Methods and kits for co-administration of nutritional supplements

Abstract

The present invention relates to methods of co-administration of various vitamin and mineral compositions, and in a specific embodiment, said methods comprise co-administering one composition comprising vitamin A, vitamin D, vitamin C, vitamin E, folic acid, vitamin B 1 , vitamin B 2 , vitamin B 6 , vitamin B 12 , niacin, calcium, iron, magnesium, zinc, and/or copper, and a second composition comprising omega-3 fatty acids such as DHA, to supplement the nutritional needs of individuals within physiologically stressful states; and kits provided for co-administration of various vitamin and mineral compositions, and in a specific embodiment, said kits comprise one composition comprising vitamin A, vitamin D, vitamin C, vitamin E, folic acid, vitamin B 1 , vitamin B 2 , vitamin B 6 , vitamin B 12 , niacin, calcium, iron, magnesium, zinc, and/or copper, and a second composition comprising omega-3 fatty acids such as DHA, to supplement the nutritional needs of individuals within physiologically stressful states.

What is claimed is: 
     
         1 . A method comprising co-administering a first composition comprising vitamin A, vitamin D, vitamin C, vitamin E, folic acid, vitamin B 1 , vitamin B 2 , vitamin B 6 , vitamin B 12 , niacin, calcium, iron, magnesium, zinc, and copper to a patient and a second composition comprising omega-3 fatty acids to said patient. 
     
     
         2 . The method of  claim 1 , wherein said omega-3 fatty acids comprise docosahexaenoic acid (DHA). 
     
     
         3 . The method of  claim 1 , wherein said first composition and said second composition are co-administered at the same time. 
     
     
         4 . The method of  claim 1 , wherein said first composition and said second composition are co-administered to said patient, one said composition before the other said composition, in either order. 
     
     
         5 . The method of  claim 1 , wherein said first composition is administered to said patient orally and said second composition is administered to said patient orally. 
     
     
         6 . The method of  claim 1 , wherein one or both of said first and said second composition is in a swallowable form. 
     
     
         7 . The method of  claim 1 , wherein one or both of said first and said second composition is in a chewable form. 
     
     
         8 . The method of  claim 1 , wherein one or both of said first and said second composition is in a dissolvable form. 
     
     
         9 . The method of  claim 1 , wherein said vitamin A comprises acetate. 
     
     
         10 . The method of  claim 1 , wherein said vitamin B 1  comprises thiamine mononitrate. 
     
     
         11 . The method of  claim 1 , wherein said vitamin B 6  comprises pyridoxine hydrochloride. 
     
     
         12 . The method of  claim 1 , wherein said folic acid comprises one or more of the group consisting of vitamin B 9 , folacin, metafolin, and folate. 
     
     
         13 . The method of  claim 1 , wherein said folic acid comprises one or more natural derivatives of folate selected from the group consisting of (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. 
     
     
         14 . The method of  claim 1 , wherein said vitamin B 12  comprises cyanocobalamin. 
     
     
         15 . The method of  claim 1 , wherein said vitamin C comprises ascorbic acid. 
     
     
         16 . The method of  claim 1 , wherein said vitamin E comprises d-alpha tocopheryl acetate. 
     
     
         17 . The method of  claim 1 , wherein said vitamin E comprises d-alpha tocopheryl succinate. 
     
     
         18 . The method of  claim 1 , wherein said iron comprises ferrous fumarate. 
     
     
         19 . The method of  claim 1 , wherein said magnesium comprises magnesium oxide. 
     
     
         20 . The method of  claim 1 , wherein said zinc comprises zinc oxide. 
     
     
         21 . The method of  claim 1 , wherein said first composition is substantially free of one or more of added compounds selected from the group consisting of vitamin A, vitamin D, vitamin C, vitamin E, folic acid, vitamin B 1 , vitamin B 2 , vitamin B 6 , vitamin B 12 , niacin, calcium, iron, magnesium, zinc, and copper. 
     
     
         22 . The method of  claim 1 , wherein said first and said second compositions are substantially free of one or more of added active compounds selected from the group consisting of lutein, lycopene, zeaxanthin, vitamin B 4 , vitamin B 5 , vitamin B 7 , vitamin B 8 , vitamin B 10 , vitamin K, biotin, pantothenic acid, phosphorus, iodine, potassium, odorless garlic, coenzyme Q 10 , 1-carnitine, grape seed extract, chloride, sodium, green tea extract, quercetin, fluoride, hawthorne berries, and alpha lipoic acid. 
     
