.S. Pat. Nos. 5,215,754 and 4,374,082 relate to methods for preparing swallowable compositions.
  • U.S. Pat. No. 6,495,177 relates to methods to prepare chewable nutritional supplements with improved mouthfeel.
  • U.S. Pat. No. 5,965,162 relates to kits and methods for preparing multi-vitamin comestible units which disintegrate quickly in the mouth, especially when chewed.
  • all pharmaceutical carriers and formulations described herein are well known to those of ordinary skill in the art, and determination of workable proportions in any particular instance will generally be within the capability of the person skilled in the art.
  • a specific embodiment of the present invention may comprise kits or swallowable compositions packaged in blister packs.
  • Blister packs as packaging for swallowable compositions are well known to those of ordinary skill in the art.
  • Blister packs may be made of a transparent plastic sheet which as been formed to carry a matrix of depression or blisters.
  • One or more swallowable compositions are received in each depression or blister.
  • a foil or plastic backing is then adhered across the plane of the sheet sealing the swallowable compositions in their respective blisters.
  • Examples of materials used for the blister packs include, but are not limited to, aluminum, paper, polyester, PVC, and polypropylene. Alternative materials are known to those of ordinary skill in the art.
  • To remove a swallowable composition the depression material is pressed in and the composition is pushed through the backing material.
  • Multiple blister packs may be placed in an outer package, often a box or carton for sale and distribution.
  • kits or swallowable compositions packaged in bottles may comprise kits or swallowable compositions packaged in bottles.
  • the bottle may be glass or plastic in form with a pop or screw top cap.
  • Bottle packaging for compositions in swallowable form are well known to those of ordinary skill in the art.
  • unit dose forms may be individually wrapped, packaged as multiple units on paper strips or in vials of any size, without limitation.
  • the swallowable, chewable or dissolvable compositions of the invention may be packaged in unit dose, rolls, bulk bottles, blister packs and combinations thereof, without limitation.
  • composition of the following formulation was prepared in gel-cap form, including the appropriate excipients, by standard methods known to those of ordinary skill in the art:
  • Vitamin A (Beta Carotene) 1100 IU Vitamin C 30 mg Vitamin D (Vitamin D3) 1000 IU Vitamin E 20 IU Vitamin B1 1.6 mg Vitamin B2 (Riboflavin) 1.8 mg Vitamin B3 (Niacinamide) 15 mg Vitamin B6 2.5 mg Vitamin B9 (Folic Acid) 1 mg Vitamin B12 12 ⁇ g Iron 29 mg Magnesium 20 mg Zinc 25 mg Copper 2.0 mg Iodine 150 ⁇ g DHA 200 mg
  • compositions may be incorporated into multiple compositions as a kit.
  • a first composition of the following formulation is prepared in caplet form, including the appropriate excipients, by standard methods known to those of ordinary skill in the art:
  • Vitamin A (Beta Carotene) 1100 IU Vitamin C 30 mg Vitamin D (Vitamin D3) 1000 IU Vitamin E 20 IU Vitamin B1 1.6 mg Vitamin B2 (Riboflavin) 1.8 mg Vitamin B3 (Niacinamide) 15 mg Vitamin B6 2.5 mg Vitamin B9 (Folic Acid) 1 mg Vitamin B12 12 ⁇ g Iron 29 mg Magnesium 20 mg Zinc 25 mg Copper 2.0 mg Iodine 150 ⁇ g
  • a second composition of the following formulation is prepared in gel-cap form by standard methods known to those of ordinary skill in the art:
  • various active ingredients may be divided into multiple compositions or a kit.
  • the active ingredients of the composition of Example 1 may be divided into multiple compositions or kits.
  • a first composition of the following formulation is prepared in gel-cap form, including the appropriate excipients, by standard methods known to those of ordinary skill in the art:
  • Vitamin A (Beta Carotene) 550 IU Vitamin C 15 mg Vitamin D (Vitamin D3) 500 IU Vitamin E 10 IU Vitamin B1 0.8 mg Vitamin B2 (Riboflavin) 0.9 mg Vitamin B3 (Niacinamide) 7.5 mg Vitamin B6 1.25 mg Vitamin B9 (Folic Acid) 0.5 mg Vitamin B12 6.0 ⁇ g Iron 14.5 mg Magnesium 10 mg Zinc 12.5 mg Copper 1.0 mg Iodine 75 ⁇ g DHA 100 mg
  • a second composition of the following formulation is prepared in gel-cap form by standard methods known to those of ordinary skill in the art:
  • Vitamin A (Beta Carotene) 550 IU Vitamin C 15 mg Vitamin D (Vitamin D3) 500 IU Vitamin E 10 IU Vitamin B1 0.8 mg Vitamin B2 (Riboflavin) 0.9 mg Vitamin B3 (Niacinamide) 7.5 mg Vitamin B6 1.25 mg Vitamin B9 (Folic Acid) 0.5 mg Vitamin B12 6.0 ⁇ g Iron 14.5 mg Magnesium 10 mg Zinc 12.5 mg Copper 1.0 mg Iodine 75 ⁇ g DHA 100 mg
  • a study is undertaken to evaluate the effectiveness of the compositions of the present invention in the treatment of patients.
  • the objective of the study is to determine whether oral intake of the compositions results in an improvement of the nutritional status of patients with regard to the specific vitamins and minerals contained in the administered compositions.
  • a double-blind, placebo controlled study is conducted over a six-month period.
  • a total of 120 subjects 60 pregnant women entering the second trimester of pregnancy and 60 lactating women), aged 20-35 years, are chosen for the study.
  • An initial assessment of the nutritional status of each woman is conducted.
  • Vitamin A and vitamin B6 are measured using high performance liquid chromatography.
  • Erythrocyte transketolase activity is used to measure vitamin B1 levels.
  • Vitamin B2 levels are determined by assessment of erythrocyte glutathione reductase activity.
  • Vitamin B3 levels are assessed by measuring urinary excretion of N′methylnicotinamide and its pyridone.
  • Vitamin B9 is measured by radioimmunoassay (RIA), specifically The Solid Phase No Biol Folic Acid Kit (Diagnostic Products, Los Angeles, Calif.). Vitamin B12 is measured by RIA using human intrinsic factor as a binder. Vitamin C levels are measured by spectrophotometric and colorimetric methods. Vitamin D is measured using an extraction double-antibody RIA (Dia Sorin, Inc., Stillwater, Minn.). The peroxide hemolysis test is used to determine vitamin E status. Iron levels are measured using standard spectrophotometry. Iodine levels are measured by HPLC. Magnesium levels are measured by absorbance of a magnesium chelate with xylidl blue at 660 nM. Zinc levels are assessed using flame atomic absorption spectrometry (Perkins Elmer 460, Norwalk, Conn.). DHA is measured and quantified using gas chromatography procedures.
  • RIA radioimmunoassay
  • total serum homocysteine levels are determined by extraction on the Multi-Prep® gravity series GVSA-100 column, a strong anion exchange gravity flow column, and measurement by gas chromatography/mass spectrometry. Biochemical Diagnostics, Austin, Tex.
  • the 120 subjects are separated into four separate groups of 30 women.
  • each subject is administered one dosage form of the composition as described in Example 1 once a day.
  • each subject is administered one placebo dosage form once a day.
  • dosage form administration occurs every 24 hours. No other nutritional supplements are taken by the subjects during the assessment period.
  • Detection of the temporal onset of effects is done sequentially by testing for the presence of significant treatment effects at 1, 2, 3, 4, 5, and 6 months, proceeding to the earlier time in sequence only when significant effects have been identified at each later time period. Changes from the baseline within each group are evaluated using paired t-tests. In addition, analysis of variance is performed on all baseline measurements and measurable subject characteristics to assess homogeneity between groups. All statistical procedures are conducted using the Statistical Analysis System (SAS Institute Inc., Cary, N.C.). An alpha level of 0.05 is used in all statistical tests.
  • a study is undertaken testing supplementation of iodine, and vitamin D.
  • a study is conducted over a three-month period.
  • a total of 120 subjects pregnant women entering the second trimester of, aged 20-35 years, are chosen for the study.
  • An initial assessment of the nutritional status of each woman for iodine, and vitamin D is conducted as provided in Example 4.
  • each subject is administered 1 gelcap daily, with the composition as described in Example 1.
  • each subject is administered 1 one caplet daily that includes the following ingredients in the listed amounts (control):
  • Vitamin A (acetate) 1100 IU Beta Carotene 600 IU Vitamin B 1 (thiamine mononitrate) 1.6 mg Vitamin B 2 (riboflavin) 1.8 mg Vitamin B 3 (niacinamide) 15 mg Vitamin B 6 (pyridoxine hydrochloride) 2.5 mg Vitamin B 9 (folic acid) 1000 ⁇ g Vitamin B 12 (cyanocobalamin) 5 ⁇ g Vitamin C (ascorbic acid) 60 mg Vitamin D (cholecalciferol) 400 IU Vitamin E (d-alpha-tocopheryl acetate) 30 IU Iron (polysaccharide complex) 29 mg Magnesium (magnesium oxide) 25 mg Zinc (zinc oxide) 15 mg
  • An assessment of nutritional status for each subject is measured at one-month intervals for a six month period. Specifically, in regard to vitamin D deficiency, the serum levels of 25-hydroxyvitamin D are measured to assess if they meet levels as high as 30 ng/ml or are increasing towards a level of 30 ng/ml. The data is evaluated using multiple linear regression analysis and a standard students t-test. In each analysis the baseline value of the outcome variable is included in the model as a covariant. Treatment by covariant interaction effects is tested by the method outlined by Weigel & Narvaez, 12 C ONTROLLED C LINICAL T RIALS 378-94 (1991). If there are no significant interaction effects, the interaction terms are removed from the model.
  • the regression model assumptions of normality and homogeneity of variance of residuals are evaluated by inspection of the plots of residuals versus predicted values. Detection of the temporal onset of effects is done sequentially by testing for the presence of significant treatment effects at 16, 12, and 8 weeks, proceeding to the earlier time in sequence only when significant effects have been identified at each later time period. Changes from the baseline within each group are evaluated using paired t-tests. In addition, analysis of variance is performed on all baseline measurements and measurable subject characteristics to assess homogeneity between groups. All statistical procedures are conducted using the Statistical Analysis System (SAS Institute Inc., Cary, N.C.). An alpha level of 0.05 is used in all statistical tests.
  • a statistically significant improvement in the nutritional status is preferably observed in the treated subjects who were administered the composition of Example 1 over treated subjects who are administered the controls.
  • the tested serum levels of 25-hydroxyvitamin D are preferably in the range of 30 ng/ml for treated subjects.
  • serum levels show an increased level of iodide levels; whereas the control shows not increased iodide serum level.

Abstract

The present invention relates to compositions, kits and methods for the administration of various vitamin, mineral and nutrient compositions, and in a specific embodiment, the compositions, kits and methods may utilize or include vitamin D, iodine, vitamin B1, vitamin B6, vitamin B12, vitamin B2, vitamin B9, vitamin B3, vitamin E, vitamin A, vitamin C, iron, zinc, copper, magnesium, omega 3 fatty acids and one or more pharmaceutically acceptable carriers.

