Compositions, kits and methods for nutrition supplementation

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.

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.