     
         23 . The method of  claim 1 , wherein said first and said second compositions are substantially free of one or more of added minerals and compounds selected from the group consisting of chromium, titanium, molybdenum, nickel, tin, silicon, vanadium, manganese, selenium, selenite, boron, bismuth, borax, bauxite, gold, silver, hydroxylapatite, mica, quartz, steatite, talc, sulfur, and zircon. 
     
     
         24 . The method of  claim 1 , wherein said first and said second compositions are substantially free of one or more of added inactive compounds selected from the group consisting of magnesium stearate, silica, silicon dioxide, magnesium silicate, dicalcium phosphate, povidone, titanium dioxide, sodium benzoate, alpha lipoic acid, lutein, lycopene, cellulose, croscarmellose sodium, stearic acid, cellulose, hydroxylpropyl cellulose, hydroxypropyl methylcellulose, titanium dioxide, polydextrose, triacetin, dicalcium phosphate, polyethylene glycol, polyvinylpyrrolidone, mineral oil, methocel, sodium lauryl sulfate, and talc. 
     
     
         25 . The method of  claim 1 , wherein said first composition further comprises a pharmaceutically acceptable carrier and said second composition further comprises a pharmaceutically acceptable carrier. 
     
     
         26 . The method of  claim 25 , wherein said pharmaceutically acceptable carrier is one or more selected from the group consisting of binders, diluents, lubricants, glidants, colorants, emulsifiers, disintegrants, starches, water, oils, alcohols, preservatives and sugars. 
     
     
         27 . The method of  claim 1 , wherein said first composition further comprises a sweetening agent and said second composition further comprises a sweetening agent. 
     
     
         28 . The method of  claim 1 , wherein said first composition further comprises a flavorant and said second composition further comprises a flavorant. 
     
     
         29 . The method of  claim 1 , wherein said first composition further comprises alkyl polysiloxane in an amount of about 0.05 weight percent to less than about 1.0 weight percent of the said composition one, and said second composition further comprises alkyl polysiloxane in an amount of about 0.05 weight percent to less than about 1.0 weight percent of said second composition. 
     
     
         30 . The method of  claim 29 , wherein said alkyl polysiloxane is in the form of dimethyl polysiloxane. 
     
     
         31 . The method of  claim 1 , wherein said vitamin A is present in the range of about 1350 IU to about 4050 IU. 
     
     
         32 . The method of  claim 1 , wherein said vitamin D is present in the range of about 200 IU to about 600 IU. 
     
     
         33 . The method of  claim 1 , wherein said vitamin C is present in the range of about 35 mg to about 105 mg. 
     
     
         34 . The method of  claim 1 , wherein said vitamin E is present in the range of about 15 IU to about 45 IU. 
     
     
         35 . The method of  claim 1 , wherein said folic acid is present in the range of about 0.5 mg to about 1.5 mg. 
     
     
         36 . The method of  claim 1 , wherein said vitamin B 1  is present in the range of about 0.8 mg to about 2.4 mg. 
     
     
         37 . The method of  claim 1 , wherein said vitamin B 2  is present in the range of about 0.9 mg to about 2.7 mg. 
     
     
         38 . The method of  claim 1 , wherein said vitamin B 6  is present in the range of about 1.25 mg to about 3.75 mg. 
     
     
         39 . The method of  claim 1 , wherein said B 12  is present in the range of about 6 mcg to about 18 mcg. 
     
     
         40 . The method of  claim 1 , wherein said niacin is present in the range of about 9 mg to about 27 mg. 
     
     
         41 . The method of  claim 1 , wherein said calcium is present in the range of about 50 mg to about 150 mg. 
     
     
         42 . The method of  claim 1 , wherein said iron is present in the range of about 32.5 mg to about 97.5 mg. 
     
     
         43 . The method of  claim 1 , wherein said magnesium is present in the range of about 12.5 mg to about 37.5 mg. 
     
     
         44 . The method of  claim 1 , wherein said zinc is present in the range of about 12.5 mg to about 37.5 mg. 
     
     
         45 . The method of  claim 1 , wherein said copper is present in the range of about 1 mg to about 3 mg. 
     