Description

    CROSS REFERENCE TO RELATED APPLICATION
  • The present application is a continuation and claims the benefit, under 35 U.S.C. §120, of U.S. patent application Ser. No. 13/292,735, filed Nov. 9, 2011, which claims the benefit under 35 U.S.C. §119 of U.S. Provisional Patent Application Ser. No. 61/505,341, filed Jul. 7, 2011, the entire contents and substance of this application of which are hereby expressly incorporated by reference in their entirety.
  • FIELD OF THE INVENTION
  • The present invention relates to various vitamin, nutrient and mineral compositions and kits for nutritional supplementation and methods of administration of compositions and kits for nutritional supplementation in, for example, subjects in physiologically stressful states, such as occur during pregnancy, lactation, or in need thereof.
  • BACKGROUND OF THE INVENTION
  • Nutrition plays a critical role in maintaining good health. Proper nutrition prevents dietary deficiencies, and also protects against the development of disease. When the body faces physiological stress, proper nutrition plays an increasingly important role. For example, pregnancy and lactation are among the most nutritionally volatile and physiologically stressful periods and processes in the lifetimes of women. Vitamin and mineral needs are almost universally increased during these natural processes. Increased vitamin and mineral needs during these times are almost always due to elevated metabolic demand, increased plasma volume, increased levels of blood cells, decreased concentrations of nutrients, and decreased concentrations of nutrient-binding proteins.
  • When increased nutrient needs occur during pregnancy, lactation, or any other physiologically stressful state, nutritional supplementation serves a vital role in maintaining good health. Nutritional supplementation is especially pertinent to women contemplating conceiving a child because optimizing specific nutrients before, during, and after the physiological processes of pregnancy or lactation can have profound, positive, and comprehensive impacts upon the overall wellness of the developing and newborn child as well as on the safety and health of the mother. The present invention provides compositions, kits and methods designed to supplement the nutritional needs of individuals in physiologically stressful states.
  • Supplementation with certain vitamins and minerals serves a role in protecting against disease and contributes to the overall health of the mother and developing child. Specifically, vitamins, nutrients and minerals such as vitamin D, iodine, vitamin B1, vitamin B6, vitamin B12, vitamin B2, vitamin B9, vitamin B3, vitamin E, vitamin A, vitamin C, iron, zinc, copper, magnesium, and omega 3 fatty acids such as docosahexaenoic acid (DHA), play integral roles in physiological mechanisms that serve to prevent, treat and/or alleviate the occurrence or negative effects of some diseases.
  • Iodine also provides nutritional benefits as it is an essential component of the thyroid hormones that are involved in the regulation of various enzymes and metabolic processes, such as thyroxine and triiodothyronine. Indeed, iodine deficiency disorders (IDD) include mental retardation, hypothyroidism, goiter, cretinism, and varying degrees of other growth and developmental abnormalities which can be a result from inadequate thyroid hormone production from lack of sufficient iodine. See, for example, Food and Nutrition Board and Institute of Medicine, DIETARY REFERENCE INTAKES FOR VITAMIN A, VITAMIN K, ARSENIC, BORON, CHROMIUM, COPPER, IODINE, IRON, MANGANESE, MOLYBDENUM, NICKEL, SILICON, VANADIUM, AND ZINC (2001), page 260. Further, iodine is an important element in breast milk for infant nutrition. An adequate concentration of iodine in breast milk is essential to provide for optimal neonatal thyroid hormone stores and to prevent impaired neurological development in breast-fed neonates. In many countries of the world, low iodine content of the breast milk indicates less than optimum maternal and infant iodine nutrition. F. Azizi et al., CLIN ENDOCRINOL, 70(5):803-9 (2009). Multivitamin and multi nutritional supplements, for example for prenatal pregnant or breast-feeding women, are also lacking or deficient in the dosage amount of this important mineral.
  • In another example, there is a need for a nutritional supplement with increased vitamin D, in for example, a prenatal or dietary supplement, as recent research suggests that vitamin D has more positive physiological effects than previous thought, in for example prenatal and pregnant women. It has recently been determined that vitamin D has previously unknown roles in the enhancement of vascular function, defense against cancer, immuno-competence, blood pressure regulation and possessing the ability to enhance cellular insulin sensitivity in the human body. Due to the additional roles that vitamin D plays in the human body, it has recently been determined that higher daily vitamin D intake beyond current recommendations may be associated with better health outcomes. Indeed, studies suggest increasing the serum level of 25-hydroxyvitamin D, a beneficial derivative of vitamin D, to a 30 ng/ml serum range. A 30 ng/ml appears to be the most advantageous serum level in recent studies reviewing patient bone mineral density (BMD), lower extremity function, dental health, risk of falls, admission to nursing home, fractures, cancer prevention and incident hypertension. Bischoff-Ferrari H A, ADV EXP MED BIOL. 624:55-71 (2008). Effective and safe doses of vitamin D to bring serum levels of 25-hydroxyvitamin D up to a desirable level of 30 ng/ml is currently needed.
  • Lastly, a present problem with nutritional supplements that include multiple vitamins, nutrients and minerals is the ability to include all the components in one composition. Providing a single composition multivitamin and multinutrient supplement is an appealing feature because it improves patient compliance. Patients, and specifically for example, pregnant patients, often have nausea, and may have difficulty swallowing nutritional supplements. Compliance issues regarding taking multiple pills may therefore result. A one pill or one composition nutritional supplement that includes the beneficial vitamins, nutrients and minerals in appropriate dosage amongst would thus be beneficial for improving patient compliance in for example, pregnant women. A difficulty in the nutrition supplement market, however, is the ability to include multiple vitamins, minerals and nutrients of various water or fat solubilities in the needed dosage amounts all in one composition. For example, nutritional supplements that include fat soluble compounds such as DHA and water soluble vitamins such as B-complex vitamins and vitamin C, are often separated into multiple compositions. A supplement comprising multiple vitamins, nutrients and minerals blended to form a single composition, is thus currently needed. In a specific example, the single composition may be in the form of a gelcap. Patient compliance is also improved if a gelcap is used to administer the drug because of its soft and elastic nature, which makes it easier to swallow compared to a hard tablet or caplet.
  • A liquid gelcap also has numerous advantages. First, it retains many of the advantages of consumer acceptance and is easier to swallow due to the outer coating being a soft and elastic gelatin shell. Also, concentrated liquid compositions are well suited for encapsulation within a soft gelatin shell, creating flexibility that further assists in the capsule being easier to swallow. The active drug contained in the liquid form also provides advantages by dispersing the drug to the active site. For example, the active drug does not first have to dissolve in the gastrointestinal tract, thereby facilitating absorption of the pharmacologically active substance. See, for example, U.S. Pat. No. 6,689,382, which is expressly incorporated by reference herein. Other formulations take advantage of the liquid form by creating a sustained release gelatin capsule, thereby permitting the delivery of the drug in a controlled fashion. See, for example, U.S. Pat. Nos. 5,324,280 and 6,929,803, which are expressly incorporated by reference herein.
  • SUMMARY OF THE INVENTION
  • The present invention provides compositions and methods of administering compositions for both prophylactic and therapeutic nutritional supplementation. Specifically, for example, the present invention relates to novel compositions of vitamins, minerals, and omega-3 fatty acids that can be used to supplement the nutritional deficiencies observed in patients throughout physiologically stressful states, which, in certain embodiments of the present invention, include prenatal, pregnant and breast-feeding women.
  • One embodiment of the present invention may include a nutritional supplement wherein multiple vitamins, minerals and nutrients are provided in one composition. In one embodiment of the present invention, the composition may comprise vitamin D, iodine, vitamin B1, vitamin B6, vitamin B12, vitamin B2, vitamin B9, vitamin B3, vitamin E, vitamin A, vitamin C, iron, zinc, copper, magnesium, omega 3 fatty acids and one or more pharmaceutically acceptable carriers.
  • In one embodiment of the present invention, vitamin D may be included in the form selected from one or more of the group consisting of vitamin D3 (calciol or cholecalciferol or colecalciferol), vitamin D2 (calciferol, ergocalciol, ergocalciferol, ercalciol, Deltalin or Viosterol), previtamin D2, ergosterol, calcitriol (1,25-dihydroxycholecalciferol), 7-dehydrocholesterol, vitamin D1, vitamin D4 (also known as 22-dihydroergocalciferol, 22,23-dihydroercalciol or (24S)-methylcalciol), vitamin D5 (also known as (24S)-Ethylcalciol or sitocalciferol), 7-dehydrositosterol, Lumisterol, 25-hydroxyvitamin D, all steroids that exhibit the biological activity of calciol, 25-fluorocalciol, (3S)-3-amino-3-deoxycalciol, 11α-acetoxycalciol, calcidiol (25-hydroxycholecalciferol or calcifediol), ercalcitriol, calcitetrol, tacalciol (tachysterol3), (5E)-isocalciol (isovitamin D3), Dihydroercalciol (dihydrotachysterol3), (1S)-Hydroxycalciol (also known as 1α-hydroxycholecalciferol or alfacaleidol), (24R)-Hydroxycalcidiol (also known as 24(R),25-dihydroxycholecalciferol), Ercalcidiol, Ercalcitriol, Ertacalciol, (5E)-(10S)-10,19-Dihydroercalciol (dihydrotachysterol2), (6Z)-Tacalciol (precalciferol or pre-vitamin D), and (22E)-(24R)-Ethyl-22,23-didehydrocalciol (vitamin D6).
  • In another embodiment, the compositions may include vitamin B1 in the form selected from one or more of the group consisting of thiamine, thiamine monophosphate, thiamine diphosphate, thiamine triphosphate, acetiamine, allithiamine, prosultiamine and S-acyl derivatives of thiamine such as benfotiamine, fursultiamine and salts and esters thereof. In another embodiment, the compositions may include vitamin B1 in the form selected from one or more of the group consisting of thiamine, thiamine monophosphate, thiamine diphosphate, thiamine triphosphate, acetiamine, allithiamine, prosultiamine and S-acyl derivatives of thiamine such as benfotiamine, fursultiamine and salts and esters thereof.
  • In another embodiment, the compositions may include vitamin A in the form selected from one or more of the group consisting of retinol acetate (retinyl acetate or vitamin A acetate), retinol (vitamin A alcohol), retinol palmitate (retinyl palmitate or vitamin A palmitate), retinoic acid (tretinoin), retinal, beta-cryptoxanthin, alpha-carotene, beta-carotene, gamma-carotene, and provitamin A carotenoids. In a specific embodiment, vitamin A may be included in the form of beta carotene.
  • In another embodiment, the compositions may include vitamin B9 in the form selected from one or more of the group consisting of folic acid, folinic acid, folacin, metafolin, and/or one or more natural isomers of folate including (6S)-tetrahydrofolic acid or a polyglutamyl derivative thereof, (6S,R)-tetrahydrofolic acid or a polyglutamyl derivative thereof, 5-methyl-(6S)-tetrahydrofolic acid or a polyglutamyl derivative thereof, 5-methyl-(6S,R)-tetrahydrofolic acid or a polyglutamyl derivative thereof, 5-formyl-(6S)-tetrahydrofolic acid or a polyglutamyl derivative thereof, 10-formyl-(6R)-tetrahydrofolic acid or a polyglutamyl derivative thereof, 5,10-methylene-(6R)-tetrahydrofolic acid or a polyglutamyl derivative thereof, 5,10-methenyl-(6R)-tetrahydrofolic acid or a polyglutamyl derivative thereof and 5-formimino-(6S)-tetrahydrofolic acid or a polyglutamyl derivative thereof and their salts and esters thereof. In another embodiment, the compositions may include vitamin B2 in the form selected from one or more of the group consisting of flavin mononucleotide (FMN), flavin adenine dinucleotide (FAD), riboflavin (also known as 7,8-dimethyl-10-((2R,3R,4S)-2,3,4,5-tetrahydroxypentyl)benzo[g]pteridine-2,4 (3H,10H)-dione or lactoflavin) and riboflavin derivatives such as riboflavin-5′-monophosphate, riboflavin-5′-monobutyrate and riboflavin-5′-monopalmitate.
  • In another embodiment, the compositions may include vitamin B3 in the form selected from one or more of the group consisting of niacin (nicotinic acid or pyridine-3-carboxylic acid), and nicotinamide (niacinamide) and salts and esters thereof. In another embodiment, the compositions may include vitamin B6 in the form selected from one or more of the group consisting of pyridoxine, 3-hydroxy-4,5-bis(hydroxymethyl)-2-methylpyridine, 5′-deoxypyridoxal, 2-demethylpyridoxal(2-norpyridoxal), 2-propyl-2-norpyridoxal (2′-ethylpyridoxal), 6-methylpyridoxal, 2′-hydroxypyridoxal (2-hydroxymethyl-2-demethylpyridoxal or 2-hydroxymethyl-2-norpyridoxal), 4′-deoxypyridoxine 5′-phosphate, 5′-methylpyridoxal-5′-phosphate, pyridoxal N-oxide 5′-phosphate, Pyridoxal, Pyridoxamine, Pyridoxine-5′-phosphate (PNP), pyridoxal-5′-phosphate (PLP) and pyridoxamine-5′-phosphate (PMP), and their salts and chelates thereof. In another embodiment, the compositions may include vitamin B12 in the form selected from one or more of the group consisting of cobalamin, methylcobalamin, 5′-deoxyadenosylcobalamin (adenosylcobalamin or cobamamide), cyanocobalamin, hydroxycobalamin and mecobalamin.
  • In another embodiment, the compositions may include vitamin E in the form selected from one or more of the group consisting of alpha, beta, gamma, and delta tocopherols in its natural or synthetic (dl) forms; alpha, beta, gamma, and delta tocotrienols in its natural or synthetic (dl) forms, dl-alpha tocopheryl derivatives such as dl-alpha tocopheryl esters, dl-alpha-tocopheryl acetate or succinate and d-alpha-tocopheryl acetate or dl-alpha tocopheryl phosphates (such as Ester-E®). In another embodiment, the compositions may include vitamin C in the form selected from one or more of the group consisting of ascorbic acid, ascorbates (calcium or sodium ascorbate), dehydroascorbic acid and salts, ascorbyl palmitate, ascorbyl phosphates and salts (such as sodium or magnesium ascorbyl phosphate), ascorbyl tetraisopalmitate, tetrahexyldecyl ascorbate, ascorbyl sulfates and salts, acylated ascorbic acid derivatives (such as 6-O-acyl-2-O-alpha-D-glucopyranosyl-L-ascorbic acids), 6-bromo-6-deoxy-L-ascorbic acid, and ascorbate salts. In another embodiment, the compositions may include iron in the form selected from one or more of the group consisting of elemental iron, in the form of a salt, chelated form, non-chelated form, chelated to an amino acid, carbonyl iron, ferrous gluconate, ferrous fumarate, polysaccharide iron complex, elemental polysaccharide iron, polysaccharide iron, ferrous (II)-bis-glycinate chelate, ferrous asparto glycinate, ferrous bisglycinate, ferrous bisglycinate hydrochloride, ferrous bisglycinate, elemental ferrous bisglycinate, ferrous sulfate, ferronyl (micronized), as Iron Aid, iron protein succinylate, carbonyl iron, Sumalate iron, Heme iron complex, as Ferrochel amino acid chelate, Heme iron polypeptide as Proferrin-bovine source, as heme iron polypeptide (bovine source) as sodium iron EDTA (Ferrazone), ferric ammonium citrate, elemental iron, and ferric pyrophosphate.
  • In another embodiment, the compositions may include zinc in the form selected from one or more of the group consisting of elemental zinc, in the form of a salt, in a chelated form, in a non-chelated form, zinc acetate, zinc gluconate, zinc picolinate, zinc sulfate and zinc oxide. In another embodiment, the compositions may include copper in the form selected from one or more of the group consisting of elemental copper, in the form of a salt, in a chelated form, in a non-chelated form, cupric oxide, copper sulfate, copper gluconate, copper citrate, cupric acetate, alkaline copper carbonate, and copper salicylate. In another embodiment, the compositions may include magnesium in the form selected from one or more of the group consisting of elemental magnesium, in the form of a salt, in a chelated form, in a non-chelated form, magnesium acetate, magnesium carbonate, magnesium gluconate, magnesium chloride, magnesium citrate, magnesium silicate, magnesium stearate, magnesium sulfate, magnesium oxide, and magnesium chelated to an amino acid (magnesium glycinate, magnesium aspartate).
  • In another embodiment, the compositions may include omega 3 fatty acids in the form selected from one or more of the group consisting docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA) and α-linolenic acid (ALA). In a specific embodiment of the present invention, omega-3 fatty acids may comprise DHA. In a specific embodiment, the source of DHA is algae oil. In one specific embodiment, the source of the algae oil is microalgae Crypthecodinium cohnii.
  • In another embodiment, the compositions may include iodine in the form selected from one or more of the group consisting of iodide, elemental iodine, iodized salt, Lugol's iodine, sodium iodide, potassium iodide, potassium iodate, nascent iodine, and Nano-Colloidal Detoxified Iodine.
  • In an embodiment, the compositions may include vitamin D in an amount of about 500 I.U. to about 1500 I.U., iodine in an amount of about 75 μg to about 225 μg, vitamin B1 in an amount of about 0.8 mg to about 2.4 mg, vitamin B6 in an amount of about 1.2 mg to about 3.8 mg, vitamin B12 in an amount of about 6 μg to about 18 μg, vitamin B2 in an amount of about 0.9 mg to about 2.7 mg, vitamin B9 in an amount of about 0.5 mg to about 1.5 mg, vitamin E in an amount of about 10 I.U. to about 30 I.U., vitamin A in an amount of about 550 I.U. to about 1650 I.U., vitamin C in an amount of about 15 mg to about 45 mg, vitamin B3 in an amount of about 7.5 mg to about 22.5 mg, iron in an amount of about 14.5 mg to about 43.5 mg, zinc in an amount of about 12.5 mg to about 37.5 mg, copper in an amount of about 1.0 mg to about 3.0 mg, magnesium in an amount of about 10 mg to about 30 mg, and omega 3 fatty acids in an amount of about 100 mg to about 300 mg.
  • In a specific embodiment, vitamin D may be in the form of vitamin D3 and may be present in an amount of about 1000 I.U. or 25 μg. In a specific embodiment, iodine may be present in an amount of about 150 μg. In a specific embodiment, vitamin B1 may be present in an amount of about 1.6 mg. In a specific embodiment, vitamin B6 may be present in an amount of about 2.5 mg. In a specific embodiment, vitamin B12 may be present in an amount of about 12 μg. In a specific embodiment, vitamin B2 may be present in an amount of about 1.8 mg. In a specific embodiment, vitamin B9 may be present in an amount of about 1.0 mg. In a specific embodiment, vitamin E may be present in an amount of about 20 I.U. In a specific embodiment, vitamin A may be in the form of beta carotene and present in an amount of about 1100 I.U. or about 660 μg. In a specific embodiment, vitamin C may be present in an amount of about 30 mg. In a specific embodiment, vitamin B3 may be in the form of nicotinamide and present in an amount of about 15 mg. In a specific embodiment, iron may be present in an amount of about 29 mg. In a specific embodiment, zinc may be present in an amount of about 25 mg. In a specific embodiment, copper may be present in an amount of about 2.0 mg. In a specific embodiment, magnesium may be present in an amount of about 20 mg. In a specific embodiment, omega-3 fatty comprises DHA, and DHA may be present in an amount of about 200 mg.
  • In one embodiment, the compositions may be provided in a gelcap dosage form. In a specific embodiment, the gelcap dosage form is a liquid gelcap dosage form.
  • One embodiment of the present invention may include providing vitamin, mineral, and omega-3 fatty acid supplementation to a patient in need thereof by administering compositions disclosed herein to the patient. In a specific embodiment, the patient may be a female human. In a specific embodiment, the compositions may be administered to the female human before pregnancy, during pregnancy, after pregnancy, while breast-feeding, or a combination thereof. In a specific embodiment, the compositions are administered once daily to the patient.
  • In a specific embodiment, the methods may comprise administering a composition comprising vitamin D in an amount of about 500 I.U. to about 1500 I.U., iodine in an amount of about 75 μg to about 225 μg, vitamin B1 in an amount of about 0.8 mg to about 2.4 mg, vitamin B6 in an amount of about 1.2 mg to about 3.8 mg, vitamin B12 in an amount of about 6 μg to about 18 μg, vitamin B2 in an amount of about 0.9 mg to about 2.7 mg, vitamin B9 an amount of about 0.5 mg to about 1.5 mg, vitamin E in an amount of about 10 I.U. to about 30 I.U., vitamin A in an amount of about 550 I.U. to about 1650 I.U., vitamin C in an amount of about 15 mg to about 45 mg, vitamin B3 in an amount of about 7.5 mg to about 22.5 mg, iron in an amount of about 14.5 mg to about 43.5 mg, zinc in an amount of about 12.5 mg to about 37.5 mg, copper in an amount of about 1.0 mg to about 3.0 mg, magnesium in an amount of about 10 mg to about 30 mg, and omega 3 fatty acids in an amount of about 100 mg to about 300 mg.
  • In another specific embodiment, the methods may comprise administering a composition comprising vitamin D in an amount of about 1000 I.U., iodine in an amount of about 150 μg, vitamin B1 in an amount of about 1.6 mg, vitamin B6 in an amount of about 2.5 mg, vitamin B12 in an amount of about 12 μg, vitamin B2 in an amount of about 1.8 mg, vitamin B9 in an amount of about 1.0 mg, vitamin E in an amount of about 20 I.U., vitamin A in an amount of about 1100 I.U., vitamin C in an amount of about 30 mg, vitamin B3 in an amount of about 15 mg, iron in an amount of about 29 mg, zinc in an amount of about 25 mg, copper in an amount of about 2.0 mg, magnesium in an amount of about 20 mg, and omega 3 fatty acids comprising DHA in an amount of about 200 mg.
  • DETAILED DESCRIPTION OF THE INVENTION
  • It is understood that the present invention is not limited to the particular methodologies, protocols, fillers, and excipients, etc., described herein, as these may vary. It is also to be understood that the terminology used herein is used for the purpose of describing particular embodiments only, and is not intended to limit the scope of the present invention. It must be noted that as used herein and in the appended claims, the singular forms “a,” “an,” and “the” include the plural reference unless the context clearly dictates otherwise. Thus, for example, a reference to “a vitamin” is a reference to one or more vitamins and includes equivalents thereof known to those skilled in the art and so forth.
  • Unless defined otherwise, all technical and scientific terms used herein have the same meanings as commonly understood by one of ordinary skill in the art to which this invention belongs. Specific methods, devices, and materials are described, although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention. All references cited herein are incorporated by reference herein in their entirety.
  • The term “disease state” as used herein, may comprise any state in which one or more organs or components of an organism malfunction. The term “disease state” may refer to any deterioration of any component of a patient's body and specifically a human patient's body. The term “disease state” may refer to any deficiency of any compound necessary for the maintenance or function of any component of any organism. The term “disease state” may refer to any condition in which a body contains toxins, produced by microorganisms that infect the body or by body cells through faulty metabolism or absorbed from an external source. “Disease states” may be adverse states caused by any diet, any virus, fungi or any bacteria. “Disease states” may comprise disorders associated with pregnant females such as, for example, osteomalacia and preeclampsia and disorders associated with a fetus such as, for example, neural tube defects and various fetal abnormalities. “Disease states” may comprise any pulmonary disorder such as, for example, bronchitis, bronchiectasis, atelectasis, pneumonia, diseases caused by inorganic dusts, diseases caused by organic dusts, any pulmonary fibrosis, and pleurisy. “Disease states” may comprise any hematological/oncological disorder such as, for example, anemia, hemophilia, leukemia, and lymphoma. A “disease state” may comprise any cancer such as, for example, breast cancer, lung cancer, prostate cancer, pancreatic cancer, liver cancer, stomach cancer, testicular cancer, ovarian cancer, skin cancer, cancer of the brain, cancer of the mouth, cancer of the throat, and cancer of the neck. “Disease states” may comprise any disorder of the immune system such as, for example, acquired immune deficiency syndrome (AIDS), AIDS-related complex, infection by any strain of any human immunodeficiency virus (HIV), and other viruses or pathogens such as bacteria, fungi and parasites. A “disease state” may comprise any cardiovascular disorder such as, for example, arterial hypertension, orthostatic hypotension, arteriosclerosis, coronary artery disease, cardiomyopathy, any arrhythmia, any valvular heart disease, endocarditis, pericardial disease, any cardiac tumor, any aneurysm, and any peripheral vascular disorder. “Disease states” may comprise any hepatic/biliary disorder such as, for example, jaundice, hepatic steatosis, fibrosis, cirrhosis, hepatitis, any hepatic granuloma, any liver tumor, cholelithiasis, cholecystitis, and choledocholithiasis. A “disease state” may include a viral infection such as from HIV, herpes virus (HSV-1 and HSV-2), the virus that causes vesicular stomatitis (VSV), measles virus, herpes viridae, human lymprotropic visusess, vesicular stomatitis virus, visna virus, cytomegalovirus, Epstein-Barr virus, influenza virus, pneumonovirus, Sarcoma virus, Syncitial virus and Rubeola virus. A “disease state” may include a fungal infection such as from Candida albicans and Giardia lamblia. A “disease state” may include a bacterial infection such as from Staphylococcus, Corynebacerium, Bacillus, Listeria and Streptococcus bacteria, and include species such as Staphylococcus aureus, bacillus anthracis, Helicobacter pylori and, Listeria monocytogenes, and Streptococcus agalactiae.
  • The term “patient,” as used herein, comprises any and all organisms and includes the term “subject.” “Patient” may refer to a human or any other animal. “Patient” may also refer to a fetus.
  • The phrase “co-administration” refers to administration of two or more compositions to a patient together, which includes administration at about the same time or within a certain specific or desired time.
  • The phrase “chewable form” refers to any relatively soft compositions that are chewed in the mouth after oral administration, may have a pleasant taste and mouthfeel, and may quickly break into smaller pieces and may begin to dissolve after chewing such that they can be swallowed substantially as a solution.
  • The phrase “dissolvable form” refers to any compositions that dissolve into a solution in the mouth. Such compositions, in one embodiment, may dissolve within about 60 seconds or less after placement in the mouth without any chewing.
  • The term “mouthfeel” refers to non-taste-related aspects of the pleasantness experienced by a person while chewing or swallowing a nutritional supplement. Aspects of mouthfeel include, for example and without limitation, the hardness and brittleness of a composition, whether the composition is chewy, gritty, oily, creamy, watery, sticky, easily dissolved, astringent, effervescent, and the like, and the size, shape, and form of the composition (tablet, powder, gel, etc.).
  • The phrase “pharmaceutically acceptable,” as used herein, refers to those compounds, materials, compositions and/or dosage forms which are, within the scope of sound pharmaceutical/medical judgment, suitable for use in contact with the tissues of human beings and animals without excessive toxicity, irritation, allergic response, or other problem or complication, commensurate with a reasonable benefit/risk ratio. Thus, the phrase “pharmaceutically acceptable carriers,” as used herein, refers to such suitable compounds and materials defined above that may be added to the dosage form to assist in satisfactory processing of the dosage form or provide desirable physical characteristics to the dosage form. For example, “pharmaceutically acceptable carriers” may include, but is not limited to, binders, diluents, lubricants, glidants, colorants, emulsifiers, disintegrants, starches, water, oils, alcohols, preservatives, and sugars. In another example, “pharmaceutically acceptable carriers” refers to dosage forms such as capsules, caplets, gel-caps used with, for example, the compositions of the present invention comprising or consisting of omega-3 fatty acids such as docosahexaenoic acid (DHA). Thus, “pharmaceutically acceptable carriers” in gel-caps may be in for example, liquid or oil form, and may include a filler or other appropriate liquid vehicle and may be used with omega-3 fatty acids such as docosahexaenoic acid (DHA) and their equivalents.
  • The phrase “swallowable form” refers to any compositions that typically do not or are not configured to readily dissolve when placed in the mouth and may be swallowed whole, preferably without any, or with minimal, chewing or discomfort. Such compositions, in one embodiment, may have a shape containing no sharp edges and a smooth, uniform and substantially bubble free outer coating.
  • The term “dosage form,” as used herein, is the form in which the dose is to be administered to the subject or patient. The drug or supplement is generally administered as part of a formulation that includes nonmedical agents. The dosage form has unique physical and pharmaceutical characteristics. Dosage forms, for example, may be solid, liquid or gaseous. “Dosage forms,” may include for example, a capsule, tablet, caplet, gel caplet (gelcap), syrup, a liquid composition, a powder, a concentrated powder, a concentrated powder admixed with a liquid, a chewable form, a swallowable form, a dissolvable form, an effervescent, a granulated form, and an oral liquid solution. In a specific embodiment, the dosage form may be a gelcap.
  • The term “substantially free of added” as used herein, means free from therapeutically effective amounts of compounds when administered in suggested doses, but may include trace amounts of compounds in non-therapeutically effective amounts. For example, a composition of the present invention that included an inactive ingredient that is a salt or compound including a mineral would still be substantially free of added minerals. For example, trace amounts of titanium dioxide may be provided. Titanium dioxide which is an effective opacifier in powder form, where it is employed as a pigment to provide whiteness and opacity to numerous pharmaceutical products.
  • As used herein, the terms “inactive,” “inert,” “excipient,” and/or “formulatory” refer to any compound that is an inactive ingredient of a described composition. The definition of “inactive ingredient” as used herein follows that of the U.S. Food and Drug Administration, as defined in 21 C.F.R. 201.3(b)(8), which is any component of a drug product other than the active ingredient.
  • By “active ingredient,” then, includes any compound intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment and/or prevention of disease or a condition. See 21 C.F.R. 210.3(b)(7). Further, “active ingredients” include those compounds of the composition that may undergo chemical change during the manufacture of the composition and be present in the final composition in a modified form intended to furnish an activity or effect. Id. These include the vitamins, minerals and nutrients of the compositions and kits of the present invention.
  • The term “administrable” defines a composition that is able to be given to a patient. Likewise, “administering” refers to the act of giving a composition to a patient or otherwise making such composition available to a patient or the patient taking a composition.
  • As used herein, the term “about,” when located before a dosage amount or dosage range of a specific ingredient, refers to an amount or range closely above and/or closely below the stated amount or range that does not manifestly alter the therapeutic effect of the specific ingredient from the stated amount or range and is meant to encompass at least all equivalents of that amount.
  • The term “prenatal” supplementation includes optimizing specific nutrients before, during, and after the physiological processes of pregnancy and lactation, which can have profound, positive, and comprehensive impacts on the overall wellness of the developing and newborn child as well as on the safety and health of the mother.
  • Proper nutrition is essential for maintaining health and preventing diseases. Adequate nutrition is especially critical during, for example, nutritionally volatile or physiologically stressful periods such as those including, by way of example and without limitation, pregnancy, lactation, or any disease state. Vitamin and mineral needs are almost universally increased throughout these periods. Increased needs during physiologically stressful states such as pregnancy, lactation or disease state may result from elevated metabolic demand, increased plasma volume, increased quantities of circulating red blood cells, decreased concentrations of nutrients, and decreased concentrations of nutrient-binding proteins such as, for example and without limitation, serum-ferritin, maltose-binding protein, lactoferrin, calmodulin, tocopheryl binding protein, riboflavin binding protein, retinol binding protein, transthyretin, high density lipoprotein-apolipoprotein A1, folic acid binding protein, and 25-hydroxyvitamin D binding protein. Lapido, 72 (Supp.) AMER. J. CLIN. NUTR. 280S-90S (2000). Optimizing specific nutrients before, during, and after the physiological processes of pregnancy and lactation can have profound, positive, and comprehensive impacts on the overall wellness of the developing and newborn child as well as on the safety and health of the mother. Black, 85 (Supp.) BRIT. J. NUTR. S193-97 (2001); Scholl et al., 146 AMER. J. EPIDEM. 134-41 (1997). Nutrients provided to a mother reach the fetus. Specifically, it is established that substrates for growth and development, for example, circulate within the same pathways that carry drugs to and waste products from the fetus. Exchanges of material between mother and fetus occur primarily in the placenta, where villi containing fetal capillaries protrude into sinuses (intervillous spaces). Maternal arterial blood spurts into these spaces, then drains into maternal uterine veins to be returned to the maternal systemic circulation. Solutes in maternal blood cross the epithelial cells and connective tissue of the villi and the endothelium of the fetal capillaries; these solutes are then carried to the fetus by placental veins, which converge into the umbilical vein. THE MERCK MANUAL OF DIAGNOSIS AND THERAPY, (Mark H. Beers, M.D. et al., 18th ed. 2006). The, compositions, kits and methods of the present invention may thus provide the means to optimize good health by utilizing vitamin, mineral, and nutritional supplementation. The compositions, kits and methods of the present invention may be administered to or directed to a subject such as a human or any other organism.
  • The compositions, kits and methods of the present invention may include vitamin A. Vitamin A is involved in physiological processes that result in cellular differentiation, cellular maturity, and cellular specificity. Thus, vitamin A is an important component of a nutritional supplement for subjects in physiologically stressful states, such as those caused by pregnancy, lactation or disease state. Zile et al., 131(3) J. NUTR. 705-08 (2001). Care should be taken, however, to avoid excess. Indeed, supplemental vitamin A ingestion during pregnancy has been shown in some studies to be teratogenic or deforming to human and animal embryos. GB Mulder et al., 62(4) TERATOLOGY 214-26 (2000). In one embodiment of the present invention, vitamin A may be in a form that is a precursor (pro-vitamin) or metabolite of vitamin A that provides similar nutritional value as vitamin A. For example, the pro-vitamin A carotenoid, may be beta carotene. Beta carotene is converted to other forms of vitamin A, specifically retinol, within the body as needed, thereby avoiding the risk of retinol toxicity. Mayne, FASEB J 10:690-701 (1996). In a specific embodiment, vitamin A may be in one or more of the forms of retinol acetate (also known as retinyl acetate or vitamin A acetate), retinol (vitamin A alcohol), retinol palmitate (also known as retinyl palmitate or vitamin A palmitate), retinoic acid (tretinoin), retinal, beta-cryptoxanthin, alpha-carotene, beta-carotene, gamma-carotene, and provitamin A carotenoids.
  • In a specific embodiment, vitamin A may be in the form of beta carotene as beta carotene also has powerful anti-oxidant properties. Antioxidants are important during physiologically stressful events for numerous reasons. For example, lipid peroxidation has been associated with over 200 disease processes. Rock et al., 96(7) J. AMER. DIET. ASSOC. 693-702 (1996). Antioxidants are especially important during pregnancy because in the first trimester, establishment of blood flow into the intervillous space is associated with a burst of oxidative stress. The inability to mount an effective antioxidant defense against this burst results in early pregnancy loss. Myatt & Cui, 122, HISTOCHEM. CELL BIOL., 369-82 (2004). Further, oxidative stress has been implicated in the pathophysiology of preeclampsia, a toxemia of pregnancy. Llurba et al., 37(4) FREE RADIC. BIOL. MED. 557-70 (2004). Finally, oxidative stress during pregnancy plays an important role in fetal growth, and healthy antioxidant levels are positively correlated with birth weight and length. Myatt & Cui; Lee et al., 58 EUR. J. CUL. NUTR., 481-87 (2004).
  • In a specific embodiment of the compositions, kits and methods of the present invention, vitamin A may be included in amounts ranging from about 550 IU to about 1650 IU. In another specific embodiment, vitamin A may be included in amounts ranging from about 880 IU to about 1320 IU. In another specific embodiment, vitamin A may be included in amounts ranging from about 990 IU to about 1210 IU. In another embodiment, vitamin A may be included in an amount of about 1100 IU.
  • In another specific embodiment, vitamin A may be included in specific ranges or amounts for each specific form. When provided in their specific forms, the provided numerical range or amount includes the amounts of the specific form and/or compounds that are equivalent to the specific form. For example, vitamin A may be in the form of beta carotene and may be included in the amount of about 1100 IU. Accordingly, in this example, “beta carotene in the amount of about 1100 IU” would include 1000 IU of beta carotene and/or its equivalents and would, for example, include a product having 1100 IU retinol acetate instead of beta carotene.
  • In another specific embodiment of the compositions, kits and methods of the present invention, vitamin A in the form of beta carotene may be included in amounts ranging from about 550 IU to about 1650 IU. In another specific embodiment, vitamin A in the form of beta carotene may be included in amounts ranging from about 880 IU to about 1320 IU. In another specific embodiment, vitamin A in the form of beta carotene may be included in amounts ranging from about 990 IU to about 1210 IU. In another embodiment, vitamin A in the form of beta carotene may be included in an amount of about 1100 IU. In another specific embodiment of the compositions, kits and methods of the present invention, vitamin A may be included in the form of beta carotene and one or more forms of vitamin A. In a specific embodiment, the compositions, kits and methods of the present invention may include beta carotene and retinol. In another embodiment, the compositions, kits and methods of the present invention may include beta carotene and retinol acetate.
  • In another embodiment, vitamin A may be present in an amount determined by a measure of mass, as opposed to International Units. One International Unit (IU) of vitamin A is defined as the biological equivalent of about 0.6 μg of beta carotene, or about 0.3 μg of retinol. See REMINGTON, THE SCIENCE AND PRACTICE OF PHARMACY, page 1804(20th ed 2000). Accordingly, 550 IU to about 1650 IU is the biological equivalent of about 330 μg to about 990 μg. In another example, about 880 IU to about 1320 IU is the biological equivalent of about 528 μg to about 792 μg. In another example, about 990 IU to about 1210 IU is the biological equivalent of about 594 μg to about 726 μg. In another example, 1100 IU is the biological equivalent of about 660 μg.
  • The compositions, kits and methods of the present invention may comprise or use one or more B-complex vitamins. This class of vitamins comprises water-soluble nutrients generally not stored in the body. They play roles in a variety of biological processes critical to the health of pregnant women, lactating women, and fetuses such as, for example, the metabolism of homocysteine. The B-complex vitamins that may be included in the compositions, kits and methods of the present invention comprise one or more of vitamin B1, vitamin B2, vitamin B3, vitamin B6, vitamin B9 and vitamin B12.
  • The compositions, kits and methods of the present invention may comprise or use vitamin B1. Vitamin B1 plays a role in carbohydrate metabolism and neural function. It is a coenzyme for the oxidative decarboxylation of alpha-ketoacids (e.g., alpha-ketoglutarate and pyruvate) and for transketolase, which is a component of the pentose phosphate pathway. NATIONAL RESEARCH COUNCIL, RECOMMENDED DIETARY ALLOWANCES, page 125 (10th ed. 1989) (hereinafter “RDA”). In another specific embodiment, vitamin B1 may be in one or more of the forms of thiamine, thiamine monophosphate, thiamine diphosphate, thiamine triphosphate, acetiamine, allithiamine, prosultiamine and S-acyl derivatives of thiamine such as benfotiamine, fursultiamine and salts and esters thereof.
  • In another specific embodiment, vitamin B1 may be included in amounts ranging from about 0.8 mg to about 2.4 mg. In another specific embodiment, vitamin B1 may be included in amounts ranging from about 1.3 mg to about 1.9 mg. In another specific embodiment, vitamin B1 may be included in amounts ranging from about 1.4 mg to about 1.75 mg. In another embodiment, vitamin B1 may be included in an amount of about 1.6 mg.
  • In another specific embodiment, vitamin B1 may be included in specific ranges or amounts for each specific form. When provided in their specific forms, the provided numerical range or amount includes the amounts of the specific form and/or compounds that are equivalent to the specific form. For example, vitamin B1 may be in the form of thiamine mononitrate and may be included in the amount of about 1.6 mg. Accordingly, in this example, “thiamine mononitrate in the amount of about 1.6 mg” would include 1.6 mg of thiamine mononitrate and/or its equivalents and would, for example, include a product having 1.6 mg allithiamine instead of thiamine mononitrate.
  • The compositions, kits and methods of the present invention may comprise or use vitamin B2. Vitamin B2 is a component of two flavin coenzymes, flavin mononucleotide (FMN) and flavin adenine dinucleotide (FAD). These flavoenzymes are involved in a number of oxidation-reduction reactions including the conversion of pyridoxine and niacin. RDA, supra at 132. Flavoenzymes also play a role in a number of metabolic pathways such as amino acid deamination, purine degradation and fatty acid oxidation and thus help to maintain carbohydrate, amino acid and lipid metabolism.
  • In a specific embodiment, vitamin B2 may be in one or more of the forms of flavin mononucleotide (FMN), flavin adenine dinucleotide (FAD), riboflavin (also known as 7,8-dimethyl-10-((2R,3R,4S)-2,3,4,5-tetrahydroxypentyl)benzo[g]pteridine-2,4 (3H,10H)-dione or lactoflavin) and riboflavin derivatives such as riboflavin-5′-monophosphate, riboflavin-5′-monobutyrate and riboflavin-5′-monopalmitate. In a specific embodiment of the present invention, vitamin B2 may be included in the form of riboflavin.
  • In another specific embodiment, vitamin B2 may be included in amounts ranging from about 0.9 mg to about 2.7 mg. In another specific embodiment, vitamin B2 may be included in amounts ranging from about 1.5 mg to about 2.2 mg. In another specific embodiment, vitamin B2 may be included in amounts ranging from about 1.6 mg to about 2 mg. In another embodiment, vitamin B2 may be included in an amount of about 1.8 mg.
  • In another specific embodiment, vitamin B2 in the form of riboflavin may be included in amounts ranging from about 0.9 mg to about 2.7 mg. In another specific embodiment, vitamin B2 in the form of riboflavin may be included in amounts ranging from about 1.5 mg to about 2.2 mg. In another specific embodiment, vitamin B2 in the form of riboflavin may be included in amounts ranging from about 1.6 mg to about 2 mg. In another embodiment, vitamin B2 in the form of riboflavin may be included in an amount of about 1.8 mg.
  • In another specific embodiment, vitamin B2 may be included in specific ranges or amounts for each specific form. When provided in their specific forms, the provided numerical range or amount includes the amounts of the specific form and/or compounds that are equivalent to the specific form. For example, vitamin B2 may be in the form of riboflavin and may be included in the amount of about 1.8 mg. Accordingly, in this example, “riboflavin in the amount of about 1.8 mg” would include 1.8 mg of riboflavin and/or its equivalents and would, for example, include a product having 1.8 mg flavin mononucleotide instead of riboflavin.
  • The compositions, kits and methods of the present invention may comprise or use vitamin B3. Vitamin B3, or “niacin” is the common name for two compounds: nicotinic acid (also called niacin) and niacinamide (also called nicotinamide). Vitamin B3 is particularly important for maintaining healthy levels and types of fatty acids. It is also required for the synthesis of pyroxidine, riboflavin, and folic acid. RDA, supra at 137. Administration of vitamin B3 also may effect a reduction in total cholesterol (LDL) and very low density lipoprotein (VLDL) levels and an increase in high density lipoprotein (HDL) cholesterol levels. Nicotinamide adenine dinucleotide (NAD) and NAD phosphate (NADP) are active coenzymes of niacin. These coenzymes are involved in numerous enzymatic reactions such as glycolysis, fatty acid metabolism, and steroid synthesis. Henkin et al., 91 AM. J. MED. 239-46 (1991). In a specific embodiment, vitamin B3 may in the forms of niacin (nicotinic acid or pyridine-3-carboxylic acid), and nicotinamide (niacinamide) and salts and esters thereof. In a specific embodiment of the present invention, vitamin B3 may be included in the form of nicotinamide. In another specific embodiment, the present invention may include an equivalent molar amount of niacin.
  • In another specific embodiment, vitamin B3 may be included in amounts ranging from about 7.5 mg to about 22.5 mg. In another specific embodiment, vitamin B3 may be included in amounts ranging from about 12 mg to about 18 mg. In another specific embodiment, vitamin B3 may be included in amounts ranging from about 13.5 mg to about 16.5 mg. In another embodiment, vitamin B3 may be included in an amount of about 15 mg.
  • In another specific embodiment, vitamin B3 may be included in specific ranges or amounts for each specific form. When provided in their specific forms, the provided numerical range or amount includes the amounts of the specific form and/or compounds that are equivalent to the specific form. For example, vitamin B3 may be in the form of nicotinamide and may be included in the amount of about 15 mg. Accordingly, in this example, “nicotinamide in the amount of about 15 mg” would include 15 mg of nicotinamide and/or its equivalents and would, for example, include a product having 15 mg niacin instead of nicotinamide.
  • In another specific embodiment, vitamin B3 in the form of nicotinamide may be included in amounts ranging from about 7.5 mg to about 22.5 mg. In another specific embodiment, vitamin B3 in the form of nicotinamide may be included in amounts ranging from about 12 mg to about 18 mg. In another specific embodiment, vitamin B3 in the form of nicotinamide may be included in amounts ranging from about 13.5 mg to about 16.5 mg. In another embodiment, vitamin B3 in the form of nicotinamide may be included in an amount of about 15 mg.
  • The compositions, kits and methods of the present invention may comprise or use vitamin B6. The administration of vitamin B6 may reduce the levels of homocysteine. Bostom et al., 49 KIDNEY INT. 147-52 (1996). The active forms of vitamin B6, pyridoxal-5′-phosphate (PLP) and pyridoxamine-5′-phosphate, are coenzymes for numerous enzymes and as such, are important for gluconeogenesis, niacin formation, and erythrocyte metabolism. RDA, supra at 142-43. Vitamin B6 is a coenzyme for both cystathionine synthase and cystathionase, enzymes that catalyze the formation of cysteine from methionine. Homocysteine is an intermediate in this process and elevated levels of plasma homocysteine are recognized as a risk factor for both vascular disease (Robinson et al., 94 CIRCULATION 2743-48 (1996)) and neural tube defects (Locksmith & Duff, 91 OBSTET. GYNECOL. 1027-34 (1998)). In a specific embodiment of the present invention, vitamin B6 may be included in the forms of pyridoxine, 3-hydroxy-4,5-bis(hydroxymethyl)2-methylpyridine, 5′-deoxypyridoxal, 2-demethylpyridoxal(2-norpyridoxal), 2-propyl-2-norpyridoxal (2′-ethylpyridoxal), 6-methylpyridoxal, 2′-hydroxypyridoxal (2-hydroxymethyl-2-demethylpyridoxal or 2-hydroxymethyl-2-norpyridoxal), 4′-deoxypyridoxine 5′-phosphate, 5′-methylpyridoxal-5′-phosphate, pyridoxal N-oxide 5′-phosphate, Pyridoxal, Pyridoxamine, Pyridoxine-5′-phosphate (PNP), pyridoxal-5′-phosphate (PLP) and pyridoxamine-5′-phosphate (PMP), and their salts and chelates thereof. In a specific embodiment of the present invention, vitamin B6 may be included in the form of pyridoxine hydrochloride.
  • In another specific embodiment, vitamin B6 may be included in specific ranges or amounts for each specific form. When provided in their specific forms, the provided numerical range or amount includes the amounts of the specific form and/or compounds that are equivalent to the specific form. For example, vitamin B6 may be in the form of pyridoxine hydrochloride and may be included in the amount of about 2.5 mg. Accordingly, in this example, “pyridoxine hydrochloride in the amount of about 2.5 mg” would include 2.5 mg of pyridoxine hydrochloride and/or its equivalents and would, for example, include a product having 2.5 mg pyridoxamine instead of pyridoxine hydrochloride.
  • In another specific embodiment, vitamin B6 may be included in amounts ranging from about 1.2 mg to about 3.8 mg. In another specific embodiment, vitamin B6 may be included in amounts ranging from about 2.0 mg to about 3.0 mg. In another specific embodiment, vitamin B6 may be included in amounts ranging from about 2.25 mg to about 2.75 mg. In another embodiment, vitamin B6 may be included in an amount of about 2.5 mg.
  • The compositions, kits and methods of the present invention may comprise or use vitamin B9. Vitamin B9 is a generic name of a B-vitamin that includes multiple compounds with a general structure. For example, vitamin B9 encompasses the term folate, which itself is the generic name for many different forms of this water-soluble vitamin (vitamin B9), which is essential for DNA synthesis and, hence, cell division. Simpson et al., THE JOURNAL OF MATERNAL-FETAL AND NEONATAL MEDICINE, Micronutrients and women of reproductive potential: required dietary intake and consequences of dietary deficiency or excess. Part I—Folate, Vitamin B12, Vitamin B6, Epub 1-21, (2010). Indeed, folate encompasses numerous compounds that for example, are based on a pteridine ring, an aminobenzoic acid and one or more glutamic acid residues. Id. Folic acid (pteroglutamic acid or PGA) is a synthetic form of folate, and the first folate synthesised and used as a supplement. Id. The term folates may also be used in the generic sense to designate any members of the family of pteroylglutamates, or mixtures of them, having various levels of reduction of the pteridine ring, one-carbon substitutions and numbers of glutamate residues. PURE & APPL. CHEM., IUPAC-IUB Commission on Biochemical Nomenclature (CBN). Nomenclature and Symbols for Folic Acid and Related Compounds. Arch 59, No. 6: 833-836 (1987).
  • Vitamin B9, however, is not only defined by its structure, but also by its various functions. Indeed, vitamin B9 is essential for DNA synthesis and, hence, cell division and is required metabolically as a coenzyme in one-carbon transfer reactions. Simpson, supra. This vitamin has demonstrated the ability to prevent neural tube defects such as spina bifida caused by disturbed homocysteine metabolism. Vanderput et al., EXP. BIOL. MED. 243-70 (2001); DeFalco et al., 27 CLIN. EXP. OBSTET. GYNECOL. 188-90 (2000); Eskes, 27 CLIN. EXP. OBSTET. GYNECOL. 157-67 (2000); Locksmith & Duff, supra. Folic acid, a commonly used term synonymous with vitamin B9, is known to reduce the risk of multiple diseases. Clinical trials definitively demonstrated the effectiveness of folic acid supplementation in reducing the number of neural tube defects. Simpson et al., THE JOURNAL OF MATERNAL-FETAL AND NEONATAL MEDICINE, Micronutrients and women of reproductive potential: required dietary intake and consequences of dietary deficiency or excess. Part I—Folate, Vitamin B12, Vitamin B6, Epub 1-21, (2010). Indeed, folic acid supplementation in reducing the risk of neural tube defects and other congenital malformations is generally accepted. Pietrzik et al., CLIN PHARMACOKINET 49 (8): 535-548 (2010). Furthermore, evidence is accumulating to support a possible role of folic acid in the reduction in risk of other diseases, including dementia and certain types of cancer. Id. Lastly, folate or folate derivative thereof that increase blood folate levels, thereby reducing homocysteine levels, which is a common way to measure vitamin B9 effectiveness. Id.
  • Thus, in a specific embodiment of the present invention, vitamin B9 may include numerous forms. In a specific embodiment, vitamin B9 may be included in the form of folic acid. In another embodiment, vitamin B9 may be included one or more of the forms of folic acid, folacin, metafolin, folate and/or one or more natural isomers of folate including (6S)-tetrahydrofolic acid or a polyglutamyl derivative thereof, 5-methyl-(6S)-tetrahydrofolic acid or a polyglutamyl derivative thereof, 5-formyl-(6S)-tetrahydrofolic acid or a polyglutamyl derivative thereof, 10-formyl-(6R)-tetrahydrofolic acid or a polyglutamyl derivative thereof, 5,10-methylene-(6R)-tetrahydrofolic acid or a polyglutamyl derivative thereof, 5,10-methenyl-(6R)-tetrahydrofolic acid or a polyglutamyl derivative thereof and 5-formimino-(6S)-tetrahydrofolic acid or a polyglutamyl derivative thereof and the salts and esters thereof. In another embodiment, vitamin B9 may be in the form of a folate or folate derivative thereof that is eventually converted to 5-methyl-tetrahydrofolic acid in the body and/or is absorbed into the bloodstream as 5-methyl-tetrahydrofolic acid. Folates, such as folic acid and folate, are eventually absorbed in the body and converted to L-5-methyl-tetrahydrofolic acid 1n another embodiment, vitamin B9 may be in the form of a folate or folate derivative thereof that increases blood folate levels, thereby reducing homocysteine levels.
  • In another embodiment, vitamin B9 may be in the form of folate or reduced folates with various salts. In a specific embodiment, the folate and reduced folate are selected from the group consisting of D-glucosamine-folate, D-galactosamine-folate, D-glucosamine (6R,S)-tetrahydrofolate, D-glucosamine (6S)-tetrahydrofolate, D-glucosamine (6R)-tetrahydrofolate; D-galactosamine (6R,S)-tetrahydrofolate, D-galactosamine (6S)-tetrahydrofolate, D-galactosamine (6R)-tetrahydrofolate; D-glucosamine 5-methyl-(6R,S)-tetrahydrofolate, D-glucosamine 5-methyl-(6S)-tetrahydrofolate, D-glucosamine 5-methyl-(6R)-tetrahydrofolate; D-galactosamine 5-methyl-(6R,S)-tetrahydrofolate, D-galactosamine 5-methyl-(6S)-tetrahydrofolate, and D-galactosamine 5-methyl-(6R)-tetrahydrofolate.
  • In another specific embodiment, vitamin B9 may be included in amounts ranging from about 0.5 mg to about 1.5 mg. In another specific embodiment, vitamin B9 may be included in amounts ranging from about 0.8 mg to about 1.2 mg. In another specific embodiment, vitamin B9 may be included in amounts ranging from about 0.9 mg to about 1.1 mg. In another embodiment, vitamin B9 may be included in an amount of about 1.0 mg.
  • In another specific embodiment, vitamin B9 may be included in specific ranges or amounts for each specific form. When provided in their specific forms, the provided numerical range or amount includes the amounts of the specific form and/or compounds that are equivalent to the specific form. For example, vitamin B9 may be in the form folic acid and may be included in the amount of about 1.0 mg. Accordingly, in this example, “folic acid in the amount of about 1.0 mg” would include 1.0 mg of folic acid and/or its equivalents and would, for example, include a product having 1.0 mg 5-methyl-(6S)-tetrahydrofolic acid instead of folic acid.
  • In a specific embodiment, vitamin B9 may be in the form of folic acid. In another specific embodiment, vitamin B9 in the form of folic acid may be included in amounts ranging from about 0.5 mg to about 1.5 mg. In another specific embodiment, vitamin B9 in the form of folic acid may be included in amounts ranging from about 0.8 mg to about 1.2 mg. In another specific embodiment, vitamin B9 in the form of folic acid may be included in amounts ranging from about 0.9 mg to about 1.1 mg. In another embodiment, vitamin B9 in the form of folic acid may be included in an amount of about 1.0 mg.
  • The compositions, kits and methods of the present invention may comprise or use vitamin B12. Vitamin B12 can be converted to the active coenzymes, methylcobalamin and 5′-deoxyadenosylcobalamin. These coenzymes are necessary for folic acid metabolism, conversion of coenzyme A and myelin synthesis. Methylcobalamin also catalyzes the demethylation of a folate cofactor which is involved in DNA synthesis. A lack of demethylation may result in folic acid deficiency. RDA, supra at 159-160. Deoxyadenosylcobalamin is the coenzyme for the conversion of methylmalonyl-CoA to succinyl-CoA, which plays a role in the citric acid cycle. Cobalamin, along with pyridoxine and folic acid, also are implicated in the proper metabolism of homocysteine, a breakdown product of the amino acid methionine, which is correlated with an increased risk of heart disease due to its negative effects on endothelial function. In a specific embodiment of the present invention, vitamin B12 may be in one or more of the forms of cobalamin, methylcobalamin, 5′-deoxyadenosylcobalamin (adenosylcobalamin or cobamamide), cyanocobalamin, hydroxycobalamin and mecobalamin.
  • In another specific embodiment, vitamin B12 may be included in amounts ranging from about 6 μg to about 18 μg. In another specific embodiment, vitamin B12 may be included in amounts ranging from about 9.6 μg to about 14.4 μg. In another specific embodiment, vitamin B12 may be included in amounts ranging from about 10.8 μg to about 13.2 μg. In another embodiment, vitamin B12 may be included in an amount of about 12 μg.
  • In another specific embodiment, vitamin B12 may be included in specific ranges or amounts for each specific form. When provided in their specific forms, the provided numerical range or amount includes the amounts of the specific form and/or compounds that are equivalent to the specific form. For example, vitamin B12 may be in the form cyanocobalamin and may be included in the amount of about 12 μg. Accordingly, in this example, “cyanocobalamin in the amount of about 12 μg” would include 12 μg of cyanocobalamin and/or its equivalents and would, for example, include a product having 12 μg methylcobalamin instead of cyanocobalamin.
  • The compositions, kits and methods of the present invention may comprise or use vitamin C. The major biochemical role of water-soluble vitamin C is as a co-substrate in metal catalyzed hydroxylations. Like beta carotene, vitamin C has antioxidant properties. It interacts directly with superoxide hydroxyl radicals and singlet oxygen, and also provides antioxidant protection for folate and vitamin E, keeping vitamin E in its most potent form. Vitamin C may afford protective effects against preeclampsia by participating in the scavenging of free radicals. Indeed, significantly lower levels of vitamin C have been observed in preeclamptic women than in controls. Woods et al., 185(1) AM. J. OBSTET. GYNECOL. 5-10 (2001); Kharb, 1 EURO. J. OBSTET. GYNECOL. REPROD. BIOL. 37-39 (2000); Milczarek et al., 210 MOL. CELL. BIOCHEM. 65-73 (2000). Vitamin C also enhances the absorption of iron. RDA, supra at 115. In addition, vitamin C is required for collagen synthesis, epinephrine synthesis, and bile acid formation. Moreover, vitamin C has been implicated in inhibiting atherosclerosis by being present in extracellular fluid of the arterial wall and potentiating nitric oxide activity, thus normalizing vascular function. In a specific embodiment of the present invention, vitamin C may be included in the forms of ascorbic acid, ascorbates (calcium or sodium ascorbate), dehydroascorbic acid and salts, ascorbyl palmitate, ascorbyl phosphates and salts (such as sodium or magnesium ascorbyl phosphate), ascorbyl tetraisopalmitate, tetrahexyldecyl ascorbate, ascorbyl sulfates and salts, acylated ascorbic acid derivatives (such as 6-O-acyl-2-O-alpha-D-glucopyranosyl-L-ascorbic acids), 6-bromo-6-deoxy-L-ascorbic acid, and ascorbate salts. In a specific embodiment, vitamin C may be included in the form of ascorbic acid.
  • In another specific embodiment, vitamin C may be included in amounts ranging from about 15 mg to about 45 mg. In another specific embodiment, vitamin C may be included in amounts ranging from about 24 mg to about 36 mg. In another specific embodiment, vitamin C may be included in amounts ranging from about 27 mg to about 33 mg. In another embodiment, vitamin C may be included in an amount of about 30 mg.
  • In another specific embodiment, vitamin C may be included in specific ranges or amounts for each specific form. When provided in their specific forms, the provided numerical range or amount includes the amounts of the specific form and/or compounds that are equivalent to the specific form. For example, vitamin C may be in the form ascorbic acid and may be included in the amount of about 30 mg. Accordingly, in this example, “ascorbic acid in the amount of about 30 mg” would include 30 mg of ascorbic acid and/or its equivalents and would, for example, include a product having 30 mg ascorbyl palmitate instead of ascorbic acid.
  • In another specific embodiment, vitamin C in the form of ascorbic acid may be included in amounts ranging from about 15 mg to about 45 mg. In another specific embodiment, vitamin C in the form of ascorbic acid may be included in amounts ranging from about 24 mg to about 36 mg. In another specific embodiment, vitamin C in the form of ascorbic acid may be included in amounts ranging from about 27 mg to about 33 mg. In another embodiment, vitamin C in the form of ascorbic acid may be included in an amount of about 30 mg.
  • The compositions, kits and methods of the present invention may comprise or use vitamin D. In another embodiment, the compositions and methods of the present invention may include a beneficially increased supplementation of vitamin D. Vitamin D is a fat-soluble “hormone like” substance important for the maintenance of healthy bones. This vitamin increases the absorption of calcium and phosphorous from the gastrointestinal tract, and improves mineral resorption into bone tissue. The result of this physiological function is a correlation between adequate systemic levels in pregnancy and a long-lasting reduction in osteoporotic fractures throughout the lifespan of the newborn. M F Holick, “Vitamin D,” in MODERN NUTRITION IN HEALTH AND DISEASE, p. 313, M E Shils, J A Olsen and M. Shikeeds., Plea and Febiger, Philadelphia, Pa. (1994); M K Javaid et al., LANCET 367(9504):36-43 (2006).
  • Moreover, recent research suggests that vitamin D has more positive physiological effects than previous thought. Bischoff-Ferrari HA, 624 ADV EXP MED BIOL. 55-71 (2008); Holick M F, 357 N. ENG. J. MED. 266-81, (2007); Parikin et al., 89(3) J CLIN ENDOCRINOL METAB. 1196-99 (2004). For example, it has recently been determined that vitamin D also has a role in the enhancement of vascular function, defense against cancer, immuno-competence, blood pressure regulation and possessing the ability to enhance cellular insulin sensitivity in the human body. Due to the additional roles that vitamin D plays in the human body, it has recently been determined that higher daily vitamin D intake beyond current recommendations may be associated with better health outcomes. Bischoff-Ferrari HA, supra. Indeed, studies suggest increasing the serum level of 25-hydroxyvitamin D, a beneficial derivative of vitamin D, to a 30 ng/ml serum range. Id. A 30 ng/ml appears to be the most advantageous serum levels in recent studies reviewing patient bone mineral density (BMD), lower extremity function, dental health, risk of falls, admission to nursing home, fractures, cancer prevention and incident hypertension. Id.
  • Further, studies suggest that an intake of about 1000 IU of vitamin D3 (cholecalciferol) per day for all adults may bring at least 50% of the population up to the 30 ng/ml serum range for 25-hydroxyvitamin D. Id. Current nutritional supplements, however, do not provide a high enough dosage for obtaining such a high serum level of 25-hydroxyvitamin D. Presently, the suggested daily amount of vitamin D, as stated by the U.S. Dietary Reference Intake for adequate intake (AI) of vitamin D for infants, children and men and women aged 19-50 is 200 IU/day. Adequate intake increases to 400 IU/day for men and women aged 51-70 and up to 600 IU/day past the age of 70. Id. Due to these studies, present nutritional supplements may be insufficient to remedy the current U.S. and global epidemic related to vitamin D deficiency.
  • Indeed, research findings indicate vitamin D status during pregnancy is more important than previous thought. Vitamin D's role continues to expand in for example, infant immunity, neurodevelopment, birth weight, and incidence of asthma. Growing research findings regarding the importance of this hormone-like compound is due, in large part, to the fact that vitamin D receptors have now been identified on nearly every tissue and cell in the human body. H F DeLuca et al., FASEB J 15:2579-2585 (2001); D. Eyles et al., NEUROSCIENCE 118(3):641-653 (2003); C A Mannion et al., CMAJ 174(9):1273-1277 (2006); B W Hollis et al., CMAJ 174(9):1287-1290 (2006); American Academy of Allergy, Asthma and Immunology Annual Meeting, Miami, Fla. (March 2006). A nutritional supplement that includes a higher dosage amount of vitamin D, as compared to present nutritional supplements and, specifically, prenatal supplements, is therefore currently needed. Thus, one embodiment of the present invention includes compositions, kits and methods that provide a beneficial increased supplementation of vitamin D, specifically, for example prenatal, pregnant or breast feeding women.
  • The vitamin D of the compositions and methods of the present invention may comprise vitamin D. In a specific embodiment of the present invention, vitamin D may be in one or more the forms of vitamin D3 (also known as calciol or cholecalciferol or colecalciferol), vitamin D2 (also known as calciferol, ergocalciol, ergocalciferol, ercalciol, Deltalin or Viosterol), previtamin D2, ergosterol, calcitriol (also known as 1,25-dihydroxycholecalciferol), 7-dehydrocholesterol, vitamin D1, vitamin D4 (also known as 22-dihydroergocalciferol, 22,23-dihydroercalciol or (24S)-methylcalciol), vitamin D5 (also known as (24S)-Ethylcalciol or sitocalciferol), 7-dehydrositosterol, Lumisterol, 25-hydroxyvitamin D, all steroids that exhibit the biological activity of calciol, 25-fluorocalciol, (3S)-3-amino-3-deoxycalciol, 11α-acetoxycalciol, calcidiol (also known as 25-hydroxycholecalciferol or calcifediol), ercalcitriol, calcitetrol, tacalciol (also known as tachysterol3), (5E)-isocalciol (also known as isovitamin D3), Dihydroercalciol (also known as dihydrotachysterol3), (1S)-Hydroxycalciol (also known as 1α-hydroxycholecalciferol or alfacaleidol), (24R)-Hydroxycalcidiol (also known as 24(R),25-dihydroxycholecalciferol), Ercalcidiol, Ercalcitriol, Ertacalciol, (5E)-(10S)-10,19-Dihydroercalciol (also known as dihydrotachysterol2), (6Z)-Tacalciol (also known as precalciferol or pre-vitamin D), and (22E)-(24R)-Ethyl-22,23-didehydrocalciol also known as vitamin D6.
  • In one embodiment of the invention, vitamin D may be present in the amount ranging from about 400 IU to about 1600 IU. In another embodiment, vitamin D may be present in the amount ranging from about 750 IU to about 1250 IU. In another embodiment, vitamin D is present in the amount ranging form about 900 IU to about 1100 IU. In another embodiment, vitamin D is present in the amount of about 1000 IU.
  • In another specific embodiment, vitamin D may be included in specific ranges or amounts for each specific form. When provided in their specific forms, the provided numerical range or amount includes the amounts of the specific form and/or compounds that are equivalent to the specific form. For example, vitamin D may be in the form vitamin D3 and may be included in the amount of about 1000 IU. Accordingly, in this example, “vitamin D3 in the amount of about 30 mg” would include 1000 IU of vitamin D3 and/or its equivalents and would, for example, include a product having 1000 IU mg vitamin D2 instead of vitamin D3.
  • In another embodiment of the present invention, the vitamin D of the compositions, kits and methods of the present invention may be vitamin D3. In the body, vitamin D3 is produced when its precursor is exposed to ultraviolet irradiation (e.g., sunlight) and then hydroxylated in the liver to form 25-hydroxyvitamin D3, the major form of vitamin D in the circulation. This form of the vitamin may be hydroxylated again in the kidney, yielding 1,25 hydroxyvitamin D3, the most potent form of vitamin D. As noted above, vitamin D3 plays a role in the maintenance of calcium and phosphorus homeostasis, but it is also active in cell differentiation and immune function.
  • In one embodiment of the invention, vitamin D in the form of vitamin D3 may be present in the amount ranging from about 400 IU to about 1600 IU. In another embodiment, vitamin D in the form of vitamin D3 may be present in the amount ranging from about 750 IU to about 1250 IU. In another embodiment, vitamin D in the form of vitamin D3 may be present in the amount ranging form about 900 IU to about 1100 IU. In another embodiment, vitamin D in the form of vitamin D3 may be present in the amount of about 1000 IU.
  • In another embodiment, vitamin D may be present in an amount determined by a measure of mass, as opposed to International Units. One International Unit (IU) of vitamin D is defined as the biological equivalent of about 0.025 μg of vitamin D3. See REMINGTON, THE SCIENCE AND PRACTICE OF PHARMACY, page 1800 (20th ed 2000) (hereinafter, “Remington”). Accordingly, 400 IU to about 1600 IU is the biological equivalent of about 10 μg to about 40 μg. In another example, about 750 IU to about 1250 IU is the biological equivalent of about 18.75 μg to about 31.25 μg. In another example, about 900 IU to about 1100 IU is the biological equivalent of about 22.5 μg to about 27.5 μg. In another example, 1000 IU is the biological equivalent of about 25 μg.
  • The compositions, kits and methods of the present invention may comprise or use vitamin E. Vitamin E is a fat-soluble vitamin antioxidant found in biological membranes where it protects the phospholipid membrane from oxidative stress. Vitamin E inhibits the oxidation of unsaturated fatty acids by trapping peroxyl free radicals. It is also an antiatherogenic agent, and studies have demonstrated a reduced risk of coronary heart disease with increased intake of vitamin E. Stampfer et al., 328 NEW ENG. J. MED. 1444-49 (1993). In addition, vitamin E, like beta carotene and vitamin C, may afford protective effects against preeclampsia by participating in the scavenging of free radicals. As with vitamin C, significantly lower levels of vitamin E have been observed in preeclamptic women than in controls. Woods et al., AM J OBSTET GYNECOL, 185(1):5-10 (2001); Kharb, EURO. J. OBSTET GYNECOL REPROD BIOL, 1:37-39 (2000); Milczarek et al., MOL CELL BIOCHEM, 210:65-73 (2000). In a specific embodiment of the present invention, vitamin E may be included in one or more of the forms of alpha, beta, gamma, and delta tocopherols in its natural or synthetic (dl) forms; alpha, beta, gamma, and delta tocotrienols in its natural or synthetic (dl) forms, dl-alpha tocopheryl derivatives such as dl-alpha tocopheryl esters, dl-alpha-tocopheryl acetate or succinate and d-alpha-tocopheryl acetate or dl-alpha tocopheryl phosphates (such as Ester-E®). In a specific embodiment of the present invention, vitamin E may be included in the form of d-alpha-tocopheryl acetate. In another specific embodiment, vitamin E may be included in the form of an equivalent molar amount of d-alpha tocopheryl succinate.
  • In another specific embodiment, vitamin E may be included in amounts ranging from about 10 IU to about 30 IU. In another specific embodiment, vitamin E may be included in amounts ranging from about 15 IU to about 25 IU. In another specific embodiment, vitamin E may be included in amounts ranging from about 18 IU to about 22 IU. In another embodiment, vitamin E may be included in an amount of about 20 IU.
  • In another specific embodiment, vitamin E may be included in specific ranges or amounts for each specific form. When provided in their specific forms, the provided numerical range or amount includes the amounts of the specific form and/or compounds that are equivalent to the specific form. For example, vitamin E may be in the form d-alpha-tocopheryl acetate and may be included in the amount of about 20 IU. Accordingly, in this example, “d-alpha-tocopheryl in the amount of about 20 IU” would include 20 IU of d-alpha-tocopheryl and/or its equivalents and would, for example, include a product having 20 IU alpha-tocotrienol instead of d-alpha-tocopheryl.
  • The compositions, kits and methods of the present invention may comprise or use iron. A primary function of iron is to carry oxygen to bodily tissues via the hemoglobin part of red blood cells. Supplemental intake of iron is critical to preventing anemia, a disorder associated with a variety of physiological states including, for example, pregnancy. Bothwell, 72(Supp.) AM. J. CLIN. NUTR. 257S-64S (2000). Severe anemia may have adverse effects upon a mother and a fetus. Specifically, significant depression of hemoglobin has been associated with poor pregnancy outcome. Black, supra; Sifakis & Pharmakides, 900 ANN. N.Y. ACAD. SCI. 125-36 (2000). The, compositions, kits and methods of the present invention may include iron in one or more of the forms of elemental iron, in the form of a salt, chelated form, non-chelated form, chelated to an amino acid, carbonyl iron, ferrous gluconate, ferrous fumarate, polysaccharide iron complex, elemental polysaccharide iron, polysaccharide iron, ferrous (II)-bis-glycinate chelate, ferrous asparto glycinate, ferrous bisglycinate, ferrous bisglycinate hydrochloride, ferrous bisglycinate, elemental ferrous bisglycinate, ferrous sulfate, ferronyl (micronized), as Iron Aid, iron protein succinylate, carbonyl iron, Sumalate iron, Heme iron complex, as Ferrochel amino acid chelate, heme iron polypeptide as Proferrin-bovine source, as heme iron polypeptide (bovine source) as sodium iron EDTA (Ferrazone), ferric ammonium citrate, elemental iron, and ferric pyrophosphate.
  • In a specific embodiment of the present invention, iron may be included in the form of polysaccharide iron complex. In another specific embodiment, iron may be included in the form of an equivalent molar amount of ferrous fumurate. In another specific embodiment, iron may be included in amounts ranging from about 14.5 mg to about 43.5 mg. In another specific embodiment, iron may be included in amounts ranging from about 21.6 mg to about 32.4 mg. In another specific embodiment, iron may be included in amounts ranging from about 26 mg to about 32 mg. In another embodiment, iron may be included in an amount of about 29 mg.
  • In another specific embodiment, iron may be included in specific ranges or amounts for each specific form. When provided in their specific forms, the provided numerical range or amount includes the amounts of the specific form and/or compounds that are equivalent to the specific form. For example, iron may be in the form polysaccharide iron complex and may be included in the amount of about 29 mg. Accordingly, in this example, “polysaccharide iron complex in the amount of about 29 mg” would include 29 mg of polysaccharide iron complex and/or its equivalents and would, for example, include a product having 29 mg ferrous fumarate instead of polysaccharide iron complex.
  • The compositions, kits and methods of the present invention may comprise or use iodine. Iodine provides nutritional benefits as it is an essential component of the thyroid hormones that are involved in the regulation of various enzymes and metabolic processes, such as thyroxine and triiodothyronine. Thyroid hormones play pivotal roles in metabolism. Consequences of deficiency (hypothyroidism) and excess (hyperthyroidism) are well-recognised clinically. Simpson et al., THE JOURNAL OF MATERNAL-FETAL AND NEONATAL MEDICINE, Micronutrients and women of reproductive potential: required dietary intake and consequences of dietary deficiency or excess. Part II—Vitamin D, Vitamin A, Iron, Zinc, Iodine, Essential Fatty Acids, 1-2, epub online 2010. Indeed, iodine deficiency disorders (IDD) include mental retardation, hypothyroidism, goiter, cretinism, and varying degrees of other growth and developmental abnormalities which can be a result from inadequate thyroid hormone production from lack of sufficient iodine. Further, iodine is an important element in breast milk for infant nutrition. An adequate concentration of iodine in breast milk is essential to provide for optimal neonatal thyroid hormone stores and to prevent impaired neurological development in breast-fed neonates. In many countries of the world, low iodine content of the breast milk indicates less than optimum maternal and infant iodine nutrition. F. Azizi et al., CLIN ENDOCRINOL; 70(5):803-9 (2009). Iodine deficiency, is a major public health problem in nearly all countries, particularly for women during pregnancy and lactation. The National Health and Nutrition Examination survey data also found 14.9% of women aged 15-44 years and 6.9% of pregnant women to have urinary iodine concentrations of only 50 mg/L, indicating iodine intake of less than 100 mg daily. Simpson, supra. The American Thyroid Association thus also recommends that women receive 150 mg iodine supplements daily during pregnancy and during lactation, which is often the upper limit for iodine dosing amounts in prenatal supplements. Id. Regardless of such recommendations, iodine nutrition and supplementation is lacking. For example, in Europe, most women are iodine deficient during pregnancy, with less than 50% receiving iodine supplementation; of 40 countries, only nine met the requirements of iodised salt at the household level to be at least 90% of the DRI. Id. Iodine nutrition of women of childbearing age thus remains inadequate and an area worthy of public health concern. Id. A nutritional supplement that includes a higher dosage amount of iodine, as compared to present nutritional supplements and, specifically, prenatal supplements, is therefore currently needed. Thus, one embodiment of the present invention includes compositions, kits and methods that provide a beneficial increased supplementation of iodine, specifically, for example prenatal, pregnant or breast feeding women.
  • In a specific embodiment, iodine may be in the forms of elemental iodine, iodized salt, Lugol's iodine, sodium iodide, potassium iodide, potassium iodate, nascent iodine, and Nano-Colloidal Detoxified Iodine. In another specific embodiment, iodine may be present in the amounts ranging from about 75 μg to about 225 μg. In another embodiment, iodine may be present in the amounts ranging from about 120 μg to about 180 μg. In another embodiment, iodine may be present in the amounts ranging from about 135 μg to about 165 μg. In another embodiment, iodine may be present in the amount of about 150 μg.
  • In another specific embodiment, iodine may be included in specific ranges or amounts for each specific form. When provided in their specific forms, the provided numerical range or amount includes the amounts of the specific form and/or compounds that are equivalent to the specific form. For example, iodine may be in the form potassium iodide and may be included in the amount of about 150 μg. Accordingly, in this example, “potassium iodide in the amount of about 150 μg” would include 150 μg of potassium iodide and/or its equivalents and would, for example, include a product having 150 μg Nano-Colloidal Detoxified Iodine instead of potassium iodide.
  • The compositions, kits and methods of the present invention may comprise or use magnesium. Magnesium is found primarily in both bone and muscle and is important for over 300 different enzyme reactions. A primary function of magnesium is to bind to phosphate groups in adenosine triphosphate (ATP), thereby forming a complex that assists in the transfer of ATP phosphate. Magnesium also functions within cells as a membrane stabilizer. Magnesium plays roles in nucleic acid synthesis, glycolysis, transcription of DNA and RNA, amino acid activation, membrane transport, transketolase reactions, and protein synthesis. James L. L. Groff et al., ADVANCED NUTRITION AND HUMAN METABOLISM 341 (2d ed. 1996). It is also involved in the formation of cAMP, a cytosolic second messenger that plays a role in cell signaling mechanisms. Magnesium also functions both synergistically and antagonistically with calcium in neuromuscular transmission. RDA, supra at 188. Specifically, magnesium is critical for the maintenance of electrochemical potentials of nerve and muscle membranes and the neuromuscular junction transmissions, particularly important in the heart. Not surprisingly, magnesium deficiency is tied to cardiovascular disease and hypertension. Agus et al., 17 CRIT. CARE CLIN. 175-87 (2001). Indeed, oral magnesium therapy improves endothelial function in patients with coronary disease. Shechter et al., 102 CIRCULATION 2353-58 (2000).
  • Magnesium is available in a variety of salts and can be included in the compositions, kits and methods of the present invention in either chelated or nonchelated form. In one specific embodiment of the present invention, magnesium may be included in the forms of elemental magnesium, in the form of a salt, in a chelated form, in a non-chelated form, magnesium acetate, magnesium carbonate, magnesium gluconate, magnesium chloride, magnesium citrate, magnesium silicate, magnesium stearate, magnesium sulfate, magnesium oxide, and magnesium chelated to an amino acid (magnesium glycinate, magnesium aspartate).
  • In another specific embodiment, magnesium may be present in the amounts ranging from about 10 mg to about 30 mg. In another embodiment, magnesium may be present in the amounts ranging from about 16 mg to about 24 mg. In another embodiment, magnesium may be present in the amounts ranging from about 18 mg to about 22 mg. In another embodiment, magnesium may be present in the amount of about 20 mg.
  • In another specific embodiment, magnesium may be included in specific ranges or amounts for each specific form. When provided in their specific forms, the provided numerical range or amount includes the amounts of the specific form and/or compounds that are equivalent to the specific form. For example, magnesium may be in the form magnesium oxide and may be included in the amount of about 20 mg. Accordingly, in this example, “magnesium oxide in the amount of about 20 mg” would include 20 mg of magnesium oxide and/or its equivalents and would, for example, include a product having 20 mg magnesium stearate instead of magnesium oxide.
  • The compositions, kits and methods of the present invention may comprise or use zinc. Zinc plays a role in numerous metabolic activities such as nucleic acid production, protein synthesis, and development of the immune system. There are more than 200 zinc metalloenzymes including aldolase, alcohol dehydrogenase, RNA polymerase, and protein kinase C. Zima et al., 17 BLOOD PURIF. 182-86 (1999). Zinc stabilizes RNA and DNA structures, forms zinc fingers in nuclear receptors, and is a component of chromatin proteins involved in transcription and replication. Deficiencies of zinc during pregnancy have been shown to contribute to severe fetal abnormalities. Srinivas et al., 68(6) INDIAN J. PEDIATR. 519-22 (2001); Yang et al., 13(4) BIOMED. ENVIRON. SCI. 280-86 (2000); King, 71(Supp.) AM. J. CLIN. NUTR. 1334S-43S (2000). Indeed, the recommended daily allowance for zinc increases during pregnancy. A higher dose of zinc, however, is associated with causing nausea in some patients. Thus, for pregnant women or other patients that are more susceptible to nausea, a conservative amount of zinc that still provides adequate nutritional supplementation is desirable. Zinc is available in many forms and may be included in the kits and methods of the present invention in chelated or nonchelated form.
  • In a specific embodiment of the present invention, zinc may be provided in one or more of the forms of elemental zinc, in the form of a salt, in a chelated form, in a non-chelated form, zinc acetate, zinc gluconate, zinc picolinate, zinc sulfate and zinc oxide. In a specific embodiment of the present invention, zinc may be included in the form of zinc oxide. In another specific embodiment, zinc may be included in amounts ranging from about 12.5 mg to about 37.5 mg. In another specific embodiment, zinc may be included in amounts ranging from about 20 mg to about 30 mg. In another specific embodiment, zinc may be included in amounts ranging from about 22.5 mg to about 27.5 mg. In another embodiment, zinc may be included in an amount of about 25 mg.
  • In another specific embodiment, zinc may be included in specific ranges or amounts for each specific form. When provided in their specific forms, the provided numerical range or amount includes the amounts of the specific form and/or compounds that are equivalent to the specific form. For example, zinc may be in the form zinc oxide and may be included in the amount of about 25 mg. Accordingly, in this example, “zinc oxide in the amount of about 25 mg” would include 25 mg of zinc oxide and/or its equivalents and would, for example, include a product having 25 mg zinc sulfate instead of zinc oxide.
  • The compositions, kits and methods of the present invention may comprise or use copper. Copper is an important component of the process of gene expression. Additionally, one of copper's most vital roles is to help form hemoglobin, which, as previously discussed, carries oxygen to tissues via its iron component. In this respect copper plays a key role in protecting against anemia. Further, deficiencies of copper may lead to neutropenia and bone abnormalities in pregnant and lactating women. Uauy et al., AMER J CLIN NUTR 67:952 S-959S (Supp.) (1998). In addition, a fetus must accumulate copper at a rate of 50 mcg×kg−1×d−1 over the latter half of pregnancy; any deficiency in accumulation may lead to low birth weight and protein-energy malnutrition. Id. Many forms of copper are known to those skilled in the art, including copper oxide (Reade Advanced Materials, Providence, R.I.). In a specific embodiment, copper may be included in the forms of a salt, in a chelated form, in a non-chelated form, cupric oxide, copper sulfate, copper gluconate, copper citrate, cupric acetate, alkaline copper carbonate, and copper salicylate.
  • In another specific embodiment, copper may be included in amounts ranging from about 1.0 mg to about 3.0 mg. In another specific embodiment, copper may be included in amounts ranging from about 1.6 mg to about 2.4 mg. In another specific embodiment, copper may be included in amounts ranging from about 1.8 mg to about 2.2 mg. In another embodiment, copper may be included in an amount of about 2.0 mg.
  • In another specific embodiment, copper may be included in specific ranges or amounts for each specific form. When provided in their specific forms, the provided numerical range or amount includes the amounts of the specific form and/or compounds that are equivalent to the specific form. For example, copper may be in the form copper oxide and may be included in the amount of about 2.0 mg. Accordingly, in this example, “copper oxide in the amount of about 2.0 mg” would include 2.0 mg of copper oxide and/or its equivalents and would, for example, include a product having 2.0 mg copper sulfate instead of copper oxide.
  • The compositions, kits and methods of the present invention may comprise or use omega-3 fatty acids. Omega-3 fatty acids play integral roles in physiological mechanisms that serve to prevent, treat and/or alleviate the occurrence or negative effects of some diseases and has shown multiple health-promoting properties in adults. For example, omega-3 fatty acids are linked to health benefits such as preventing the occurrence of cancer, preventing the occurrence of heart disease, and are helpful in brain health and immune function. Indeed, omega-3 fatty acids include essential fatty acids linked to numerous health benefits, such as docahexaenoic acid (or docosahexaenoic acid, DHA), eicosapentaenoic acid (EPA) and a-linolenic acid (ALA). In another specific embodiment, the compositions, kits and methods of the present invention may comprise or use Docahexaenoic acid (or docosahexaenoic acid, DHA). In another specific embodiment, the compositions, kits and methods of the present invention may comprise or use eicosapentaenoic acid (EPA). In another specific embodiment, the compositions, kits and methods of the present invention may comprise or use a-linolenic acid (ALA).
  • The omega-3 fatty acid DHA, a major component of fish oil, has been shown to be of particular importance, especially during pregnancy or for lowering blood pressure. Indeed, studies suggest that DHA, but not EPA, reduce ambulatory blood pressure and heart rate in hyperlipidemic men. T A Mori et al., HYPERTENSION. 34:253-260 (1999). The results of this study thus suggest that DHA is the principal fatty acid in fish and fish oils that is responsible for blood pressure and heart rate effects in humans. Id.
  • Further, DHA is vital for optimal fetal and infant brain/cognitive development, as well as for normal brain function throughout life. F M Rioux, O. Hernell et al., ACTA PAEDIATR 95(2):137-144 (2006). The sleep patterns of infants born to mothers with higher plasma phospholipid DHA suggest greater central nerve system maturity. S R Cheruku, C J Lammi-Keefe et al., AM J CLIN NUTR 76:608-613, 2002. Additionally, children with Attention Deficit Hyperactivity Disorder (ADHD) have been shown to have abnormal levels of DHA. E A Mitchell, M. Manku et al., CLIN PEDIATR 26:406-411 (1986); L J Stevens, J R Burgess et al., PHYSIOL BEHAV 59:915-920 (1996). Studies have indicated a correlation between maternal DHA intake and intelligence quotient in the child. The direct correlation between brain development and systemic DHA status is secondary to the fact that DHA is taken up by the brain in preference to other fatty acids. Adequate DHA levels in pregnancy have also been correlated with optimizing the length of gestation and decreasing the risk of neurodevelopmental psychopathology. These critical findings have prompted the National Institute of Health (NIH) to recommend that pregnant women consume at least 300 mg of omega-3 fatty acids during pregnancy. N. Neurenger et al., NUTR REV 44:285-294 (1986); G. Hornstra et al., AM J CLIN NUTR 71:285 S-291S (2000); I B Helland et al., PEDIATRICS 111:E39-E44 (2003); F. Facchinetti et al., EUR REV MED PHARMACOL SCI 9(1):41-48 (2005); R K McNamara et al., PROSTAGLANDINS LEUKOT ESSENT FATTY ACIDS (29 Aug. 2006).
  • DHA is also important for the development of the infant retina and improving the visual acuity of the infant. C A Francois, W E Connor et al., AM J CLIN NUTR 77:226-233 (2003). Preterm infants have a more rapid development of visual acuity if fed human milk or formula enriched with DHA, compared to standard formula. M H Jorgensen, K F Michaelsen et al., LIPIDS 31(1):99-105 (1996). An increase in visual acuity has also been observed to develop more rapidly in term infants breast-fed from mothers whose diets are supplemented with DHA. Id.
  • In addition to the aforementioned benefit of DHA to the developing child, this essential fatty acid has also shown multiple health-promoting properties in adults. These include anti-thrombotic, anti-inflammatory and anti-atherosclerotic activity, all of which reduce the risk of heart disease. M Laidlaw and B J Holub, AM J CLIN NUTR 77:37-42 (2003). Inverse relationships have also been found between systemic levels of omega-3 fatty acids such as DHA and incidence and severity of mood disorders and depression, including postpartum depression. Therefore, introduction of omega-3 during pregnancy has a double benefit, to both child and mother. F B Hu et al., JAMA 287(14):1815-1821 (2002); C. Von Schacky et al., ANN INTERN MED 130:554-562 (1999); G. Parker et al., AM J PSYCHIATRY 163(6):969-978 (2006); S J Otto et al., PROSTAGLANDINS LEUKOT ESSENT FATTY ACIDS 69(3):237-243 (2003).
  • For women, DHA is particularly useful in counteracting the progression of breast cancer. Human breast cancer cells exposed to DHA exhibit an increase in cell death by apoptosis. B A Stoll, BR J NUTR 87(3):193-198, 2002. DHA also inhibits cyclooxygenase-2, which promotes mammary carcinogenesis. Id. DHA supplementation during pregnancy has also been shown to increase the length of gestation by about six days, helping mothers carry to a healthy full term. C M Smuts et al., OBSTETRICS AND GYNECOLOGY 101(3):469-479 (2003).
  • Intake of omega-3 fatty acids such as DHA not only leads to their incorporation into cell membrane lipids (B A Stoll, BR J NUTR 87(3):193-198 (2002)), but also storage in adipose tissue and secretion in breast milk. C A Francois, W E Connor et al., AM J CLIN NUTR 77:226-233 (2003). Although the human body can derive a limited amount of DHA from another fatty acid known as alpha-linolenic acid, this process is inefficient for optimal needs. A rich dietary source of direct DHA is fish. Id. However, some lactating women are vegetarians, have limited access to fish or simply do not like fish. A further problem with encouraging increased fish intake in pregnancy is that most species contain methyl mercury (MeHg) in various amounts. MeHg is a potent neurotoxin that can increase the risk of retarded cognitive development. This concern prompted both the United States Environmental Protection Agency (2004) and the Food and Drug Administration (2001) to issue advisories recommending that pregnant women modify their fish consumption. These recommendations have resulted in a reduced intake of fish during pregnancy, thus helping to protect against fetal MeHg related harm. However, this has concurrently reduced maternal intake of DHA. In fact, a recent dietary study of over 100 pregnant or nursing women in the United States showed an astonishingly low intake of DHA on average (60-80 mg/day), and a dangerously low percentage (<2) consumed the aforementioned recommended intake of 300 mg/day of DHA as set forth by the NIH. JT Cohen et al., AM J PREV MED, 29:353-365 (2005); U.S. Department of Health and Human Services, U.S. Environmental Protection Agency, “What you need to know about mercury in fish and shellfish,” Report EPA-823-F-04-009 (March 2004); E. Oken et al., OBSTET GYNECOL 102:346-351 (2003).
  • DHA may be obtained in solid form, such as in a whole-cell microbial product, or in liquid form, such as in an oil. An example of DHA in oil form is DHASCO®-T vegetable oil from micro-algae (Martek Biosciences Corporation, Columbia, Md.). In a specific composition, the DHA is DHAgold®, life'sDHA™ (DHASCO®), any Algae Oil, Krill Oil and/or vegetarian DHA.
  • In a specific embodiment of the present invention, the source of DHA may be from one or more of animal, fish, plants, algae or microorganism production.
  • In another embodiment, the compositions, kits and methods of the present invention may include DHA derived from algae. DHA derived from algae, as opposed to being derived from fish oil, has numerous beneficial effects. First, the DHA from algae does not have the “fishy” smell that can come with DHA from fish oil. Indeed, high doses of DHA from fish oil may result in the patient having an unappealing after taste or a slight “fishy” body odor or “fishy” odor on the patient's breath. Second, DHA derived from algae can be more easily regulated to assure consistency and further remove the risk of added chemicals or other dangers. For example, DHA from algae would not have the risk of being tainted with mercury as opposed to DHA from fish oil. Thus, DHA from algae provides pregnant women and neonate with DHA without this risk and dangers of mercury. In a specific embodiment, the source of DHA may be from algae oil. In another specific embodiment, the source of algae oil may be one or more of microalgae Schizochytrium sp, microalgae Crypthecodinium cohnii, microalgae Ulkenia sp. SAM2179, microalgae Schizochytrium linacinum strain SC-1. In another specific embodiment the source of DHA may be Martek Oil C53-O100.
  • In another specific embodiment, omega-3 fatty acids may be included in amounts ranging from about 100 mg to about 300 mg. In another specific embodiment, omega-3 fatty acids may be included in amounts ranging from about 160 mg to about 240 mg. In another specific embodiment, omega-3 fatty acids may be included in amounts ranging from about 180 mg to about 220 mg. In another embodiment, omega-3 fatty acids may be included in an amount of about 200 mg.
  • In another specific embodiment, omega-3 fatty acids may be included in specific ranges or amounts for each specific form. When provided in their specific forms, the provided numerical range or amount includes the amounts of the specific form and/or compounds that are equivalent to the specific form. For example, omega-3 fatty acids may be in the form of DHA and may be included in the amount of about 200 mg. Accordingly, in this example, “DHA in the amount of about 200 mg” would include 200 mg of DHA and/or its equivalents and would, for example, include a product having 200 mg EPA instead of DHA.
  • In another specific embodiment, omega-3 fatty acids may be in the form of DHA and may be included in amounts ranging from about 100 mg to about 300 mg. In another specific embodiment, omega-3 fatty acids in the form of DHA may be included in amounts ranging from about 160 mg to about 240 mg. In another specific embodiment, omega-3 fatty acids in the form of DHA may be included in amounts ranging from about 180 mg to about 220 mg. In another embodiment, omega-3 fatty acids in the form of DHA may be included in an amount of about 200 mg.
  • The compositions, kits and methods of the present invention may include or use a combination of the included vitamins, nutrients and minerals just described. In a specific embodiment, the compositions, kits and methods of the present invention may include vitamin D, iodine, vitamin B1, vitamin B6, vitamin B12, vitamin B2, vitamin B9, vitamin B3, vitamin E, vitamin A, vitamin C, iron, zinc, copper, magnesium, omega 3 fatty acids and one or more pharmaceutically acceptable carriers.
  • In another embodiment, the vitamins, nutrients and minerals may be included or used in any specific form just described. In a specific embodiment, the omega 3 fatty acids may be DHA.
  • In another embodiment, the compositions, kits and methods of the present invention may include or use a combination of the included vitamins, nutrients and minerals in the ranges or amounts just described.
  • In a specific embodiment, the compositions, kits and methods of the present invention may include or use vitamin D in an amount of about 500 I.U. to about 1500 I.U., iodine in an amount of about 75 μg to about 225 μg, vitamin B1 in an amount of about 0.8 mg to about 2.4 mg, vitamin B6 in an amount of about 1.2 mg to about 3.8 mg, vitamin B12 in an amount of about 6 μg to about 18 μg, vitamin B2 in an amount of about 0.9 mg to about 2.7 mg, vitamin B9 in an amount of about 0.5 mg to about 1.5 mg, vitamin E in an amount of about 10 I.U. to about 30 I.U., vitamin A in an amount of about 550 I.U. to about 1650 I.U., vitamin C in an amount of about 15 mg to about 45 mg, vitamin B3 in an amount of about 7.5 mg to about 22.5 mg, iron in an amount of about 14.5 mg to about 43.5 mg, zinc in an amount of about 12.5 mg to about 37.5 mg, copper in an amount of about 1.0 mg to about 3.0 mg, magnesium in an amount of about 10 mg to about 30 mg, and omega 3 fatty acids comprising DHA in an amount of about 100 mg to about 300 mg. In a specific embodiment, the composition s, kits and methods of the present invention may include or use vitamin D in an amount of about 1000 I.U., iodine in an amount of about 150 μg, vitamin B1 in an amount of about 1.6 mg, vitamin B6 in an amount of about 2.5 mg, vitamin B12 in an amount of about 12 μg, vitamin B2 in an amount of about 1.8 mg, vitamin B9 in an amount of about 1.0 mg, vitamin E in an amount of about 20 I.U., vitamin A in an amount of about 1100 I.U., vitamin C in an amount of about 30 mg, vitamin B3 in an amount of about 15 mg, iron in an amount of about 29 mg, zinc in an amount of about 25 mg, copper in an amount of about 2.0 mg, magnesium in an amount of about 20 mg, and omega 3 fatty acids comprising DHA in an amount of about 200 mg.
  • In one embodiment of the present invention, vitamin D3, iodine, vitamin B1, vitamin B6, vitamin B12, vitamin B2, vitamin B9, vitamin B3, vitamin E, vitamin A, vitamin C, iron, zinc, copper, magnesium, and omega 3 fatty acids may be provided in one composition. In a specific embodiment, the composition may be in the dosage form of a gelcap. To ensure that all such ingredients may be provided in one gelcap composition, various inactive ingredients and pharmaceutically acceptable carries may be added. In a specific embodiment, a wetting, stabilizing agent may be used for the gelcap composition, In a specific embodiment, the wetting or stabilizing agent is lecithin oil. In another specific embodiment beeswax may be added. In another specific embodiment, soybean oil may be added.
  • In another embodiment, the present invention may comprise one or more compositions in a kit. In a specific embodiment, the one or more compositions may include or use a combination of the vitamins, nutrients and minerals just described. In a specific embodiment, the one or more compositions may collectively use or include vitamin D, iodine, vitamin B1, vitamin B6, vitamin B12, vitamin B2, vitamin B9, vitamin B3, vitamin E, vitamin A, vitamin C, iron, zinc, copper, magnesium, omega 3 fatty acids and one or more pharmaceutically acceptable carriers.
  • In a specific embodiment, the two compositions may collectively use or include vitamin D, iodine, vitamin B1, vitamin B6, vitamin B12, vitamin B2, vitamin B9, vitamin B3, vitamin E, vitamin A, vitamin C, iron, zinc, copper, magnesium, omega 3 fatty acids and one or more pharmaceutically acceptable carriers.
  • In a specific embodiment, the multiple compositions, kits and methods of the present invention may collectively include or use vitamin D in an amount of about 500 I.U. to about 1500 I.U., iodine in an amount of about 75 μg to about 225 μg, vitamin B1 in an amount of about 0.8 mg to about 2.4 mg, vitamin B6 in an amount of about 1.2 mg to about 3.8 mg, vitamin B12 in an amount of about 6 μg to about 18 μg, vitamin B2 in an amount of about 0.9 mg to about 2.7 mg, vitamin B9 in an amount of about 0.5 mg to about 1.5 mg, vitamin E in an amount of about 10 I.U. to about 30 I.U., vitamin A in an amount of about 550 I.U. to about 1650 I.U., vitamin C in an amount of about 15 mg to about 45 mg, vitamin B3 in an amount of about 7.5 mg to about 22.5 mg, iron in an amount of about 14.5 mg to about 43.5 mg, zinc in an amount of about 12.5 mg to about 37.5 mg, copper in an amount of about 1.0 mg to about 3.0 mg, magnesium in an amount of about 10 mg to about 30 mg, and omega 3 fatty acids comprising DHA in an amount of about 100 mg to about 300 mg.
  • In a specific embodiment, the multiple compositions, kits and methods of the present invention may collectively include or use vitamin D in an amount of about 1000 I.U., iodine in an amount of about 150 μg, vitamin B1 in an amount of about 1.6 mg, vitamin B6 in an amount of about 2.5 mg, vitamin B12 in an amount of about 12 μg, vitamin B2 in an amount of about 1.8 mg, vitamin B9 in an amount of about 1.0 mg, vitamin E in an amount of about 20 I.U., vitamin A in an amount of about 1100 I.U., vitamin C in an amount of about 30 mg, vitamin B3 in an amount of about 15 mg, iron in an amount of about 29 mg, zinc in an amount of about 25 mg, copper in an amount of about 2.0 mg, magnesium in an amount of about 20 mg, and omega 3 fatty acids comprising DHA in an amount of about 200 mg
  • In a specific embodiment, active ingredients such as the vitamins, minerals and nutrients of the present invention, may be included in overages. Adding overages of these compounds may be necessary to meet the amounts claimed on the product label and product insert to ensure that those recited amounts are met throughout the shelf life of the product. Indeed, because of US regulatory requirements that label values reflect minimum contents of these nutrients, deviations in actual nutrient content from label values are usually thought to tend toward overages. Dwyer et al., ANAL BIOANAL CHEM, 389:37-46 (2007). In a specific embodiment, one or more of the vitamins, minerals and nutrients may be included in the compositions and methods of the present invention in overages of the recited, specific label amounts of about 100% to about 150% of the label amount, although the overages are dependant on the stability of each ingredient. For example, overages of vitamin D and vitamin B12 may be necessary due to the lack of stability of specific forms. In another example, 5-methyltetrahydrofolate, a form of vitamin B9, is degraded by light, temperature and may degrade during processing and storage. Overages may be larger for some vitamins particularly those that are less stable and more likely to deteriorate with a long shelf life, those that have other functions (such as antioxidants) in the product itself; for minerals, excess amounts with large overages are probably less likely because of their increased bulk and shelf life stability. Dwyer et al., ANAL BIOANAL CHEM. 389:37-46 (2007). Accordingly, when overages are included for any specific active ingredient, at some point in time, these ingredients with overages will degrade so that they fall within the amounts provided in the specific label. Thus, there is no literal difference between the amounts for active ingredients that include overages, and those amounts listed on the specific label. Furthermore, overages provide an equivalent efficacy of the active ingredient over the shelf life of the product. Accordingly, an active ingredient provided in overage amounts is an insubstantial change and performs substantially the same function, in substantially the same way, and leads to substantially the same result as that same active ingredient in the amounts as provided on the specific label.
  • In another embodiment, the nutritional supplements may include multiple vitamins, nutrients and minerals in one composition. Providing a single composition multivitamin and multinutrient supplement is an appealing feature because it improves patient compliance. Patients, and specifically for example, pregnant patients, often have nausea, and may have difficulties taking multiple pills. A one pill or one composition nutritional supplement that includes the beneficial vitamins, nutrients and minerals in appropriate dosage amounts would thus be beneficial for improving patient compliance in for example, pregnant women. In a specific embodiment one or more of the compositions may be in the dosage form of a gelcap.
  • In another specific embodiment, the compositions, kits and methods of the present invention may be in the form of a liquid gelcap which may consist of a filler comprising one or more pharmaceutically active materials dissolved or dispersed in an appropriate liquid vehicle encapsulated in a gelatin shell generally comprising gelatin together with a plasticizer such as glycerin or sorbitol. The filler material may comprise, for example, polyethylene glycols. See, for example, U.S. Pat. Nos. 4,780,316; 5,419,916; 5,641,512; and 6,589,536 which are expressly incorporated by reference herein.
  • A liquid gelcap has numerous advantages. First, it retains many of the advantages of consumer acceptance and is easier to swallow due to the outer coating being a soft and elastic gelatin shell. Also, liquid compositions are well suited for encapsulation within a soft gelatin shell, creating flexibility that further assists in the capsule being easier to swallow. The active drug contained in the liquid form also has advantages in dispersing the drug to the active site. For example, the active drug does not first have to dissolve in the gastrointestinal tract, thereby facilitating absorption of the pharmacologically active substance. See, for example, U.S. Pat. No. 6,689,382 which is expressly incorporated by reference herein. Other formulations take advantage of the liquid form by creating a sustained release gelatin capsule, thereby permitting the delivery of the drug in a controlled fashion. See, for example, U.S. Pat. Nos. 5,324,280 and 6,929,803, which are expressly incorporated by reference herein. Many shell and fill formulations are discussed in “Advances in Softgel Formulation Technology”, M. S. Patel, F. S. S. Morton and H. Seager, Manufacturing Chemists, July 1989; “Soft Elastic Gelatin Capsules: A Unique Dosage Form”, William R. Ebert, Pharmaceutical Technology, October 1977; and “Soft gelatin capsules: a solution to many tableting problems”, H. Seager, Pharmaceutical Technology, September 1985.
  • In a specific embodiment, the present invention may comprise kits or compositions in the dosage form of a soft-gel gelcap. A soft-gel is a one-piece, sealed, soft gelatin shell that contains a solution, a suspension, or a semi-solid paste. Soft-gels are predominantly used to contain liquids wherein the active ingredients are present in the dissolved or suspended state. Soft-gels have been widely known and used for many years and for a variety of purposes. Because soft-gels have properties that are quite different from two-piece, hard shell capsules, the soft-gels are capable of retaining a liquid fill material. Soft-gels are often used to encapsulate consumable materials, including vitamins, dietary supplements, pharmaceuticals, and the like, in a liquid vehicle or carrier. Soft-gels are a unique dosage form that can provide distinct advantages over more traditional dosage forms such as tablets, hard-shell capsules, and liquids. These advantages include patient compliance and consumer preference, improved bioavailability, speed of product development in many cases, shortened manufacturing time, enhanced drug stability due to less exposure of the active ingredient to oxygen, excellent dose uniformity, and product differentiation.
  • In another embodiment, the nutritional supplements may include multiple vitamins, nutrients and minerals in more than one composition. In a specific embodiment, various active ingredients may be incorporated into multiple compositions as a kit. In one example, fat soluble compounds such as omega 3 fatty acids, may be included in one composition, whereas water soluble vitamins such as B-complex vitamins and vitamin C may be separated into another composition. In another example, the multiple compositions may be separated due to size or the large dosage amounts of specific ingredients. In another example, the nutritional supplementation of a multivitamin may not be adequate in one composition. Accordingly, all the active ingredients may be divided into a total of two compositions, three compositions, four compositions and five composition. In one embodiment, each composition may have equal amounts of each active ingredient. In another embodiment, compositions may have unequal amounts of various active ingredients, or merely supplemental amounts of specific active ingredients.
  • In another specific embodiment, the composition, kits and methods may be used as a dietary supplement. In another embodiment, the composition, kits and methods may be used as a prescription prenatal vitamin. In another embodiment, the compositions, kits and methods of the present invention, may be administered to a patient, such as a woman during pregnancy, prenatal or who is breast-feeding. In another embodiment, the compositions, kits and methods of the present invention may be utilized or administered, once a day, twice a day, three times a day, four times a day and five times a day. When multiple compositions are provided in a kit, the compositions may be co-administered at the same or administered separately.
  • The compositions, kits and methods of the present invention may be used or utilized in one or more dosage forms. In a specific embodiment, the dosage form more be a capsule, tablet, caplet, gel caplet (gelcap), syrup, a liquid composition, a concentrated powder, and a concentrated powder admixed with a liquid. The kits may comprise multiple compositions utilizing multiple dosage forms.
  • The ingredients of the present invention may thus be combined into a composition which may be in the form of capsule, tablet, caplet, gel caplet (gelcap), syrup, a liquid composition, a concentrated powder, and a concentrated powder admixed with a liquid, and which may be administered alone or in suitable combination with other components. For example, the composition of the present invention may be administered in one or more caplets or gel caps as practical for ease of administration. Each of the vitamins, nutrients and minerals is commercially available, and can be blended to form a single composition or can form multiple compositions, which may be co-administered. In a specific embodiment one or more of the compositions may be in the dosage form of a gelcap.
  • To prepare the compositions of the present invention, each of the active ingredients may be combined in intimate admixture with a suitable carrier according to conventional compounding techniques. The carrier may take a wide variety of forms depending upon the form of the preparation desired for administration, e.g., oral, sublingual, nasal, topical patch, or parenteral.
  • In preparing the composition in oral dosage form, any of the usual media may be utilized. For liquid preparations (e.g., suspensions, elixirs, and solutions), media containing, for example water, oils, alcohols, flavoring agents, preservatives, coloring agents and the like may be used. Pharmaceutical acceptable carriers such as starches, sugars, diluents, granulating agents, lubricants, binders, disintegrating agents and the like may be used to prepare oral solids (e.g., powders, caplets, pills, tablets, capsules, and lozenges). Controlled release forms may also be used. Because of their ease in administration, caplets, tablets, pills, and capsules represent the most advantageous oral dosage unit form, in which case solid carriers are employed. If desired, tablets may be sugar coated or enteric coated by standard techniques. All of these pharmaceutical carriers and formulations are well known to those of ordinary skill in the art. See, e.g., WADE & WALLER, HANDBOOK OF PHARMACEUTICAL EXCIPIENTS (2nd ed. 1994).
  • In a specific mode of administration, the dosage forms, may be swallowable, chewable or dissolvable.
  • Swallowable compositions are well known in the art and are those that do not readily dissolve when placed in the mouth and may be swallowed whole without any chewing or discomfort. In a specific embodiment of the present invention the swallowable compositions may have a shape containing no sharp edges and a smooth, uniform and substantially bubble free outer coating.
  • To prepare the swallowable compositions of the present invention, each of the active ingredients may be combined in intimate admixture with a suitable carrier according to conventional compounding techniques. In a specific embodiment of the swallowable compositions of the present invention, the surface of the compositions may be coated with a polymeric film. Such a film coating has several beneficial effects. First, it reduces the adhesion of the compositions to the inner surface of the mouth, thereby increasing the patient's ability to swallow the compositions. Second, the film may aid in masking the unpleasant taste of certain drugs. Third, the film coating may protect the compositions of the present invention from atmospheric degradation. Polymeric films that may be used in preparing the swallowable compositions of the present invention include vinyl polymers such as polyvinylpyrrolidone, polyvinyl alcohol and acetate, cellulosics such as methyl and ethyl cellulose, hydroxyethyl cellulose and hydroxylpropyl methylcellulose, acrylates and methacrylates, copolymers such as the vinyl-maleic acid and styrene-maleic acid types, and natural gums and resins such as zein, gelatin, shellac and acacia Pharmaceutical carriers and formulations for swallowable compounds are well known to those of ordinary skill in the art. See generally, e.g., WADE & WALLER, HANDBOOK OF PHARMACEUTICAL EXCIPIENTS (2nd ed. 1994).
  • Chewable compositions are those that have a palatable taste and mouthfeel, are relatively soft and quickly break into smaller pieces and begin to dissolve after chewing such that they are swallowed substantially as a solution.
  • In order to create chewable compositions, certain ingredients should be included to achieve the attributes just described. For example, chewable compositions should include ingredients that create pleasant flavor and mouthfeel and promote relative softness and dissolvability in the mouth. The following discussion describes ingredients that may help to achieve these characteristics.
  • Chewable compositions preferably have a pleasant or palatable flavor and a pleasant mouthfeel. A variety of ingredients can be included in the compositions of the present invention to enhance mouthfeel.
  • In the chewable compositions of the present invention, sugars such as white sugar, corn syrup, sorbitol (solution), maltitol (syrup), oligosaccharide, isomaltooligosaccharide, sucrose, fructose, lactose, glucose, lycasin, xylitol, lactitol, erythritol, mannitol, isomaltose, dextrose, polydextrose, dextrin, compressible cellulose, compressible honey, compressible molasses and mixtures thereof may be added to improve mouthfeel and palatability. Further, by way of example and without limitation, fondant or gums such as gelatin, agar, arabic gum, guar gum, and carrageenan may be added to improve the chewiness of the compositions. Fatty materials that may be included in the present invention include, by way of example and without limitation, vegetable oils (including palm oil, palm hydrogenated oil, corn germ hydrogenated oil, castor hydrogenated oil, cotton-seed oil, olive oil, peanut oil, palm olein oil, and palm stearin oil), animal oils (including refined oil and refined lard whose melting point ranges from 30° to 42° C.), Cacao fat, margarine, butter, and shortening.
  • Alkyl polysiloxanes (commercially available polymers sold in a variety of molecular weight ranges and with a variety of different substitution patterns) also may be used in the present invention to enhance the texture, the mouthfeel, or both of the chewable nutritional supplement compositions described herein. By “enhance the texture” it is meant that the alkyl polysiloxane improves one or more of the stiffness, the brittleness, and the chewiness of the chewable supplement, relative to the same preparation lacking the alkyl polysiloxane. By “enhance the mouthfeel” it is meant that the alkyl polysiloxane reduces the gritty texture of the supplement once it has liquefied in the mouth, relative to the same preparation lacking the alkyl polysiloxane.
  • Alkyl polysiloxanes generally comprise a silicon and oxygen-containing polymeric backbone with one or more alkyl groups pending from the silicon atoms of the back bone. Depending upon their grade, they can further comprise silica gel. Alkyl polysiloxanes are generally viscous oils. Exemplary alkyl polysiloxanes that can be used in the swallowable, chewable or dissolvable compositions of the present invention include, by way of example and without limitation, monoalkyl or dialkyl polysiloxanes, wherein the alkyl group is independently selected at each occurrence from a C1-C6-alkyl group optionally substituted with a phenyl group. A specific alkyl polysiloxane that may be used is dimethyl polysiloxane (generally referred to as simethicone). More specifically, a granular simethicone preparation designated simethicone GS may be used. Simethicone GS is a preparation which contains 30% simethicone USP. Simethicone USP contains not less than about 90.5% by weight (CH3)3—Si{OSi(CH3)2}CH3 in admixture with about 4.0% to about 7.0% by weight SiO2.
  • Chewable compositions should begin to break and dissolve in the mouth shortly after chewing begins such that the compositions can be swallowed substantially as a solution. The dissolution profile of chewable compositions may be enhanced by including rapidly water-soluble fillers and excipients. Rapidly water-soluble fillers and excipients preferably dissolve within about 60 seconds of being wetted with saliva. Indeed, it is contemplated that if enough water-soluble excipients are included in the compositions of the present invention, they may become dissolvable rather than chewable composition forms. Examples of rapidly water soluble fillers suitable for use with the present invention include, by way of example and without limitation, saccharides, amino acids and the like. Disintegrants also may be included in the compositions of the present invention in order to facilitate dissolution. Disintegrants, including permeabilising and wicking agents, are capable of drawing water or saliva up into the compositions which promotes dissolution from the inside as well as the outside of the compositions. Such disintegrants, permeabilising and/or wicking agents that may be used in the present invention include, by way of example and without limitation, starches, such as corn starch, potato starch, pre-gelatinized and modified starches thereof, cellulosic agents, such as Ac-di-sol, montrnorrilonite clays, cross-linked PVP, sweeteners, bentonite, microcrystalline cellulose, croscarmellose sodium, alginates, sodium starch glycolate, gums, such as agar, guar, locust bean, karaya, pectin, Arabic, xanthan and tragacanth, silica with a high affinity for aqueous solvents, such as colloidal silica, precipitated silica, maltodextrins, beta-cyclodextrins, polymers, such as carbopol, and cellulosic agents, such as hydroxymethylcellulose, hydroxypropylcellulose and hydroxyopropylmethylcellulose.
  • Finally, dissolution of the compositions may be facilitated by including relatively small particles sizes of the ingredients used.
  • In addition to those described above, any appropriate fillers and excipients may be utilized in preparing the swallowable, chewable and/or dissolvable compositions of the present invention so long as they are consistent with the objectives described herein. For example, binders, are substances used to cause adhesion of powder particles in granulations. Such compounds appropriate for use in the present invention include, by way of example and without limitation, acacia, compressible sugar, gelatin, sucrose and its derivatives, maltodextrin, cellulosic polymers, such as ethylcellulose, hydroxypropylcellulose, hydroxypropylmethyl cellulose, carboxymethylcellulose sodium and methylcellulose, acrylic polymers, such as insoluble acrylate ammoniomethacrylate copolymer, polyacrylate or polymethacrylic copolymer, povidones, copovidones, polyvinylalcohols, alginic acid, sodium alginate, starch, pregelatinized starch, guar gum, polyethylene glycol and others known to those of ordinary skill in the art.
  • Diluents also may be included in the compositions of the present invention in order to enhance the granulation of the compositions. Diluents can include, by way of example and without limitation, microcrystalline cellulose, sucrose, dicalcium phosphate, starches, lactose and polyols of less than 13 carbon atoms, such as mannitol, xylitol, sorbitol, maltitol and pharmaceutically acceptable amino acids, such as glycin, and their mixtures.
  • Lubricants are substances used in composition formulations that reduce friction during composition compression. Lubricants that may be used in the present invention include, by way of example and without limitation, stearic acid, calcium stearate, magnesium stearate, zinc stearate, talc, mineral and vegetable oils, benzoic acid, poly(ethylene glycol), glyceryl behenate, stearyl futmarate, and others known to those of ordinary skill in the art.
  • Glidants improve the flow of powder blends during manufacturing and minimize composition weight variation. Glidants that may be used in the present invention include, by way of example and without limitation, silicon dioxide, colloidal or fumed silica, magnesium stearate, calcium stearate, stearic acid, cornstarch, talc and others known to those of ordinary skill in the art.
  • Colorants also may be included in the nutritional supplement compositions of the present invention. As used herein, the term “colorant” includes compounds used to impart color to pharmaceutical preparations. Such compounds include, by way of example and without limitation, FD&C Red No. 3, FD&C Red No. 20, FD&C Yellow No. 6, FD&C Blue No. 2, D&C Green No. 5, FD&C Orange No. 5, D&C Red No. 8, caramel, and ferric oxide, red and others known to those of ordinary skill in the art. Coloring agents also can include pigments, dyes, tints, titanium dioxide, natural coloring agents, such as grape skin extract, beet red powder, beta carotene, annato, carmine, turneric, paprika and others known to those of ordinary skill in the art. It is recognized that no colorant is required in the nutritional supplement compositions described herein.
  • If desired, the compositions of the present invention may be sugar coated or enteric coated by standard techniques. The unit dose forms may be individually wrapped, packaged as multiple units on paper strips or in vials of any size, without limitation. The swallowable, chewable or dissolvable compositions of the present invention may be packaged in unit dose, rolls, bulk bottles, blister packs and combinations thereof, without limitation.
  • The swallowable, chewable or dissolvable compositions of the present invention may be prepared using conventional methods and materials known in the pharmaceutical art. For example, U.S. Pat. Nos. 5,215,754 and 4,374,082 relate to methods for preparing swallowable compositions. U.S. Pat. No. 6,495,177 relates to methods to prepare chewable nutritional supplements with improved mouthfeel. U.S. Pat. No. 5,965,162, relates to kits and methods for preparing multi-vitamin comestible units which disintegrate quickly in the mouth, especially when chewed. Further, all pharmaceutical carriers and formulations described herein are well known to those of ordinary skill in the art, and determination of workable proportions in any particular instance will generally be within the capability of the person skilled in the art. Details concerning any of the excipients of the invention may be found in WADE & WALLER, HANDBOOK OF PHARMACEUTICAL EXCIPIENTS (2nd ed. 1994). AU active ingredients, fillers and excipients are commercially available from companies such as Aldrich Chemical Co., FMC Corp, Bayer, BASF, Alexi Fres, Witco, Mallinckrodt, Rhodia, ISP, and others.
  • A specific embodiment of the present invention may comprise kits or swallowable compositions packaged in blister packs. Blister packs as packaging for swallowable compositions are well known to those of ordinary skill in the art. Blister packs may be made of a transparent plastic sheet which as been formed to carry a matrix of depression or blisters. One or more swallowable compositions are received in each depression or blister. A foil or plastic backing is then adhered across the plane of the sheet sealing the swallowable compositions in their respective blisters. Examples of materials used for the blister packs include, but are not limited to, aluminum, paper, polyester, PVC, and polypropylene. Alternative materials are known to those of ordinary skill in the art. To remove a swallowable composition, the depression material is pressed in and the composition is pushed through the backing material. Multiple blister packs may be placed in an outer package, often a box or carton for sale and distribution.
  • Another specific embodiment of the present invention may comprise kits or swallowable compositions packaged in bottles. The bottle may be glass or plastic in form with a pop or screw top cap. Bottle packaging for compositions in swallowable form are well known to those of ordinary skill in the art.
  • Additionally, the unit dose forms may be individually wrapped, packaged as multiple units on paper strips or in vials of any size, without limitation. The swallowable, chewable or dissolvable compositions of the invention may be packaged in unit dose, rolls, bulk bottles, blister packs and combinations thereof, without limitation.
  • Other objectives, features and advantages of the present invention will become apparent from the following specific examples. The specific examples, while indicating specific embodiments of the invention, are provided by way of illustration only. Accordingly, the present invention also includes those various changes and modifications within the spirit and scope of the invention that may become apparent to those skilled in the art from this detailed description. The invention will be further illustrated by the following non-limiting examples.
  • Without further elaboration, it is believed that one skilled in the art, using the preceding description, can utilize the present invention to the fullest extent. The following examples are illustrative only, and not limiting of the remainder of the disclosure in any way whatsoever.
  • Example 1
  • A composition of the following formulation was prepared in gel-cap form, including the appropriate excipients, by standard methods known to those of ordinary skill in the art:
  • Vitamin A (Beta Carotene) 1100 IU
    Vitamin C 30 mg
    Vitamin D (Vitamin D3) 1000 IU
    Vitamin E 20 IU
    Vitamin B1 1.6 mg
    Vitamin B2 (Riboflavin) 1.8 mg
    Vitamin B3 (Niacinamide) 15 mg
    Vitamin B6 2.5 mg
    Vitamin B9 (Folic Acid) 1 mg
    Vitamin B12 12 μg
    Iron 29 mg
    Magnesium 20 mg
    Zinc 25 mg
    Copper 2.0 mg
    Iodine 150 μg
    DHA 200 mg
  • Example 2
  • In another example, various active ingredients may be incorporated into multiple compositions as a kit. In this non-limiting example, a first composition of the following formulation is prepared in caplet form, including the appropriate excipients, by standard methods known to those of ordinary skill in the art:
  • Vitamin A (Beta Carotene) 1100 IU
    Vitamin C 30 mg
    Vitamin D (Vitamin D3) 1000 IU
    Vitamin E 20 IU
    Vitamin B1 1.6 mg
    Vitamin B2 (Riboflavin) 1.8 mg
    Vitamin B3 (Niacinamide) 15 mg
    Vitamin B6 2.5 mg
    Vitamin B9 (Folic Acid) 1 mg
    Vitamin B12 12 μg
    Iron 29 mg
    Magnesium 20 mg
    Zinc 25 mg
    Copper 2.0 mg
    Iodine 150 μg
  • A second composition of the following formulation is prepared in gel-cap form by standard methods known to those of ordinary skill in the art:
  • DHA 200 mg
  • Example 3
  • In another example, various active ingredients may be divided into multiple compositions or a kit. In this non limiting example, the active ingredients of the composition of Example 1 may be divided into multiple compositions or kits. In this non limiting example, a first composition of the following formulation is prepared in gel-cap form, including the appropriate excipients, by standard methods known to those of ordinary skill in the art:
  • Vitamin A (Beta Carotene) 550 IU
    Vitamin C 15 mg
    Vitamin D (Vitamin D3) 500 IU
    Vitamin E 10 IU
    Vitamin B1 0.8 mg
    Vitamin B2 (Riboflavin) 0.9 mg
    Vitamin B3 (Niacinamide) 7.5 mg
    Vitamin B6 1.25 mg
    Vitamin B9 (Folic Acid) 0.5 mg
    Vitamin B12 6.0 μg
    Iron 14.5 mg
    Magnesium 10 mg
    Zinc 12.5 mg
    Copper 1.0 mg
    Iodine 75 μg
    DHA 100 mg
  • A second composition of the following formulation is prepared in gel-cap form by standard methods known to those of ordinary skill in the art:
  • Vitamin A (Beta Carotene) 550 IU
    Vitamin C 15 mg
    Vitamin D (Vitamin D3) 500 IU
    Vitamin E 10 IU
    Vitamin B1 0.8 mg
    Vitamin B2 (Riboflavin) 0.9 mg
    Vitamin B3 (Niacinamide) 7.5 mg
    Vitamin B6 1.25 mg
    Vitamin B9 (Folic Acid) 0.5 mg
    Vitamin B12 6.0 μg
    Iron 14.5 mg
    Magnesium 10 mg
    Zinc 12.5 mg
    Copper 1.0 mg
    Iodine 75 μg
    DHA 100 mg
  • Example 4
  • A study is undertaken to evaluate the effectiveness of the compositions of the present invention in the treatment of patients. The objective of the study is to determine whether oral intake of the compositions results in an improvement of the nutritional status of patients with regard to the specific vitamins and minerals contained in the administered compositions.
  • A double-blind, placebo controlled study is conducted over a six-month period. A total of 120 subjects (60 pregnant women entering the second trimester of pregnancy and 60 lactating women), aged 20-35 years, are chosen for the study. An initial assessment of the nutritional status of each woman is conducted. Vitamin A and vitamin B6 are measured using high performance liquid chromatography. Erythrocyte transketolase activity is used to measure vitamin B1 levels. Vitamin B2 levels are determined by assessment of erythrocyte glutathione reductase activity. Vitamin B3 levels are assessed by measuring urinary excretion of N′methylnicotinamide and its pyridone. Vitamin B9 is measured by radioimmunoassay (RIA), specifically The Solid Phase No Biol Folic Acid Kit (Diagnostic Products, Los Angeles, Calif.). Vitamin B12 is measured by RIA using human intrinsic factor as a binder. Vitamin C levels are measured by spectrophotometric and colorimetric methods. Vitamin D is measured using an extraction double-antibody RIA (Dia Sorin, Inc., Stillwater, Minn.). The peroxide hemolysis test is used to determine vitamin E status. Iron levels are measured using standard spectrophotometry. Iodine levels are measured by HPLC. Magnesium levels are measured by absorbance of a magnesium chelate with xylidl blue at 660 nM. Zinc levels are assessed using flame atomic absorption spectrometry (Perkins Elmer 460, Norwalk, Conn.). DHA is measured and quantified using gas chromatography procedures.
  • Additionally, total serum homocysteine levels are determined by extraction on the Multi-Prep® gravity series GVSA-100 column, a strong anion exchange gravity flow column, and measurement by gas chromatography/mass spectrometry. Biochemical Diagnostics, Austin, Tex.
  • The 120 subjects are separated into four separate groups of 30 women. In a first group comprising only pregnant women and in a second group comprising only lactating women, each subject is administered one dosage form of the composition as described in Example 1 once a day. In a third group comprising only pregnant women and in a fourth group comprising only lactating women, each subject is administered one placebo dosage form once a day. Thus, dosage form administration occurs every 24 hours. No other nutritional supplements are taken by the subjects during the assessment period.
  • An assessment of the nutritional status of each woman is conducted utilizing the methods described above at one month intervals for a six month period. The data is evaluated using multiple linear regression analysis and a standard t-test. In each analysis, the baseline value of the outcome variable is included in the model as a covariant. Treatment by covariant interaction effects is tested by the method outlined by Weigel & Narvaez, 12 CONTROLLED CLINICAL TRIALS 378-94 (1991). If there are no significant interaction effects, the interaction terms are removed from the model. The regression model assumptions of normality and homogeneity of variance of residuals are evaluated by inspection of the plots of residuals versus predicted values. Detection of the temporal onset of effects is done sequentially by testing for the presence of significant treatment effects at 1, 2, 3, 4, 5, and 6 months, proceeding to the earlier time in sequence only when significant effects have been identified at each later time period. Changes from the baseline within each group are evaluated using paired t-tests. In addition, analysis of variance is performed on all baseline measurements and measurable subject characteristics to assess homogeneity between groups. All statistical procedures are conducted using the Statistical Analysis System (SAS Institute Inc., Cary, N.C.). An alpha level of 0.05 is used in all statistical tests.
  • An unexpected statistically significant improvement in the nutritional status of vitamin, mineral, and nutrient levels measured is observed in the treated subjects over the controls upon completion of the study. Specifically, homocysteine levels in women receiving supplements remain unelevated. Therefore, the study confirms that oral administration of the compositions of the present invention is effective in improving the nutritional status of patients. Other unexpected results relate to the observation that the length of gestation is increased by approximately six days in women receiving supplements, due to DHA intake, and their homocysteine levels are not elevated, due to folic acid intake, leading to a better prognosis regarding risk of neural tube defects in their infants.
  • Example 5
  • A study is undertaken testing supplementation of iodine, and vitamin D. A study is conducted over a three-month period. A total of 120 subjects (pregnant women entering the second trimester of, aged 20-35 years, are chosen for the study) An initial assessment of the nutritional status of each woman for iodine, and vitamin D is conducted as provided in Example 4.
  • In the first group, each subject is administered 1 gelcap daily, with the composition as described in Example 1. In the second group, each subject is administered 1 one caplet daily that includes the following ingredients in the listed amounts (control):
  • Vitamin A (acetate) 1100 IU
    Beta Carotene 600 IU
    Vitamin B1 (thiamine mononitrate) 1.6 mg
    Vitamin B2 (riboflavin) 1.8 mg
    Vitamin B3 (niacinamide) 15 mg
    Vitamin B6 (pyridoxine hydrochloride) 2.5 mg
    Vitamin B9 (folic acid) 1000 μg
    Vitamin B12 (cyanocobalamin) 5 μg
    Vitamin C (ascorbic acid) 60 mg
    Vitamin D (cholecalciferol) 400 IU
    Vitamin E (d-alpha-tocopheryl acetate) 30 IU
    Iron (polysaccharide complex) 29 mg
    Magnesium (magnesium oxide) 25 mg
    Zinc (zinc oxide) 15 mg
  • An assessment of nutritional status for each subject is measured at one-month intervals for a six month period. Specifically, in regard to vitamin D deficiency, the serum levels of 25-hydroxyvitamin D are measured to assess if they meet levels as high as 30 ng/ml or are increasing towards a level of 30 ng/ml. The data is evaluated using multiple linear regression analysis and a standard students t-test. In each analysis the baseline value of the outcome variable is included in the model as a covariant. Treatment by covariant interaction effects is tested by the method outlined by Weigel & Narvaez, 12 CONTROLLED CLINICAL TRIALS 378-94 (1991). If there are no significant interaction effects, the interaction terms are removed from the model. The regression model assumptions of normality and homogeneity of variance of residuals are evaluated by inspection of the plots of residuals versus predicted values. Detection of the temporal onset of effects is done sequentially by testing for the presence of significant treatment effects at 16, 12, and 8 weeks, proceeding to the earlier time in sequence only when significant effects have been identified at each later time period. Changes from the baseline within each group are evaluated using paired t-tests. In addition, analysis of variance is performed on all baseline measurements and measurable subject characteristics to assess homogeneity between groups. All statistical procedures are conducted using the Statistical Analysis System (SAS Institute Inc., Cary, N.C.). An alpha level of 0.05 is used in all statistical tests.
  • A statistically significant improvement in the nutritional status is preferably observed in the treated subjects who were administered the composition of Example 1 over treated subjects who are administered the controls. Specifically, in regard to vitamin D supplementation, the tested serum levels of 25-hydroxyvitamin D are preferably in the range of 30 ng/ml for treated subjects. Specifically, in regard to iodine content, serum levels show an increased level of iodide levels; whereas the control shows not increased iodide serum level.
  • While specific embodiments of the present invention have been described, other and further modifications and changes may be made without departing from the spirit of the invention. All further and other modifications and changes are included that come within the scope of the invention as set forth in the claims. The disclosure of each publication cited above is expressly incorporated by reference in its entirety to the same extent as if each were incorporated by reference individually.

Claims (30)

1. A composition consisting of vitamin D, iodine, vitamin B1, vitamin B6, vitamin B12, vitamin B2, vitamin B9, vitamin B3, vitamin E, vitamin A, vitamin C, iron, zinc, copper, magnesium, omega-3 fatty acids and one or more pharmaceutically acceptable carriers.
2. The composition of claim 1, wherein said vitamin D is in the form selected from one or more of the group consisting of vitamin D3, vitamin D2, previtamin D2, ergosterol, calcitriol, 7-dehydrocholesterol, Vitamin D1, vitamin D4, vitamin, 7-dehydrositosterol, Lumisterol, 25-hydroxyvitamin D, all steroids that exhibit the biological activity of calciol, 25-fluorocalciol, (3S)-3-amino-3-deoxycalciol, 11α-acetoxycalciol, calcidiol, ercalcitriol, calcitetrol, tacalciol, (5E)-isocalciol, Dihydroercalciol, (1S)-Hydroxycalciol, (24R)-Hydroxycalcidiol, Ercalcidiol, Ercalcitriol, Ertacalciol, (5E)-(10S)-10,19-Dihydroercalciol, (6Z)-Tacalciol, and (22E)-(24R)-Ethyl-22,23-didehydrocalciol;
wherein said vitamin B1 is in the form selected from one or more of the group consisting of thiamine, thiamine mononitrate, thiamine monophosphate, thiamine diphosphate, thiamine triphosphate, acetiamine, allithiamine, prosultiamine and S-acyl derivatives of thiamine such as benfotiamine, fursultiamine and salts and esters thereof;
wherein said vitamin A is in the form selected from one or more of the group consisting of retinol acetate, retinol, retinol palmitate, retinoic acid, retinal, beta-cryptoxanthin, alpha-carotene, beta-carotene, gamma-carotene, and provitamin A carotenoids;
wherein said vitamin B9 is in the form selected from one or more of the group consisting of folic acid, folinic acid, folacin, metafolin, and/or one or more natural isomers of folate including (6S)-tetrahydrofolic acid or a polyglutamyl derivative thereof, (6S,R)-tetrahydrofolic acid or a polyglutamyl derivative thereof, 5-methyl-(6S)-tetrahydrofolic acid or a polyglutamyl derivative thereof, 5-methyl-(6S,R)-tetrahydrofolic acid or a polyglutamyl derivative thereof, 5-formyl-(6S)-tetrahydrofolic acid or a polyglutamyl derivative thereof, 10-formyl-(6R)-tetrahydrofolic acid or a polyglutamyl derivative thereof, 5,10-methylene-(6R)-tetrahydrofolic acid or a polyglutamyl derivative thereof, 5,10-methenyl-(6R)-tetrahydrofolic acid or a polyglutamyl derivative thereof and 5-formimino-(6S)-tetrahydrofolic acid or a polyglutamyl derivative thereof and their salts and esters thereof;
wherein said vitamin B2 is in the form selected from one or more of the group consisting of flavin mononucleotide (FMN), flavin adenine dinucleotide (FAD), riboflavin (also known as 7,8-dimethyl-10-((2R,3R,4S)-2,3,4,5-tetrahydroxypentyl)benzo[g]pteridine-2,4 (3H,10H)-dione or lactoflavin) and riboflavin derivatives such as riboflavin-5′-monophosphate, riboflavin-5′-monobutyrate and riboflavin-5′-monopalmitate;
wherein said vitamin B3 is in the form selected from one or more of the group consisting of niacin, and nicotinamide and salts and esters thereof;
wherein said vitamin B6 is in the form selected from one or more of the group consisting of pyridoxine, 3-hydroxy-4,5-bis(hydroxymethyl)-2-methylpyridine, 5′-deoxypyridoxal, 2-demethylpyridoxal(2-norpyridoxal), 2-propyl-2-norpyridoxal (2′-ethylpyridoxal), 6-methylpyridoxal, 2′-hydroxypyridoxal (2-hydroxymethyl-2-demethylpyridoxal or 2-hydroxymethyl-2-norpyridoxal), 4′-deoxypyridoxine 5′-phosphate, 5′-methylpyridoxal-5′-phosphate, pyridoxal N-oxide 5′-phosphate, Pyridoxal, Pyridoxamine, Pyridoxine-5′-phosphate (PNP), pyridoxal-5′-phosphate (PLP) and pyridoxamine-5′-phosphate (PMP), and their salts and chelates thereof;
wherein said vitamin B12 is in the form selected from one or more of the group consisting of cobalamin, methylcobalamin, 5′-deoxyadenosylcobalamin, cyanocobalamin, hydroxycobalamin and mecobalamin;
wherein said vitamin E is in the form selected from one or more of the group consisting of alpha, beta, gamma, and delta tocopherols in its natural or synthetic (dl) forms; alpha, beta, gamma, and delta tocotrienols in its natural or synthetic (dl) forms, dl-alpha tocopheryl derivatives such as dl-alpha tocopheryl esters, dl-alpha-tocopheryl acetate or succinate and d-alpha-tocopheryl acetate or dl-alpha tocopheryl phosphates;
wherein said vitamin C is in the form selected from one or more of the group consisting of ascorbic acid, asorbates, calcium ascorbate, sodium ascorbate, dehydroascorbic acid and salts, ascorbyl palmitate, ascorbyl phosphates and salts, ascorbyl sulfates and salts, acylated ascorbic acid derivatives, 6-bromo-6-deoxy-L-ascorbic acid, and ascorbate salts;
wherein said iron is in the form selected from one or more of the group consisting of elemental iron, in the form of a salt, chelated form, non-chelated form, chelated to an amino acid, carbonyl iron, ferrous gluconate, ferrous fumarate, polysaccharide iron complex, elemental polysaccharide iron, polysaccharide iron, ferrous (II)-bis-glycinate chelate, ferrous asparto glycinate, ferrous bisglycinate, ferrous bisglycinate hydrochloride, ferrous bisglycinate, elemental ferrous bisglycinate, ferrous sulfate, ferronyl (micronized), as Iron Aid, iron protein succinylate, carbonyl iron, Sumalate iron, Heme iron complex, as Ferrochel amino acid chelate, Heme iron polypeptide as Proferrin-bovine source, as heme iron polypeptide (bovine source) as sodium iron EDTA (Ferrazone), ferric ammonium citrate, elemental iron, and ferric pyrophosphate;
wherein said zinc is in the form selected from one or more of the group consisting of elemental zinc, in the form of a salt, in a chelated form, in a non-chelated form, zinc acetate, zinc gluconate, zinc picolinate, zinc sulfate and zinc oxide;
wherein said copper is in the form selected from one or more of the group consisting of elemental copper, in the form of a salt, in a chelated form, in a non-chelated form, cupric oxide, copper sulfate, copper gluconate, copper citrate, cupric acetate, and alkaline copper carbonate;
wherein said magnesium is in the form selected from one or more of the group consisting of elemental magnesium, in the form of a salt, in a chelated form, in a non-chelated form, magnesium acetate, magnesium carbonate, magnesium gluconate, magnesium chloride, magnesium citrate, magnesium silicate, magnesium stearate, magnesium sulfate, magnesium oxide, and magnesium chelated to an amino acid;
wherein said omega 3 fatty acids is in the form selected from one or more of the group consisting docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA) and a-linolenic acid (ALA); and
wherein said iodine is in the form selected from one or more of the group consisting of iodide, elemental iodine, iodized salt, Lugol's iodine, sodium iodide, potassium iodide, potassium iodate, nascent iodine, and Nano-Colloidal Detoxified Iodine.
3. The composition of claim 1, wherein said vitamin D is in the form of vitamin D3 and is present in an amount of about 1000 I.U. or 25 μg.
4. The composition of claim 1, wherein said iodine is present in an amount of about 150 μg.
5. The composition of claim 1, wherein said vitamin B1 is present in an amount of about 1.6 mg.
6. The composition of claim 1, wherein said vitamin B6 is present in an amount of about 2.5 mg.
7. The composition of claim 1, wherein said vitamin B12 is present in an amount of about 12 μg.
8. The composition of claim 1, wherein said vitamin B2 is present in an amount of about 1.8 mg.
9. The composition of claim 1, wherein said vitamin B9 is present in an amount of about 1.0 mg.
10. The composition of claim 1, wherein said vitamin E is present in an amount of about 20 I.U.
11. The composition of claim 1, wherein said vitamin A is in the form of beta carotene and is present in an amount of about 1100 I.U. or about 660 μg.
12. The composition of claim 1, wherein said vitamin C is present in an amount of about 30 mg.
13. The composition of claim 1, wherein said vitamin B3 is in the form of nicotinamide and is present in an amount of about 15 mg.
14. The composition of claim 1, wherein said iron is present in an amount of about 29 mg.
15. The composition of claim 1, wherein said zinc is present in an amount of about 25 mg.
16. The composition of claim 1, wherein said copper is present in an amount of about 1.0 mg to about 3.0 mg.
17. The composition of claim 1, wherein said copper is present in an amount of about 2.0 mg.
18. The composition of claim 1, wherein said magnesium is present in an amount of about 20 mg.
19. The composition of claim 1, wherein said omega 3 fatty acids comprises DHA and is present in an amount of about 200 mg.
20. The composition of claim 1, wherein said vitamin D is present in an amount of about 500 I.U. to about 1500 I.U., said iodine is present in an amount of about 75 μg to about 225 μg, said vitamin B1 is present in an amount of about 0.8 mg to about 2.4 mg, said vitamin B6 is present in an amount of about 1.2 mg to about 3.8 mg, said vitamin B12 is present in an amount of about 6 μg to about 18 μg, said vitamin B2 is present in an amount of about 0.9 mg to about 2.7 mg, said vitamin B9 is present in an amount of about 0.5 mg to about 1.5 mg, said vitamin E is present in an amount of about 10 I.U. to about 30 I.U., said vitamin A is present in an amount of about 550 I.U. to about 1650 I.U., said vitamin C is present in an amount of about 15 mg to about 45 mg, said vitamin B3 is present in an amount of about 7.5 mg to about 22.5 mg, said iron is present in an amount of about 14.5 mg to about 43.5 mg, said zinc is present in an amount of about 12.5 mg to about 37.5 mg, said copper is present in an amount of about 1.0 mg to about 3.0 mg, said magnesium is present in an amount of about 10 mg to about 30 mg, and said omega 3 fatty acids is present in an amount of about 100 mg to about 300 mg.
21. (canceled)
22. The composition of claim 1, wherein said dosage form is a gelcap.
23. The composition of claim 22, wherein the said dosage form is a liquid gelcap.
24. The composition of claim 1, wherein said omega-3 fatty acids comprises DHA, and wherein the source of DHA is algae oil.
25. The composition of claim 24, wherein the source of the algae oil is microalgae Crypthecodinium cohnii.
26. The composition of claim 1, wherein said pharmaceutically acceptable carriers include one or more selected from the group consisting of gelatin, sorbitol, glycerin, soybean oil, beeswax, dicalcium phosphate, lecithin oil, vegetable oil, and colorants.
27. The composition of claim 1, wherein said composition does not contain fish oils.
28. A method comprising providing vitamin, mineral, and omega-3 fatty acid supplementation to a patient in need thereof, wherein said method comprises administering a composition according to claim 1 to said patient.
29. The method of claim 28, wherein said patient is a female human, and said composition is administered to said female human before pregnancy, during pregnancy, after pregnancy, while breast-feeding, or a combination thereof.
30. The method of claim 28, wherein said composition is administered once daily.
US13/475,182 2011-07-07 2012-05-18 Compositions, kits and methods for nutrition supplementation Abandoned US20130011377A1 (en)

Priority Applications (4)

Application Number Priority Date Filing Date Title
US13/475,182 US20130011377A1 (en) 2011-07-07 2012-05-18 Compositions, kits and methods for nutrition supplementation
US15/343,599 US20170112178A1 (en) 2011-07-07 2016-11-04 Compositions, kits and methods for nutrition supplementation
US17/534,817 US20220079201A1 (en) 2011-07-07 2021-11-24 Compositions, kits and methods for nutrition supplementation
US17/750,969 US20220279831A1 (en) 2011-07-07 2022-05-23 Compositions, kits and methods for nutrition supplementation

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201161505341P 2011-07-07 2011-07-07
US13/292,735 US8183227B1 (en) 2011-07-07 2011-11-09 Compositions, kits and methods for nutrition supplementation
US13/475,182 US20130011377A1 (en) 2011-07-07 2012-05-18 Compositions, kits and methods for nutrition supplementation

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
US13/292,735 Continuation US8183227B1 (en) 2011-07-07 2011-11-09 Compositions, kits and methods for nutrition supplementation

Related Child Applications (1)

Application Number Title Priority Date Filing Date
US15/343,599 Continuation US20170112178A1 (en) 2011-07-07 2016-11-04 Compositions, kits and methods for nutrition supplementation

Publications (1)

Publication Number Publication Date
US20130011377A1 true US20130011377A1 (en) 2013-01-10

Family

ID=46061241

Family Applications (5)

Application Number Title Priority Date Filing Date
US13/292,735 Active US8183227B1 (en) 2011-07-07 2011-11-09 Compositions, kits and methods for nutrition supplementation
US13/475,182 Abandoned US20130011377A1 (en) 2011-07-07 2012-05-18 Compositions, kits and methods for nutrition supplementation
US15/343,599 Abandoned US20170112178A1 (en) 2011-07-07 2016-11-04 Compositions, kits and methods for nutrition supplementation
US17/534,817 Abandoned US20220079201A1 (en) 2011-07-07 2021-11-24 Compositions, kits and methods for nutrition supplementation
US17/750,969 Pending US20220279831A1 (en) 2011-07-07 2022-05-23 Compositions, kits and methods for nutrition supplementation

Family Applications Before (1)

Application Number Title Priority Date Filing Date
US13/292,735 Active US8183227B1 (en) 2011-07-07 2011-11-09 Compositions, kits and methods for nutrition supplementation

Family Applications After (3)

Application Number Title Priority Date Filing Date
US15/343,599 Abandoned US20170112178A1 (en) 2011-07-07 2016-11-04 Compositions, kits and methods for nutrition supplementation
US17/534,817 Abandoned US20220079201A1 (en) 2011-07-07 2021-11-24 Compositions, kits and methods for nutrition supplementation
US17/750,969 Pending US20220279831A1 (en) 2011-07-07 2022-05-23 Compositions, kits and methods for nutrition supplementation

Country Status (1)

Country Link
US (5) US8183227B1 (en)

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103211216A (en) * 2013-04-25 2013-07-24 福建永生活力生物工程有限公司 Health food with function of improving memory in aided manner and preparation method thereof
WO2016113387A1 (en) * 2015-01-15 2016-07-21 Dsm Ip Assets B.V. Combination of 25-hydroxyvitamin d and antioxidants/anti-inflammatories for human nutraceuticals
WO2018102426A1 (en) * 2016-11-29 2018-06-07 University Of Iowa Research Foundation Use of nad precursors for improving maternal health and/or offspring health
US9993457B2 (en) 2014-11-25 2018-06-12 Abbott Laboratories Method of improving visual processing, visual acuity, or both by administering compositions comprising RRR-alpha-tocopherol and carotenoid to infants
US20190008755A1 (en) * 2017-07-07 2019-01-10 H & H Science, Llc Clear skin vitamin
US10517316B2 (en) 2015-01-15 2019-12-31 Dsm Ip Assets B.V. Combination of 25-hydroxyvitamin D and antioxidants/anti-inflammatories for bovine health
WO2020118089A1 (en) * 2018-12-08 2020-06-11 Aphios Corportion Methods and products for treating folic acid deficiency and morning sickness
WO2021108527A1 (en) * 2019-11-25 2021-06-03 Lian xu li Dietary supplement
US11071747B2 (en) 2016-11-29 2021-07-27 University Of Iowa Research Foundation Use of NAD precursors for breast enhancement

Families Citing this family (35)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2129382A4 (en) * 2007-02-21 2011-01-19 Univ Michigan Compositions and methods for tranquilizing heart muscle
JP6311936B2 (en) 2012-02-21 2018-04-18 アルリオン テクノロジーズ, インク. Method and apparatus for deploying and expelling temporary implants in the body
US10182932B2 (en) 2012-02-21 2019-01-22 Allurion Technologies, Inc. Methods and devices for deploying and releasing a temporary implant within the body
WO2014074625A1 (en) * 2012-02-21 2014-05-15 Allurion Technologies, Inc. Anatomically adapted ingestible delivery systems and methods
WO2015040613A1 (en) 2013-09-20 2015-03-26 Care 4 Style Ltd Dietary supplements for treating adhd and related disorders
US9629846B1 (en) 2013-11-14 2017-04-25 Argent Development Group, Llc Nutritional supplements for women desiring to become pregnant, and pregnant and nursing women
US9492421B1 (en) 2013-11-14 2016-11-15 Argent Development Group, Llc Nutritional supplements for treatment of iron deficiency anemia
US9950008B1 (en) * 2014-08-20 2018-04-24 Marc Bellemore Chewable eye health formulation
KR20230146097A (en) 2016-08-12 2023-10-18 엘.이.에이.에프. 홀딩스 그룹 엘엘씨. Alpha and gamma-d polyglutamated antifolates and uses thereof
SE542106C2 (en) 2016-08-26 2020-02-25 Atif M Dabdoub Dietary macro/micronutritional supplement for patients undergoing kidney dialysis
IT201700089258A1 (en) * 2017-08-02 2019-02-02 Pharmanutra S P A Composition for use in the prevention and treatment of iron deficiency
CN107510049B (en) * 2017-09-19 2020-05-08 中南林业科技大学 Solid lipid peach kernel polypeptide ferrous chelate nanoparticle and preparation method thereof
US11083738B2 (en) * 2017-09-28 2021-08-10 Natals, Inc. Dietary nutrient compositions
CN107712909A (en) * 2017-11-13 2018-02-23 济川药业集团有限公司 A kind of iron zinc Muti-vitamine Oral Solution
US11779584B2 (en) 2018-02-07 2023-10-10 L.E.A.F. Holdings Group Llc Alpha polyglutamated pemetrexed and uses thereof
US11730738B2 (en) 2018-02-07 2023-08-22 L.E.A.F. Holdings Group Llc Alpha polyglutamated pralatrexate and uses thereof
CN111971047A (en) * 2018-02-14 2020-11-20 L.E.A.F.控股集团公司 Gamma polyglutamated tetrahydrofolic acid and application thereof
US11771700B2 (en) 2018-02-14 2023-10-03 L.E.A.F. Holdings Group Llc Gamma polyglutamated lometrexol and uses thereof
WO2019165449A1 (en) 2018-02-26 2019-08-29 Allurion Technologies, Inc. Automatic-sealing balloon-filling catheter system
CN114376777B (en) 2018-07-06 2024-02-02 安瑞仁科技公司 Binary fluid control valve system
CN111286519B (en) * 2018-09-25 2021-10-26 杭州园泰生物科技有限公司 Production, extraction and purification process of DHA-rich algae oil
BR112021011198A2 (en) 2018-12-13 2021-08-31 Allurion Technologies, Inc. MEDICAL DEVICE FOR POSITIONING IN A PATIENT, FLUID DISTRIBUTION SYSTEM FOR POSITIONING A MEDICAL DEVICE IN A PATIENT AND DELIVERY A FLUID TO A CLOSED RESERVOIR IN THE DEVICE AND FLUID DISTRIBUTION SYSTEM TO PLACE A MEDICAL DEVICE IN A PATIENT AND DELIVER A FLUID TO A CLOSED RESERVOIR ON THE DEVICE
WO2020128876A1 (en) 2018-12-19 2020-06-25 Presinus Pharmaceuticals Private Limited Composition comprising iodine; selenium, vitamin d3 and lycopene for the prevention and treatment of hypothyroidism
CN109512777A (en) * 2018-12-20 2019-03-26 广州汉光药业股份有限公司 A kind of preparation method improving Vitamin C Stability in compound drops
AR118962A1 (en) * 2019-05-22 2021-11-10 Bayer Consumer Care Ag VITAMIN AND MINERALS SOFT GELATIN CAPSULE PREPARATIONS COMPRISING VITAMIN C IN THE FORM OF AN ASCORBATE SALT
WO2021043883A1 (en) * 2019-09-05 2021-03-11 Société des Produits Nestlé S.A. Food compositions for lactating women
WO2021043882A1 (en) * 2019-09-05 2021-03-11 Société des Produits Nestlé S.A. Food compositions for lactating women
EP4025076A1 (en) * 2019-09-05 2022-07-13 Société des Produits Nestlé S.A. Food compositions for lactating women
WO2021043884A1 (en) * 2019-09-05 2021-03-11 Société des Produits Nestlé S.A. Food compositions for lactating women
IT202000010228A1 (en) * 2020-05-07 2021-11-07 Inpha Res S R L COMPOSITION FOR THE PREVENTION AND TREATMENT OF FOLATE AND/OR VITAMIN B12 DEFICIENCY CONDITIONS, PARTICULARLY HYPERHOMOCYSTEINEMIA
US11147835B1 (en) 2020-08-20 2021-10-19 Frank Kelly Reilly, III Nutritional supplement
WO2022048999A1 (en) * 2020-09-03 2022-03-10 Société des Produits Nestlé S.A. Method for determining dietary food patterns in lactating women
WO2022118274A1 (en) * 2020-12-03 2022-06-09 Neilos S.r.l. Compositions for the use in the treatment and/or prevention of iron deficiency conditions or diseases
CN113274397B (en) * 2021-04-28 2022-06-10 北京诺康达医药科技股份有限公司 Vitamin supplement and preparation method thereof
TW202327559A (en) * 2021-12-09 2023-07-16 瑞士商雀巢製品股份有限公司 Prenatal supplement compositions for increasing breastmilk micronutrient levels

Family Cites Families (391)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB364503A (en) 1931-06-11 1932-01-07 Walther Lange Improvements in or relating to means for exterminating vermin
GB431130A (en) 1933-09-27 1935-07-01 Du Pont Improvements in or relating to the manufacture of salts of hydroxylated amines
GB459657A (en) 1936-04-02 1937-01-13 Royles Ltd Improvements in or relating to filters
GB660611A (en) 1948-12-30 1951-11-07 Procter & Gamble Process for preparing suspensions of solid triglyceride and liquid oil
GB708017A (en) 1951-08-23 1954-04-28 Standard Oil Dev Co Lubricating oil composition
BE543019A (en) 1954-11-24
GB822127A (en) 1957-11-25 1959-10-21 Vitarine Company Inc Stabilized multivitamin compositions containing vitamin b
US3160564A (en) 1961-12-19 1964-12-08 Merck & Co Inc Multi-vitamin composition containing pantothenamide
US3608083A (en) 1968-06-05 1971-09-21 Hoffmann La Roche Vitamin e powder
US6090414A (en) 1970-05-20 2000-07-18 Life Science Labs, Inc. Method and composition to reduce cancer incidence
US3846550A (en) 1971-01-21 1974-11-05 H Akrongold Cosmetic skin powder containing urea
GB1356370A (en) 1972-03-06 1974-06-12 Howard A N Methods and formulations for the treatment of obesity
US4124710A (en) 1975-12-22 1978-11-07 Labaz Acetamidoxime derivatives and use thereof
US4251550A (en) 1979-04-16 1981-02-17 Elaine Powers Nutrition Company, Inc. Meal replacement composition
US4224319A (en) 1979-07-31 1980-09-23 Ernest Marcadet Antiseptic composition for topical application to the skin
FR2490631A1 (en) 1980-09-24 1982-03-26 Roussel Uclaf NOVEL LIPID COMPOSITION FOR USE IN DIETETICS, REANIMATION AND THERAPEUTICS
US4374082A (en) 1981-08-18 1983-02-15 Richard Hochschild Method for making a pharmaceutical and/or nutritional dosage form
ES8301593A1 (en) 1981-11-16 1983-01-01 Union Ind Y Agro Ganader S A U Nucleotide enriched humanized milk and process for its preparation
US4431634A (en) 1981-12-21 1984-02-14 American Cyanamid Company Prenatal iron supplements
GB2113521B (en) 1982-01-25 1985-10-02 Balfour Mfg Protected feedstuffs and their production
DE3368377D1 (en) 1982-04-16 1987-01-29 Nestle Sa Lipid composition for oral, enteral or parenteral feeding
US4619829A (en) 1982-11-16 1986-10-28 Georges Motschan Utilization of a single vitamin or a combination of various vitamins
GB8317248D0 (en) 1983-06-24 1983-07-27 Wyeth John & Brother Ltd Fat compositions
US4547488A (en) 1984-04-16 1985-10-15 Eli Lilly And Company Antibiotic M43D, pharmaceutical compositions and method of use
NL8403433A (en) 1984-11-09 1986-06-02 Holland Melkunie FOOD SUPPLY PREPARATION BASED ON MILK COMPONENTS.
US4863898A (en) 1986-02-06 1989-09-05 Albion International, Inc. Amino acid chelated compositions for delivery to specific biological tissue sites
GB8603171D0 (en) 1986-02-08 1986-03-12 Howard A N Dietary product
US4804535A (en) 1986-05-27 1989-02-14 Rorer Pharmaceutical Corporation Stabilization of multivitamin/trace elements formulations
US4740373A (en) 1986-05-27 1988-04-26 Usv Pharmaceutical Corporation Stabilization of multivitamin/trace elements formulations
US4945083A (en) 1986-06-03 1990-07-31 Jansen Jr Christian J Safe oral folic-acid-containing vitamin preparation
IL80783A0 (en) 1986-10-17 1987-02-27 Univ Bar Ilan Food supplements
US5374560A (en) 1989-04-03 1994-12-20 The University Of Colorado, Inc. Method for screening and distinguishing between cobalamin and folic acid deficiency based on assay for cystathionine and 2-methylcitric acid
US4940658A (en) 1986-11-20 1990-07-10 University Patents, Inc. Assay for sulfhydryl amino acids and methods for detecting and distinguishing cobalamin and folic acid deficency
US5563126A (en) 1986-11-20 1996-10-08 Metabolite Laboratories Method for treatment and prevention of deficiencies of vitamins B12, folic acid, and B6
US5457055A (en) 1986-11-20 1995-10-10 The University Of Colorado Foundation Diagnostic method for cobalamin deficiency
US4851431A (en) 1986-11-26 1989-07-25 Bar Ilan University Physiologically active and nutritional composition
EP0273209B1 (en) 1986-12-30 1992-01-15 American Cyanamid Company Composition of matter containing polycarbophil
US4810726A (en) 1987-04-01 1989-03-07 New England Deaconess Hospital Corporation Kernel oils and disease treatment
DE3711296A1 (en) 1987-04-03 1988-10-13 Basf Ag USE OF ALKOXYLATED CARBOXYL GROUPS OF POLYMERISATS IN DETERGENTS
US4803087A (en) 1987-07-21 1989-02-07 Ppg Industries, Inc. Composition and method for producing vitamin-enriched milk
US6451567B1 (en) 1988-09-07 2002-09-17 Omegatech, Inc. Fermentation process for producing long chain omega-3 fatty acids with euryhaline microorganisms
US5340594A (en) 1988-09-07 1994-08-23 Omegatech Inc. Food product having high concentrations of omega-3 highly unsaturated fatty acids
US6977167B2 (en) 1988-09-07 2005-12-20 Martek Biosciences Corporation Mixtures of omega-3 and omega-6 highly unsaturated fatty acids from euryhaline microorganisms
US5059622A (en) 1989-08-29 1991-10-22 Biosyn, Inc. Method for reducing blood pressure levels in hypertensive persons
ES2081851T3 (en) 1988-10-21 1996-03-16 Nicholas Brown COMPOSITIONS FOR COATINGS AND EMULSIONS.
US5000975A (en) 1988-12-29 1991-03-19 American Home Products Corporation Randomized palm oil fat composition for infant formulas
US5591446A (en) 1989-04-04 1997-01-07 Beiersdorf, A.G. Methods and agents for the prophylaxis of atopy
US5438017A (en) 1989-05-01 1995-08-01 The University Of Colorado Foundation, Inc. Assays for sulfhydryl amino acids and methylmalonic acid and their application to diagnosis of cobalamin deficiency
US5116819A (en) 1989-05-05 1992-05-26 Clintec Nutrition Co. Enteral diet for patients with pulmonary disease
US6451341B1 (en) 1990-02-05 2002-09-17 Thomas J. Slaga Time release formulation of vitamins, minerals and other beneficial supplements
US5407957A (en) 1990-02-13 1995-04-18 Martek Corporation Production of docosahexaenoic acid by dinoflagellates
US5013569A (en) 1990-05-21 1991-05-07 Century Laboratories, Inc. Infant formula
US5132113A (en) 1990-10-26 1992-07-21 Maurizio Luca Nutritional composition containing essential amino acids
ES2033193B1 (en) 1990-10-30 1994-01-16 Ganadera Union Ind Agro FAT MIXTURE FOR CHILD AND ADULT NUTRITION.
US5601860A (en) 1990-11-30 1997-02-11 American Home Products Corporation Corandomized fat compositions for infant formulas
US5658956A (en) 1991-03-01 1997-08-19 Warner-Lambert Company Bioadhesive-wound healing compositions and methods for preparing and using same
US5658957A (en) 1991-03-01 1997-08-19 Warner Lambert Company Immunostimulating wound healing compositions and method for preparing and using same
US5663208A (en) 1991-03-01 1997-09-02 Warner-Lambert Company Antifungal wound healing compositions and methods for preparing and using same
US5641814A (en) 1991-03-01 1997-06-24 Warner-Lambert Company Antikeratolytic-wound healing compositions and methods for preparing and using same
US5648380A (en) 1991-03-01 1997-07-15 Warner-Lambert Company Anti-inflammatory wound healing compositions and methods for preparing and using same
US5460972A (en) 1991-04-08 1995-10-24 Research Foundation Of The State University Of New York Ionized magnesium2+ concentrations in biological samples
US5108767A (en) 1991-06-10 1992-04-28 Abbott Laboratories Liquid nutritional product for persons receiving renal dialysis
US5340315A (en) 1991-06-27 1994-08-23 Abbott Laboratories Method of treating obesity
US5215750A (en) 1991-09-04 1993-06-01 Keane Ii Michael A L-glutamine and vitamin-containing compositions effective for inducing weight loss and for weight control
US5221544A (en) 1991-12-04 1993-06-22 Church & Dwight Co., Inc. Production of dietary fatty acid salt products
US5278329A (en) 1992-02-21 1994-01-11 Zinpro Corporation L-form 1:1 metal methionine complexes
US5221668A (en) 1992-02-26 1993-06-22 Abbott Laboratories Nutritional product for trauma and surgery patients
US5223285A (en) 1992-03-31 1993-06-29 Abbott Laboratories Nutritional product for pulmonary patients
US5210133A (en) 1992-06-15 1993-05-11 Siltech Inc. Silicone polyester polymers as delivery systems
US6410281B1 (en) 1992-07-10 2002-06-25 Omegatech, Inc. Reducing corrosion in a fermentor by providing sodium with a non-chloride sodium salt
CA2144751C (en) 1992-09-23 2001-05-01 George Paradissis Multi-vitamin and mineral supplement for pregnant women
CA2089607C (en) 1992-11-05 1997-11-04 Ranjit K. Chandra Nutritional supplement for the elderly
US5422127A (en) 1992-12-21 1995-06-06 Bristol-Myers Squibb Company Nutritional compositions containing vitamin D esters
AU679020B2 (en) 1992-12-23 1997-06-19 Abbott Laboratories Medical foods for the nutritional support of infant/toddler metabolic diseases
US5326569A (en) 1992-12-23 1994-07-05 Abbott Laboratories Medical foods for the nutritional support of child/adult metabolic diseases
US6207651B1 (en) 1996-08-02 2001-03-27 Metabolite Laboratories Method for treatment and prevention of deficiencies of vitamins B12, folic acid, and B6
US5795873A (en) 1992-12-29 1998-08-18 Metabolite Laboratories, Inc. Method for treatment and prevention of deficiencies of vitamins B12, folic acid and B6
CA2114910C (en) 1993-02-18 2004-08-17 David S. Almond Fatty acid salt pesticidal composition
US5585134A (en) 1993-06-29 1996-12-17 Volac, Inc. Production of rumen-bypass fatty acid salt and protein dietary supplement
US5965162A (en) 1993-09-10 1999-10-12 Fuisz Technologies Ltd. Process for forming chewable quickly dispersing multi-vitamin preparation and product therefrom
US5723446A (en) 1993-12-23 1998-03-03 Nestec Ltd. Enteral formulation designed for optimized nutrient absorption and wound healing
US5714472A (en) 1993-12-23 1998-02-03 Nestec Ltd. Enternal formulation designed for optimized nutrient absorption and wound healing
US6136858A (en) 1994-01-10 2000-10-24 Abbott Laboratories Infant formula and methods of improving infant stool patterns
US5780451A (en) 1994-04-01 1998-07-14 Abbott Laboratories Nutritional product for a person having ulcerative colitis
US5444054A (en) 1994-04-01 1995-08-22 Abbott Labatories Method of treating ulcerative colitis
GB9407386D0 (en) 1994-04-14 1994-06-08 Smithkline Beecham Plc Pharmaceutical formulation
US5574065A (en) 1994-04-21 1996-11-12 Clintec Nutrition Co. Method and composition for normalizing injury response
US6261609B1 (en) 1994-05-24 2001-07-17 Cates, Ii Thomas Gerald Range mineral
US6352713B1 (en) 1999-12-01 2002-03-05 Drugtech Corporation Nutritional composition
US6488956B1 (en) 1994-06-20 2002-12-03 Drugtech Corporation Multi-vitamin and mineral supplements for women
US5869084A (en) 1994-06-20 1999-02-09 K-V Pharmaceuticals Co. Multi-vitamin and mineral supplements for women
DE4424778C1 (en) 1994-07-14 1995-11-16 Grundig Emv Methods of transmission and methods of receiving local radio programs in a single-frequency network and associated transmitters and receivers
US5569458A (en) 1994-09-14 1996-10-29 Greenberg; Mike Nutritional formula
US5660842A (en) 1994-10-04 1997-08-26 Bristol-Myers Squibb Company Inhibition of helicobacter
US5514382A (en) 1994-10-17 1996-05-07 Sultenfuss; Sherry Daily vitamin and mineral supplement for women
US5571441A (en) 1994-11-01 1996-11-05 The Procter & Gamble Company Nutrient supplement compositions providing physiologic feedback
US5545411A (en) 1994-12-16 1996-08-13 Bristol-Myers Squibb Company Method for lowering viscosity by use of gum acacia
US5589468A (en) 1995-01-13 1996-12-31 Clintec Nutrition Co. Method for providing nutrition to elderly patients
US5612060A (en) 1995-05-25 1997-03-18 Alexander; J. Wesley Enhancement of transplant graft survival through nutritional immunomodulation and immunosuppressive therapy
US6099871A (en) 1995-06-01 2000-08-08 Bristol-Myers Squibb Company Anti-regurgitation infant formula
WO1996039053A2 (en) 1995-06-06 1996-12-12 Campbell Soup Company Mineral supplements for dietetic food
CA2222176A1 (en) 1995-06-06 1996-12-12 Campbell Soup Company Compliance support package for increasing health management system compliance
US5626884A (en) 1995-08-18 1997-05-06 Lockett; Curtis G. Treatment of sickle cell disease
US5932624A (en) 1995-10-17 1999-08-03 Herbert; Victor D. Vitamin supplement composition
US5635199A (en) 1995-10-27 1997-06-03 Nestec Ltd. Support of pediatric patients
GB9601398D0 (en) 1996-01-24 1996-03-27 Piper Edwina M Composition
WO1997027764A1 (en) 1996-01-31 1997-08-07 South Alabama Medical Science Foundation Food and vitamin preparations containing the natural isomer of reduced folates
US5948443A (en) 1996-02-23 1999-09-07 Medical Doctor's Research Institute, Inc. Acetylsalicylic acid and micronutrient supplementation for nutritional losses and coronary heart disease
AU2583397A (en) 1996-04-10 1997-10-29 Chronorx, Llc Unit dosage forms, containing magnesium, vitamin c, vitamin e, folate and selenium, for treatment of vasoconstriction and related conditions
US6077828A (en) 1996-04-25 2000-06-20 Abbott Laboratories Method for the prevention and treatment of cachexia and anorexia
WO1998028978A1 (en) 1996-05-08 1998-07-09 Weider Nutrition Group, Inc. Structured glycerols and structured phosphatides
US5874392A (en) 1996-05-09 1999-02-23 Halvorson; Raymond George Soap
US6818228B1 (en) 1996-06-21 2004-11-16 Mission Pharmacal Company Dietary supplements containing ultradense calcium citrate and carbonyl iron
US5914129A (en) 1996-07-23 1999-06-22 Mauskop; Alexander Analgesic composition for treatment of migraine headaches
US20020015742A1 (en) 1998-09-11 2002-02-07 Jackson Sherry D. Method of dietary supplementation
WO1998006277A1 (en) 1996-08-13 1998-02-19 Bristol-Myers Squibb Company Nutritional formulas supplemented with nucleotides, and processes thereof
US6139872A (en) 1996-08-14 2000-10-31 Henkel Corporation Method of producing a vitamin product
US5707670A (en) 1996-08-29 1998-01-13 The Procter & Gamble Company Use of bilayer forming emulsifiers in nutritional compositions comprising divalent mineral salts to minimize off-tastes and interactions with other dietary components
US20040171152A1 (en) 1996-10-10 2004-09-02 Invitrogen Corporation Animal cell culture media comprising non-animal or plant-derived nutrients
AU5264898A (en) 1996-11-20 1998-06-10 Crown Laboratories, Inc. Improved liquid nutritional supplement and aseptic process for making same
US5985339A (en) 1996-11-22 1999-11-16 Kamarei; A. Reza Refrigeration-shelf-stable ready-to-drink complete nutritional compositions and products
US5770215A (en) 1997-01-06 1998-06-23 Moshyedi; Emil Payman Multivitamin/vascular occlusion inhibiting composition
US5866106A (en) 1997-02-03 1999-02-02 Pacer Technology Vitamin/mineral-enriched cyanoacrylate cosmetic
US5976568A (en) 1997-02-21 1999-11-02 Medical Doctors' Research Institute, Inc. Modular system of dietary supplement compositions for optimizing health benefits and methods
EP0986377A1 (en) 1997-03-27 2000-03-22 Bristol-Myers Squibb Company Use of docosahexanoic acid and arachidonic acid enhancing the growth of preterm infants
SA98190002B1 (en) 1997-03-28 2006-06-20 ذي يونيفيرسيتي اوف تننيسي ريسيرش كوربوريشن The use of POLYUNSATURATED FATTY ACIDS to reduce the incidence of necrotizing enterocolitis
US6432684B1 (en) 1997-04-11 2002-08-13 Abbott Laboratories Human desaturase gene and uses thereof
US5922766A (en) 1997-07-02 1999-07-13 Acosta; Phyllis J. B. Palatable elemental medical food
EP0891719A1 (en) 1997-07-14 1999-01-20 N.V. Nutricia Nutritional composition containing methionine
DK0893064T3 (en) 1997-07-22 2003-04-22 Nestle Sa Lipid composition for infant formulas as well as their preparation method
US5877171A (en) 1997-07-28 1999-03-02 Mcleod; Malcolm N. Method of treating pre-menstrual syndrome using chromium
US6054128A (en) 1997-09-29 2000-04-25 Wakat; Diane Dietary supplements for the cardiovascular system
GB9722361D0 (en) 1997-10-24 1997-12-17 Pharma Nord Uk Ltd Pharmaceutical formulation for treating liver disorders
AUPP022297A0 (en) 1997-11-06 1997-11-27 R.P. Scherer Holdings Pty Ltd Vitamin coating
US6093425A (en) 1997-11-21 2000-07-25 Princeton Nutrition, L.L.C. Complete nutritional milk compositions and products
US6013665A (en) 1997-12-16 2000-01-11 Abbott Laboratories Method for enhancing the absorption and transport of lipid soluble compounds using structured glycerides
US5922704A (en) 1997-12-24 1999-07-13 Feeling Fine Company Llc Optimal nutritional supplement for men
US6130244A (en) 1998-02-25 2000-10-10 Abbott Laboratories Product and method to reduce stress induced immune suppression
US6048846A (en) 1998-02-26 2000-04-11 Cochran; Timothy M. Compositions used in human treatment
GB9808579D0 (en) 1998-04-22 1998-06-24 Novartis Nutrition Ag Improvements in or relating to organic compounds
US6197340B1 (en) 1998-05-28 2001-03-06 Medical Research Institute Controlled release lipoic acid
EP1089635A4 (en) 1998-06-23 2002-08-07 Univ Maryland Use of oils having a high lauric acid content as an animal feed
US6245360B1 (en) 1998-06-26 2001-06-12 John S. Markowitz Nutritional supplement
KR100267576B1 (en) 1998-07-25 2000-11-01 허계성 Chewable soft tablet comprising separated active ingredients and process for preparing the same
US6677145B2 (en) 1998-09-02 2004-01-13 Abbott Laboratories Elongase genes and uses thereof
AU1097900A (en) 1998-10-05 2000-04-26 Abbott Laboratories Delta 6 and delta 12 desaturases and modified fatty acid biosynthesis and products produced therefrom
WO2000020603A1 (en) 1998-10-05 2000-04-13 Abbott Laboratories Altered fatty acid biosynthesis in insect cells using delta five desaturase
ES2252989T3 (en) 1998-12-24 2006-05-16 Rad Natural Technologies Ltd. PROCESS FOR THE EXTRACTION OF AN ORGANIC SALT FROM PLANTS, SALT AND OTHER SIMILAR SALTS.
ES2249868T3 (en) 1999-02-12 2006-04-01 Societe Des Produits Nestle S.A. STABILIZED LIQUID COMPOSITION, PREPARATION PROCEDURE AND NUTRITIVE PRODUCT CONTAINING IT.
JP2002537070A (en) 1999-02-26 2002-11-05 ワーナー−ランバート・カンパニー Bioadhesive antimicrobial wound healing composition
US6914073B2 (en) 1999-03-18 2005-07-05 Bristol Myers Squibb Company Vitamin formulation for cardiovascular health
US6383471B1 (en) 1999-04-06 2002-05-07 Lipocine, Inc. Compositions and methods for improved delivery of ionizable hydrophobic therapeutic agents
US6294206B1 (en) 1999-04-09 2001-09-25 Abbott Laboratories Powdered human milk fortifier
MXPA01010778A (en) 1999-04-29 2003-08-20 Nestle Sa Composition for an infant formula having a low threonine content.
US6447809B1 (en) 1999-05-11 2002-09-10 Metagenics, Inc. Composition for promoting healthy bone structure
AU5139600A (en) 1999-05-27 2000-12-18 Drugtech Corporation Nutritional formulations
US6258846B1 (en) 1999-06-01 2001-07-10 Drugtech Corporation Nutritional supplements
US6103756A (en) 1999-08-11 2000-08-15 Vitacost Inc. Ocular orally ingested composition for prevention and treatment of individuals
US6495177B1 (en) 1999-08-13 2002-12-17 Warner Chilcott Laboratories Ireland Limited Orally dissolvable nutritional supplement
EP1211955A1 (en) 1999-08-30 2002-06-12 Ocean Nutrition Canada Ltd. A nutritional supplement for lowering serum triglyceride and cholesterol levels
US6214373B1 (en) 1999-10-07 2001-04-10 Snowden-Sutton Associates, Inc. Nutritional composition for treating inflammatory bowel diseases
AU2058701A (en) 1999-12-02 2001-06-12 F. Hoffmann-La Roche Ag Esters of vitamin D3 and uses thereof
IL150770A0 (en) 2000-01-28 2003-02-12 Omegatech Inc Enhanced production of lipids containing polyenoic fatty acids by high density cultures of eukaryotic microbes in fermentors
WO2001056572A1 (en) 2000-02-02 2001-08-09 Metagenics, Inc. Compositions and methods for promoting healthy joints
US20010028897A1 (en) 2000-02-18 2001-10-11 Milton Hammerly Compositions and treatment methods for benign prostatic hypertrophy
JP4339979B2 (en) 2000-02-28 2009-10-07 雪印乳業株式会社 Folic acid and / or vitamin B12-lactoferrin complex
US20020132035A1 (en) 2001-01-10 2002-09-19 Dov Tamarkin Synthetic fat composition
PT102430B (en) 2000-03-16 2004-05-31 Fortunato Jose Moreira D Costa ADDITIVE METHOD FOR THE PRODUCTION OF POTAVEL WATER AND STANDARDIZED DRINKS FROM WATER (DISTILLED OR DEMINERALIZED) AND BEVERAGES, FOR HEALTH PROFILES
GB0007419D0 (en) 2000-03-27 2000-05-17 Smithkline Beecham Gmbh Composition
GB0009056D0 (en) 2000-04-12 2000-05-31 Nestle Sa Composition comprising free amino acids
US6361800B1 (en) 2000-04-13 2002-03-26 Cooper Concepts, Inc. Multi-vitamin and mineral supplement
US6299896B1 (en) 2000-04-13 2001-10-09 Cooper Concepts, Inc. Multi-vitamin and mineral supplement
ES2752800T3 (en) 2000-05-01 2020-04-06 Cerecin Inc Use of medium chain triglycerides for the treatment and prevention of Parkinson's disease resulting from reduced neuronal metabolism
US20020044969A1 (en) 2000-05-22 2002-04-18 Jerome Harden Method for increasing the compressibility of poorly binding powder materials
US6579544B1 (en) 2000-05-31 2003-06-17 Nutriex, L.L.C. Method for supplementing the diet
WO2002012882A2 (en) 2000-08-08 2002-02-14 Buchanan Baillie Hamilton Paul Slimming system
ATE380541T1 (en) 2000-09-20 2007-12-15 Nycomed Pharma As PRODUCTION OF VITAMIN EMULSIONS AND CONCENTRATES THEREOF
US7696219B2 (en) 2000-09-27 2010-04-13 Everett Laboratories, Inc. Method and composition for supplementation of nutritional deficiences in renal patients
US20020110632A1 (en) 2000-09-29 2002-08-15 The Procter & Gamble Co. Beverage compositions comprising arabinogalactan and defined vitamins
NZ525533A (en) 2000-10-13 2004-09-24 E Z Em Inc A nutritional dietary system, formulation, kit and method for use in preparing an individual for a predetermined activity
DE10057290B4 (en) 2000-11-17 2004-01-08 Fresenius Kabi Deutschland Gmbh Enteral supplement for parenteral nutrition or partial enteral / oral nutrition for critically ill, chronically ill and malnourished
US7105176B2 (en) 2000-11-29 2006-09-12 Basf Aktiengesellschaft Production of solid preparations of water-soluble, sparingly water-soluble or water-insoluble active compounds
US6569445B2 (en) 2000-12-05 2003-05-27 Pbm Pharmaceuticals, Inc. Food bars containing nutritional supplements and anti-constipation and regularity maintaining-agents
US6576253B2 (en) 2000-12-05 2003-06-10 Pbm Pharmaceuticals, Inc. Food bars containing nutritional supplements
US20120237626A9 (en) 2000-12-05 2012-09-20 Palu Afa Kehaati Profiles of lipid proteins and inhibiting HMG-CoA reductase
US6579866B2 (en) 2000-12-28 2003-06-17 Mccleary Larry Composition and method for modulating nutrient partitioning
US6635451B2 (en) 2001-01-25 2003-10-21 Abbott Laboratories Desaturase genes and uses thereof
US20020192310A1 (en) 2001-02-02 2002-12-19 Bland Jeffrey S. Medical composition for managing hormone balance
RU2195269C2 (en) 2001-02-14 2002-12-27 Общество с ограниченной ответственностью "МДТ" Vitamin-mineral complex
US6524610B2 (en) 2001-02-26 2003-02-25 Julia Muszynska Nutritional composition made from conventional foods for mixing onsite in a blender and treating patients with hepatic disorders
NL1017707C2 (en) 2001-03-27 2002-10-01 Jaap Meijer Vitamin preparation.
US7090862B2 (en) 2001-03-30 2006-08-15 Abbott Laboratories Method of improving the antioxidant status of an infant
US6620427B2 (en) 2001-04-24 2003-09-16 Abbott Laboratories Method for improving bone mineralization
US6506413B1 (en) 2001-04-30 2003-01-14 Joseph C. Ramaekers Compositions for treating animal diseases and syndromes
US20030082754A1 (en) 2001-05-04 2003-05-01 Pradip Mukerji Delta4 - desaturase genes and uses thereof
US20030049352A1 (en) 2001-05-31 2003-03-13 Haile Mehansho Fortified drinking water
JP2003012554A (en) 2001-06-26 2003-01-15 Takashi Azumaguchi Composition for alleviating invasion and wound treatment promotion
US6660293B2 (en) 2001-06-29 2003-12-09 Everett Laboratories, Inc. Compositions and methods for prophylactic and therapeutic supplementation of nutrition in subjects
WO2003003981A2 (en) 2001-07-05 2003-01-16 Vital Basics, Inc. Compositions for improving mental performance
US7045150B2 (en) 2001-07-31 2006-05-16 Tellus Biotech Ltd. Tellurium containing nutrient formulation and process for enhancing the cumulative weight gain or feed efficacy in poultry
AU2002323409A1 (en) 2001-08-24 2003-03-10 Martek Biosciences Boulder Corporation Products containing highly unsaturated fatty acids for use by women and their children during stages of preconception, pregnancy and lactation/post-partum
US6849613B2 (en) 2001-08-29 2005-02-01 Kedar N. Prasad Multiple antioxidant micronutrients
US7704542B2 (en) 2001-09-12 2010-04-27 Xanodyne Pharmaceuticals, Inc. Vitamin/mineral compositions with DHA
US20030086981A1 (en) 2001-09-17 2003-05-08 The Nisshin Oil Mills, Ltd. Glycerin fatty acid ester for palliate a symptom of premenstrual syndrome, a palliative of premenstrual syndrome, oil or fat composition for palliate a symptom of premenstrual syndrome, and food and drink for palliate a symptom of premenstrual syndrome
FR2829692B1 (en) 2001-09-17 2004-10-15 Lehning Lab SELECTIVE COMPOSITION OF SIX CATEGORIES OF SUBSTANCES PRESERVING PHYSIOLOGICAL BALANCE IN MAN COMPRISING A MICRONUTRIENT COMPLEX, AN ANTIOXIDANT COMPLEX AND A FATTY ACID COMPLEX.
DE20116346U1 (en) 2001-10-05 2001-12-20 Orthomol Pharmazeutische Vertr Micronutrient combination product, among others with vitamins and carotenoids
EP1302115A1 (en) 2001-10-16 2003-04-16 Societe Des Produits Nestle S.A. Use of cystathionine
WO2003033633A1 (en) 2001-10-18 2003-04-24 Council Of Scientific And Industrial Research Cholesterol lowering structured lipids with omega 3 pufa
JP4276539B2 (en) 2001-10-18 2009-06-10 カウンシル オブ サイエンティフィク アンド インダストリアル リサーチ Cholesterol-lowering structural lipids containing omega-6 PUFA
US20100098779A1 (en) 2008-10-22 2010-04-22 Everett Laboratories, Inc. Compositions and methods for prophylactic and therapeutic supplementation of nutrition in subjects
US7560123B2 (en) 2004-08-12 2009-07-14 Everett Laboratories, Inc. Compositions and methods for nutrition supplementation
US20030099753A1 (en) 2001-11-20 2003-05-29 Yang Baokang Juice based beverage compositions
US6677470B2 (en) 2001-11-20 2004-01-13 Natural Asa Functional acylglycerides
JP2003159028A (en) 2001-11-28 2003-06-03 Hiroshi Suzuki Food for curing pollinosis
ATE450158T1 (en) 2002-01-15 2009-12-15 Karl-Heinz Bauer FOOD SUPPLEMENTS
US6960451B2 (en) 2002-02-06 2005-11-01 Green Earth Industries Proteolytic fermenter
JPWO2003074043A1 (en) 2002-03-04 2005-06-23 日清オイリオグループ株式会社 Body temperature raising agent
US7994217B2 (en) 2002-05-02 2011-08-09 Xanodyne Pharmaceuticals, Inc. Prenatal multivitamin/multimineral supplement
ES2391381T3 (en) 2002-05-03 2012-11-23 Martek Biosciences Corporation High quality lipids and methods for their production by enzymatic release from biomass
US6572903B1 (en) 2002-05-08 2003-06-03 4 Seasons Wildlife Nutrition, Llc Wildlife nutritional supplement
US7014862B2 (en) 2002-05-20 2006-03-21 The Procter & Gamble Company Chewable compositions containing a gel-forming extract of psyllium
DE10223636A1 (en) 2002-05-28 2003-12-11 Gabriele Danners Dietetic food
US7763587B2 (en) 2002-06-13 2010-07-27 L'oreal S.A. Derivative of glucose and of vitamin F, compositions comprising it, uses and preparation process
IL150240A (en) 2002-06-16 2005-07-25 Lipogen Ltd Infant formula supplemented with phospholipids
EP2368445A1 (en) 2002-06-18 2011-09-28 Martek Biosciences Corporation Stable Emulsions of Oils in Aqueous Solutions and Methods for Producing Same
AU2003251557A1 (en) 2002-06-28 2004-01-19 Richard C. Theuer Fat compositions for infant formula and methods therefor
US6565891B1 (en) 2002-08-23 2003-05-20 Tsar Health Private Ltd. Nutritional supplement for children
US20040253227A1 (en) 2002-09-11 2004-12-16 Martin Kenneth A. Perioperative multivitamin protein beverage and additive for use in preparing an individual for fast surgical recovery
CN1310601C (en) 2002-10-10 2007-04-18 惠氏公司 Infant formula containing nucleotides
US7445807B2 (en) 2002-10-15 2008-11-04 Western Holdings, Llc Agglomerated granular protein-rich nutritional supplement
JP2006504752A (en) 2002-10-15 2006-02-09 ロレアル Use of fatty acid amides or esters with sugars in the treatment and / or prevention of dry skin
US20040076664A1 (en) 2002-10-22 2004-04-22 Bonura Michael P. Chewable, soft gel, high potency vitamins and method of manufacture
US20040156882A1 (en) 2002-10-23 2004-08-12 Davenport David F. Method and composition for feeding mammals
US6953588B2 (en) 2002-10-25 2005-10-11 Cooper Concepts, Inc. Multi-vitamin and mineral supplement
FI116627B (en) 2002-11-01 2006-01-13 Danisco A method for regulating the fatty acid chain composition of triglycerides and their use
DE10254584A1 (en) 2002-11-22 2004-06-09 HORST HEIRLER PROJEKTE für Ernährung, Medizin, Ökologie Use of medium chain triglycerides (MCT) for nutritional optimization of the fatty acid spectrum in a dietetic food for diabetics
US8617617B2 (en) 2002-12-10 2013-12-31 Everett Laboratories, Inc. Methods and kits for co-administration of nutritional supplements
US6814983B2 (en) 2002-12-10 2004-11-09 Everett Laboratories, Inc. Compositions and methods for nutrition supplementation
US7261911B2 (en) 2002-12-19 2007-08-28 Luebbers Steven T Aseptically packaged, extensively hydrolyzed, liquid nutritional formula and method for making it
GB2396809A (en) 2003-01-03 2004-07-07 Vitabiotics Ltd Composition for the treatment of HIV and AIDS
KR20050098284A (en) 2003-02-04 2005-10-11 굼링크 에이/에스 Compressed chewing gum tablet
WO2004082398A1 (en) 2003-03-17 2004-09-30 Dsm Ip Assets B.V. Fat soluble vitamin feed supplements and processes for delivering same
US6753350B1 (en) 2003-03-24 2004-06-22 Bristol-Myers Squibb Company Method to reduce the incidence of intraventricular hemorrhage in preterm infants
US7867541B2 (en) 2003-04-14 2011-01-11 Mead Johnson Nutrition Company Compositions and methods of formulation for enteral formulas containing sialic acid
US20040213857A1 (en) * 2003-04-17 2004-10-28 Boehringer Ingelheim International Gmbh Multi-vitamin and mineral supplement for pregnant women
US20040214791A1 (en) 2003-04-25 2004-10-28 Nancy Auestad High lactose infant nutrition formula
US7332178B2 (en) 2003-04-25 2008-02-19 Abbott Laboratories Stable nutritional powder containing ascorbyl palmitate
US20040219188A1 (en) 2003-05-02 2004-11-04 Comer Gail M. Composition and methods for nutritional management of patients with hepatic disease
WO2004098311A1 (en) 2003-05-05 2004-11-18 Denofa As Fish oils with an altered fatty acid profile, method of producing same and their use
US20040234579A1 (en) 2003-05-22 2004-11-25 Mark D. Finke, Inc. Dietary supplements and methods of preparing and administering dietary supplements
CA2432358A1 (en) 2003-06-13 2004-12-13 Medical Futures Inc. Nutritional supplementation for treating deficiency states in bowel disease
US7323200B2 (en) 2003-08-18 2008-01-29 Abbott Laboratories Calcium fortified, soy based, infant nutritional formulas
AU2004266043B2 (en) 2003-08-21 2007-09-20 Duchesnay Inc. Micronutrient supplement
EP1665940A4 (en) 2003-09-02 2011-01-19 Bbk Bio Corp Diet food
US20050064068A1 (en) 2003-09-24 2005-03-24 Shukla Triveni P. Emulsified liquid shortening compositions comprising dietary fiber gel, water and lipid
CA2538680A1 (en) 2003-09-26 2005-04-07 Bristol-Myers Squibb Company Arginyl-glutamine dipeptide for treatment of pathological vascular proliferation
IL158555A0 (en) 2003-10-22 2004-05-12 Enzymotec Ltd Human breast milk lipid mimetic as dietary supplement
RU2543662C2 (en) 2003-10-24 2015-03-10 Н.В. Нютрисиа Synbiotic composition for children for prevention and treatment of diaper skin rash
US20050249823A1 (en) 2003-11-04 2005-11-10 Murphy Tanya K Methods for the prevention or amelioration of neuropsychiatric and related diseases
US9040075B2 (en) 2003-12-19 2015-05-26 Abbott Laboratories Method of increasing lean body mass and reducing body fat mass in infants
US7267830B2 (en) 2003-12-19 2007-09-11 Alcon, Inc. Composition and methods for inhibiting the progression macular degeneration and promoting healthy vision
WO2005067972A1 (en) 2003-12-31 2005-07-28 Integrative Health Consulting, Inc. Nutrient compositions and methods for enhanced effectiveness of the immune system
DK1559430T3 (en) 2004-01-29 2009-07-20 Indena Spa Use of Ginkgo complexes for enhancing cognitive functions and alleviating mental fatigue
US20050181058A1 (en) 2004-02-17 2005-08-18 Andreas Hefel Use of polysaccharides, such as galactomannans, glucomannans and the like for introducing active substances into the human or animal metabolism
US7022350B2 (en) 2004-02-26 2006-04-04 Proethic Pharmaceuticals, Inc. Dietary supplement
US20050226948A1 (en) 2004-03-02 2005-10-13 Lee Steve S Methods for enhancing the transport of glucose into muscle
CA2557927A1 (en) 2004-03-04 2005-09-15 Htl High-Tech Lipids Ltd. Structured triglycerides and emulsions comprising same
US7090879B2 (en) 2004-03-18 2006-08-15 Abbott Laboratories Nutritional formula containing select carotenoid combinations
US20050215640A1 (en) 2004-03-26 2005-09-29 Baxter Jeffrey H HMB compositions and uses thereof
TWI457079B (en) 2004-03-29 2014-10-21 Wyeth Corp Multi-vitamin and mineral nutritional supplements
US20050240434A1 (en) 2004-04-26 2005-10-27 Healthport Corp. System and method of implementing multi-level marketing of weight management products
US8075910B2 (en) 2004-05-20 2011-12-13 Pbm Pharmaceuticals, Inc. Oral compositions comprising edible oils and vitamins and/or minerals and methods for making oral compositions
US8338648B2 (en) 2004-06-12 2012-12-25 Signum Biosciences, Inc. Topical compositions and methods for epithelial-related conditions
US20060024385A1 (en) 2004-07-27 2006-02-02 Pedersen Mark A Metabolic capacity enhancing compositions and methods for use in a mammal
US8101587B2 (en) 2004-08-12 2012-01-24 Everett Laboratories, Inc. Kits for nutrition supplementation
US20060051462A1 (en) 2004-09-03 2006-03-09 Wang Jimmy X Self emulsifying compositions for delivering lipophilic coenzyme Q10 and other dietary ingredients
US20060057186A1 (en) 2004-09-11 2006-03-16 Margaret Heller Oral contraceptive multivitamin compound and methods of administration
WO2006033349A1 (en) 2004-09-22 2006-03-30 Ajinomoto Co., Inc. Total enteral nutritious composition
JP2008514606A (en) 2004-09-24 2008-05-08 リポ ケミカルズ インコーポレイテッド Delivery system for topically applied compounds
US20060078593A1 (en) 2004-09-27 2006-04-13 Strozier Deborah C Nutritional compostions comprising a soluble viscous fiber in a solid crisp matrix
US7186421B2 (en) 2004-09-29 2007-03-06 Proethic Pharmaceuticals, Inc. Mineral additives for improved processing of compositions containing vitamin E and saw palmetto
EP1833313A2 (en) * 2004-10-15 2007-09-19 Corporation Limited Photonz Compositions containing high omega-3 and low saturated fatty acid levels
US20060088574A1 (en) 2004-10-25 2006-04-27 Manning Paul B Nutritional supplements
US20060083824A1 (en) 2004-10-20 2006-04-20 Pbm Products Llc Nutritional supplements for glucose intolerant individuals
US20060115555A1 (en) 2004-12-01 2006-06-01 Foulger Sidney W Nutritional supplements containing xanthone extracts
ITMI20050218A1 (en) 2005-02-15 2006-08-16 Maycos Italiana Di Comini Miro NANOEMULSIONS INCLUDING LIPOAMINO ACIDS MONOGLYCERIDES DIGLYCERIDES POLYGLYCERIDES OF FATTY ACIDS
JP2008532513A (en) 2005-03-08 2008-08-21 フォンテラ コ−オペレイティブ グループ リミティド High-pressure treatment of metal ion lactoferrin
WO2006099237A1 (en) 2005-03-10 2006-09-21 Sciele Pharma, Inc. Nutritional preparations
US20060217385A1 (en) 2005-03-10 2006-09-28 Edwards John B Nutritional preparations
US8968806B2 (en) 2005-04-26 2015-03-03 Sean Joseph Delaney Method and system for creating and using a supplement to balance animal diets
CN101198261B (en) 2005-04-27 2013-05-15 恩兹默泰克有限公司 Human milk fat substitutes
US20060251722A1 (en) 2005-05-03 2006-11-09 Novavax, Inc. Multi-component vitamin and mineral supplement for the optimal absorption of components
FR2885491B1 (en) 2005-05-16 2020-03-06 Nutricos Technologies TREATMENT OF KERATINIC DROUGHT WITH GLYCERIDES
EP1901622B1 (en) 2005-05-23 2014-07-16 Intercontinental Great Brands LLC Taste potentiator compositions and beverages containing same
US20060280840A1 (en) 2005-05-24 2006-12-14 Robertson Marion G Universal protein formulation meeting multiple dietary needs for optimal health and enhancing the human immune system
US7572474B2 (en) 2005-06-01 2009-08-11 Mead Johnson Nutrition Company Method for simulating the functional attributes of human milk oligosaccharides in formula-fed infants
US20070135376A1 (en) 2005-06-20 2007-06-14 Accera, Inc. Method to reduce oxidative damage and improve mitochondrial efficiency
JPWO2007013690A1 (en) 2005-07-28 2009-02-12 味の素株式会社 Method for providing topical coatings and supplements suitable for customers
US20070065556A1 (en) 2005-09-20 2007-03-22 Martin Robert W Jr Nutritional food products employing gelled protein formulations
US7829126B2 (en) 2005-10-26 2010-11-09 Abbott Laboratories Infant formulas containing docosahexaenoic acid and lutein
PT1903866E (en) 2005-11-07 2016-06-09 Murty Pharmaceuticals Inc Improved delivery of tetrahydrocannabinol
US20090137459A1 (en) 2005-11-21 2009-05-28 Katry Inversiones, S.L. Food Product for Enteral or Oral Nutrition
US20070116802A1 (en) 2005-11-23 2007-05-24 Carl Germano High quality caloric composition
WO2007063143A1 (en) 2005-11-30 2007-06-07 Katry Inversiones, S.L. Lipid mixture and use thereof for the preparation of a product that is intended for enteral or oral administration
US20070166411A1 (en) 2005-12-16 2007-07-19 Bristol-Myers Squibb Company Nutritional supplement containing long-chain polyunsaturated fatty acids
MX2008010127A (en) 2006-02-10 2009-03-05 Mannatech Inc All natural multivitamin and multimineral dietary supplement formulations for enhanced absorption and biological utilization.
US8753676B2 (en) 2006-02-15 2014-06-17 Botanocap Ltd. Applications of microencapsulated essential oils
US20070196436A1 (en) 2006-02-23 2007-08-23 Conopco, Inc., D/B/A Unilever Process for preparing an edible composition comprising steroidal glycosides
CN101437410A (en) 2006-03-23 2009-05-20 雀巢产品技术援助有限公司 High-calorie nutritional supplement
US20090306222A1 (en) 2006-04-05 2009-12-10 Chemaphor Inc. Food supplements and uses thereof
US8021659B2 (en) 2006-04-28 2011-09-20 Naidu Lp Coenzyme Q10, lactoferrin and angiogenin compositions and uses thereof
US20080044487A1 (en) 2006-05-05 2008-02-21 Natural Asa Anti-inflammatory properties of marine lipid compositions
US7931930B2 (en) 2006-05-19 2011-04-26 Delavau Llc Delivery of active agents using a chocolate vehicle
US20070292493A1 (en) 2006-06-15 2007-12-20 Brierre Barbara T Pharmaceutical composition and method for the transdermal delivery of calcium
TW200815046A (en) 2006-06-22 2008-04-01 Kaneka Corp Composition containing reduced coenzyme Q10 and production method thereof
US8221809B2 (en) 2006-06-22 2012-07-17 Martek Biosciences Corporation Encapsulated labile compound compositions and methods of making the same
US20080003330A1 (en) 2006-06-30 2008-01-03 Ricardo Rueda Infant formulas for early brain development
US20080014315A1 (en) 2006-07-14 2008-01-17 Delease Patricia Foam-creating compositions, foaming beverage compositions, and methods of preparation thereof
US20080038367A1 (en) 2006-08-11 2008-02-14 Sal Saloum Nutritional supplement compositions and methods of preparing
US20080038410A1 (en) 2006-08-18 2008-02-14 Everett Laboratories, Inc. Compositions and methods for nutrition supplementation
TW200820913A (en) 2006-08-25 2008-05-16 Martek Biosciences Corp Food fortification with polyunsaturated fatty acids
US20080058418A1 (en) 2006-09-06 2008-03-06 The Coca-Cola Company Stable polyunsaturated fatty acid emulsions and methods for inhibiting, suppressing, or reducing degradation of polyunsaturated fatty acids in an emulsion
US9084434B2 (en) 2006-09-27 2015-07-21 Little Calumet Holdings Llc Probiotic oral dosage forms
PL2079321T3 (en) 2006-09-27 2013-11-29 Intercontinental Great Brands Llc Cooling confectioneries and beverages
US20100152107A1 (en) 2006-10-19 2010-06-17 Nestec S.A. Long-term feed - cancer patient
JP2010513226A (en) 2006-10-19 2010-04-30 ネステク ソシエテ アノニム Long-term nutrition supply for the elderly
CN101522220B (en) 2006-10-19 2012-05-16 雀巢产品技术援助有限公司 Long-term enteral feed for maintenance
US20080102137A1 (en) 2006-10-31 2008-05-01 Guffey Manning V R Composition and method for etiological treatment and prevention of diseases and/or complications associated with chronic glucose metabolism destabilization
KR20090106493A (en) 2006-12-01 2009-10-09 안테리오스, 인코퍼레이티드 Micellar nanoparticles comprising botulinum toxin
US20080233245A1 (en) 2007-03-19 2008-09-25 Lesley Joan White Liquid nutrient composition for improving performance
US20100113294A1 (en) 2007-04-16 2010-05-06 Momenta Pharmaceuticals, Inc. Defined glycoprotein products and related methods
EP1982604A1 (en) 2007-04-20 2008-10-22 Naturheilzentrum Allgäu Dietary supplement for compensating for a lack of nutrients
BRPI0810127A2 (en) 2007-04-24 2014-09-23 Lipid Nutrition Bv Yogurt, Process for Producing Yogurt, and Using a Yogurt
EP2152100B1 (en) 2007-04-24 2017-12-13 Stepan Specialty Products, LLC Beverage composition comprising cla
RU2009143325A (en) 2007-04-24 2011-05-27 Липид Нутришн Б.В. (Nl) BEVERAGE COMPOSITION
JP2010524493A (en) 2007-04-29 2010-07-22 シェメン インダストリーズ リミテッド Oil composition for nutrition supply for infants and toddlers
WO2008153748A1 (en) 2007-05-24 2008-12-18 The Mclean Hospital Corporation Methods and compositions for the use of sargassum fusiforme for the inhibition of hiv-1 infection
WO2008147228A1 (en) 2007-05-31 2008-12-04 Fonterra Corporate Research And Development Limited Treatment or prevention of bone conditions
WO2008148552A2 (en) 2007-06-05 2008-12-11 Lonza Inc Methods and compositions relating to administration of l-carnitine
EP2162153B1 (en) 2007-06-06 2016-03-30 Novus International Inc. Dietary supplements for promotion of growth, repair, and maintenance of bone and joints
US20080305096A1 (en) 2007-06-07 2008-12-11 Unicity International, Inc. Method and composition for providing controlled delivery of biologically active substances
US20080317725A1 (en) 2007-06-20 2008-12-25 Baum Seth J Compositions and methods of treating chronic kidney disease
US20090004281A1 (en) 2007-06-26 2009-01-01 Biovail Laboratories International S.R.L. Multiparticulate osmotic delivery system
SI2178386T1 (en) 2007-07-02 2011-01-31 Sime Darby Malaysia Berhad Frying fat composition
CN101790305A (en) 2007-07-03 2010-07-28 诺华丝国际股份有限公司 But the pig starter feed dispensing that the fermentable carbohydrates level is low
US8828960B2 (en) 2007-07-17 2014-09-09 Idexx Laboratories, Inc. Amino acid vitamin ester compositions for controlled delivery of pharmaceutically active compounds
SG174110A1 (en) 2007-07-30 2011-10-28 Phyto Pharma Pte Ltd New ganoderma tsugae var. jannieae strain tay-i and biologically active biomass and extracts therefrom
CN101095433B (en) 2007-08-03 2010-06-02 内蒙古蒙牛乳业(集团)股份有限公司 Liquid milk suitable for 1 to 3 years old children and the method for producing the same
MX2010001260A (en) 2007-08-03 2010-04-07 Shaklee Corp Nutritional supplement system.
WO2009020902A1 (en) 2007-08-07 2009-02-12 Dr Pepper Snapple Group Buffered tea-milk compositions and associated beverages and methods
US20090068190A1 (en) 2007-08-29 2009-03-12 Drugtech Corporation Anti-proliferative combinations
US8911798B2 (en) 2007-09-17 2014-12-16 Ajay Gupta Multivitamin and mineral compositions for individuals having renal disease
EP2052727A3 (en) 2007-10-02 2010-06-02 Unilever N.V. Hoodia extract oil compositions comprising unsaturated monoacylglycerides
NO2194781T3 (en) 2007-10-04 2018-07-21
FR2921828B1 (en) 2007-10-04 2012-06-29 Oreal COSMETIC OR PHARMACEUTICAL COMPOSITION COMPRISING A POLYCONDENSATE, SAID POLYCONDENSATE, AND COSMETIC TREATMENT METHOD.
WO2009066299A2 (en) * 2007-11-23 2009-05-28 Rappaport Family Institute For Research Use of haptoglobin genotyping in diagnosis and treatment of cardiovascular disease
EP2229163A1 (en) 2007-12-04 2010-09-22 Westgate Biological Limited Antimicrobial compositions comprising fatty acids and milk proteins
RU2010129825A (en) 2007-12-17 2012-01-27 Юриверсити Оф Флорида Рисерч Фаундейшн, Инк. (Us) MATERIALS AND METHODS FOR TREATMENT OF PATHOLOGICAL PROLIFERATION OF EYE VESSELS
DK2229156T3 (en) 2007-12-20 2017-02-06 Fertin Pharma As CHEW GUM TABLE AND PROCEDURE FOR DOSING PHARMACEUTICAL ACTIVE INGREDIENTS IN SUCH CHEW GUM TABLE
WO2009080021A1 (en) 2007-12-20 2009-07-02 Fertin Pharma A/S Compressed chewing gum tablet
US8440181B2 (en) 2008-02-07 2013-05-14 Ralph Brown Prevention of micronutrient deficiencies associated with common disabilities in the over 50 adult
GB2458466A (en) 2008-03-18 2009-09-23 Kartar Singh Lalvani Composition for hair, skin and nail health maintenance
DK2282645T3 (en) 2008-05-26 2015-07-13 Fertin Pharma As Flavor impregnation of a chewing gum
US20090311367A1 (en) 2008-06-17 2009-12-17 Perry Stephen C Dietary Supplement
EP2143340A1 (en) 2008-07-07 2010-01-13 Nestec S.A. A nutritional composition with free amino acids and structured lipids
CN101322554B (en) 2008-07-18 2012-07-04 哈尔滨医科大学 Health products for reducing fat
US20100021573A1 (en) 2008-07-22 2010-01-28 Michael J Gonzalez Compositions and methods for the prevention of cardiovascular disease
BRPI0917949A2 (en) 2008-08-11 2015-08-18 Abunda Nutrition Inc Oil fat, fat or oil composition, food composition, and method for providing one or more health benefits
WO2010018418A1 (en) 2008-08-12 2010-02-18 Novatech D.O.O. Formulation based on micronized clinoptilolite as therapeutic agent providing highly bioavailable silicon
US20100041622A1 (en) 2008-08-13 2010-02-18 Bromley Philip J Compositions containing aminoalkanes and aminoalkane derivatives
US20100055187A1 (en) 2008-08-28 2010-03-04 Dong June Ahn Nanovitamin synthesis
WO2010030600A2 (en) 2008-09-10 2010-03-18 Code Nutrition, Llc Methods and compositions for personalization of dietary supplements based on genetic markers
CN101675805B (en) 2008-09-16 2013-12-11 孙志刚 Combined capsule for middle-aged and elderly people
CN101675806B (en) 2008-09-16 2013-12-11 孙志刚 Combined capsule for adults
CN101675804B (en) 2008-09-16 2013-12-11 孙志刚 Juvenile ABC ODAC composite capsule best nutritional supplement
US20100124587A1 (en) 2008-11-17 2010-05-20 Heuer Marvin A Creatine-containing vitamin and mineral composition
DE102008057867A1 (en) 2008-11-18 2010-05-20 B. Braun Melsungen Ag Fat emulsion for the artificial nutrition of severely ill intensive care patients
US20100136168A1 (en) 2008-12-03 2010-06-03 Mchaney Blair C Supplemented fruit or vegetable product
US20100159029A1 (en) 2008-12-23 2010-06-24 Alcon Research, Ltd. Composition and nutritional supplements for improving ocular health and reducing ocular inflammatory response
EP2215913A1 (en) 2009-01-23 2010-08-11 Nutreco Nederland B.V. Animal feed additive and animal feed comprising alkyl esters of medium chain fatty acids, and their use in animal feed
US8241672B2 (en) 2009-03-11 2012-08-14 Stable Solutions Llc Omega-3 enriched fish oil-in-water parenteral nutrition emulsions
CN102413813B (en) 2009-03-24 2014-11-12 Adds制药有限责任公司 Stabilized solubility-enhanced formulations for oral delivery
US20100316735A1 (en) 2009-04-10 2010-12-16 Wade Belliston Compositions and methods for reducing hangover symptoms
IT1393710B1 (en) 2009-04-29 2012-05-08 Graal Srl OROBUCCAL COMPOSITIONS CONTAINING A MIXTURE OF LUTEIN AND ZEAXANTHIN.
US8197871B2 (en) 2009-05-13 2012-06-12 L Europa Gary A Composition for headache treatment
CN102573496B (en) 2009-07-01 2015-08-26 玛格塞蒂克斯公司 Slow release magnesium composition and uses thereof
FR2948025B1 (en) 2009-07-15 2013-01-11 Univ Grenoble 1 COMPOSITION COMPRISING POLYPHENOL AND OMEGA-3 FATTY ACID
US20110045050A1 (en) 2009-08-24 2011-02-24 Atrium Medical Corporation Nanoemulsion formulations for direct delivery
IN2012DN02245A (en) 2009-09-14 2015-05-22 Nestec Sa
TW201112967A (en) 2009-09-16 2011-04-16 Abbott Lab Dryblended nutritional powders
US9186642B2 (en) 2010-04-28 2015-11-17 The Procter & Gamble Company Delivery particle

Cited By (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103211216A (en) * 2013-04-25 2013-07-24 福建永生活力生物工程有限公司 Health food with function of improving memory in aided manner and preparation method thereof
US9993457B2 (en) 2014-11-25 2018-06-12 Abbott Laboratories Method of improving visual processing, visual acuity, or both by administering compositions comprising RRR-alpha-tocopherol and carotenoid to infants
US10245250B2 (en) 2014-11-25 2019-04-02 Abbott Laboratories Method of improving visual processing, visual acuity, or both by administering compositions comprising RRR-alpha-tocopherol to infants
US10668088B2 (en) 2015-01-15 2020-06-02 Dsm Ip Assets B.V. Combination of 25-hydroxyvitamin D and antioxidants/anti-inflammatories for human nutraceuticals
WO2016113387A1 (en) * 2015-01-15 2016-07-21 Dsm Ip Assets B.V. Combination of 25-hydroxyvitamin d and antioxidants/anti-inflammatories for human nutraceuticals
CN107105744A (en) * 2015-01-15 2017-08-29 帝斯曼知识产权资产管理有限公司 Combination for 25 hydroxy-vitamine Ds and antioxidant/antiinflammatory of people's nutriment
JP2018503605A (en) * 2015-01-15 2018-02-08 ディーエスエム アイピー アセッツ ビー.ブイ. 25-Hydroxyvitamin D and antioxidant / anti-inflammatory combination for human functional foods
US11040045B2 (en) 2015-01-15 2021-06-22 Dsm Ip Assets B.V. Combination of 25-hydroxyvitamin D and antioxidants/anti-inflammatories for human nutraceuticals
US10863756B2 (en) 2015-01-15 2020-12-15 Dsm Ip Assets B.V. Method of preventing obesity and cardiovascular problems in poultry
US10517316B2 (en) 2015-01-15 2019-12-31 Dsm Ip Assets B.V. Combination of 25-hydroxyvitamin D and antioxidants/anti-inflammatories for bovine health
WO2018102426A1 (en) * 2016-11-29 2018-06-07 University Of Iowa Research Foundation Use of nad precursors for improving maternal health and/or offspring health
CN110234238A (en) * 2016-11-29 2019-09-13 爱荷华大学研究基金会 NAD precursor is used to improve the purposes of parent health and/or offspring's health
US11071747B2 (en) 2016-11-29 2021-07-27 University Of Iowa Research Foundation Use of NAD precursors for breast enhancement
US11633421B2 (en) 2016-11-29 2023-04-25 University Of Iowa Research Foundation Use of NAD precursors for improving maternal health and/or offspring health
US20190008755A1 (en) * 2017-07-07 2019-01-10 H & H Science, Llc Clear skin vitamin
WO2020118089A1 (en) * 2018-12-08 2020-06-11 Aphios Corportion Methods and products for treating folic acid deficiency and morning sickness
JP2022512331A (en) * 2018-12-08 2022-02-03 アフィオス コーポレーション Methods and products for treating folic acid deficiency and morning sickness
WO2021108527A1 (en) * 2019-11-25 2021-06-03 Lian xu li Dietary supplement

Also Published As

Publication number Publication date
US20220079201A1 (en) 2022-03-17
US20220279831A1 (en) 2022-09-08
US8183227B1 (en) 2012-05-22
US20170112178A1 (en) 2017-04-27

Similar Documents

Publication Publication Date Title
US20220279831A1 (en) Compositions, kits and methods for nutrition supplementation
US8545896B2 (en) Compositions, kits and methods for nutrition supplementation
US10265343B2 (en) Kits and methods for nutrition supplementation
US8617617B2 (en) Methods and kits for co-administration of nutritional supplements
US10201560B2 (en) Compositions and methods for nutrition supplementation
US20170202802A1 (en) Compositions, kits and methods for nutrition supplementation
US20130084272A1 (en) Compositions, kits and methods for nutritional supplementation with twelve carbon chain fatty acids and twelve carbon chain acylglycerols
US9398776B2 (en) Nutritional supplements for 50+ individuals for improving vitality, immunity, eye and bone health
US20190021385A1 (en) Orally dissolvable compositions for nutrition supplementation
US20240082197A1 (en) Delivery methods for omega-3&#39;s and compositions for vitamins and minerals used to enhance visual acuity and mental development in the human body
US20150305386A1 (en) Compositions for nutritional supplementation
WO2015167434A1 (en) Compositions for nutritional supplementation

Legal Events

Date Code Title Description
AS Assignment

Owner name: CHEMO S.A. FRANCE, FRANCE

Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:PERRIN, PHILIPPE;HERRY, GUILLAUME;SIGNING DATES FROM 20111230 TO 20121215;REEL/FRAME:037225/0811

STCB Information on status: application discontinuation

Free format text: ABANDONED -- FAILURE TO RESPOND TO AN OFFICE ACTION