     
         46 . The method of  claim 1 , wherein said first composition comprises about 1350 IU to about 4050 IU of vitamin A; about 200 IU to about 600 IU of vitamin D; about 35 mg to about 105 mg of vitamin C; about 15 IU to about 45 IU of vitamin E; about 0.5 mg to about 1.5 mg of folic acid; about 0.8 mg to about 2.4 mg of vitamin B1; about 0.9 mg to about 2.7 mg of vitamin B2; about 1.25 mg to about 3.75 mg of vitamin B6; about 6 mcg to about 18 mcg of vitamin B12; about 9 mg to about 27 mg of niacin; about 50 mg to about 150 mg of calcium; about 32.5 mg to about 97.5 mg of iron; about 12.5 mg to about 37.5 mg of magnesium; about 12.5 mg to about 37.5 mg of zinc; and about 1 mg to about 3 mg of copper. 
     
     
         47 . The method of  claim 1 , wherein said first composition comprises about 2700 IU vitamin A; about 400 IU vitamin D; about 70 mg vitamin C; about 30 IU vitamin E; about 1.0 mg folic acid; about 1.6 mg vitamin B 1 ; about 1.8 mg vitamin B 2 ; about 2.5 mg vitamin B 6 ; about 12 mcg vitamin B 12 ; about 18 mg niacin; about 100 mg calcium; about 65 mg iron; about 25 mg magnesium; about 25 mg zinc; and about 2 mg copper. 
     
     
         48 . The method of  claim 1 , wherein said patient is pregnant. 
     
     
         49 . The method of  claim 1 , wherein said patient is lactating. 
     
     
         50 . The method of  claim 1 , wherein said patient has nutritional deficiencies. 
     
     
         51 . The method of  claim 50 , wherein said nutritional deficiencies are a result of pregnancy. 
     
     
         52 . The method of  claim 50 , wherein said nutritional deficiencies are a result of lactation. 
     
     
         53 . The method of  claim 50 , wherein said nutritional deficiencies are a result of elevated metabolic demand. 
     
     
         54 . The method of  claim 50 , wherein said nutritional deficiencies are a result of increased plasma volume. 
     
     
         55 . The method of  claim 1 , wherein said patient is within a physiologically stressful state. 
     
     
         56 . The method of  claim 55 , wherein said physiologically stressful state is any disease state. 
     
     
         57 . The method of  claim 1 , wherein said omega-3 fatty acids are enclosed within a gel-cap. 
     
     
         58 . The method of  claim 1 , wherein said second composition is in liquid form. 
     
     
         59 . The method of  claim 1 , wherein said omega-3 fatty acids are present in the amount of about 50 mg to about 150 mg. 
     
     
         60 . The method of  claim 1 , wherein said omega-3 fatty acids are present in the amount of about 75 mg to about 125 mg. 
     
     
         61 . The method of  claim 1 , wherein said omega-3 fatty acids are present in the amount of about 90 mg to about 110 mg. 
     
     
         62 . The method of  claim 1 , wherein said omega-3 fatty acids are present in the amount of about 100 mg. 
     
     
         63 . A kit comprising: a first composition comprising vitamin A, vitamin D, vitamin C, vitamin E, folic acid, vitamin B 1 , vitamin B 2 , vitamin B 6 , vitamin B 12 , niacin, calcium, iron, magnesium, zinc, and/or copper; and a second composition comprising omega-3 fatty acids; wherein said first and second compositions are packaged for co-administration to a patient, in any order. 
     
     
         64 . The kit of  claim 63 , wherein said omega-3 fatty acids comprise docosahexaenoic acid (DHA). 
     
     
         65 . The kit of  claim 63 , wherein said first composition and said second composition are co-administered at the same time. 
     
     
         66 . The kit of  claim 63 , wherein said first composition and said second composition are co-administered to said patient, one said composition before the other said composition, in either order. 
     
     
         67 . The kit of  claim 63 , wherein said first composition is administered to said patient orally and said second composition is administered to said patient orally. 
     
     
         68 . The kit of  claim 63 , wherein one or both of said first and said second composition is in a swallowable form. 
     
     
         69 . The kit of  claim 63 , wherein one or both of said first and said second composition is in a chewable form. 
     
     
         70 . The kit of  claim 63 , wherein one or both of said first and said second composition is in a dissolvable form. 
     
     
         71 . The kit of  claim 63 , wherein said vitamin A comprises acetate. 
     
     
         72 . The kit of  claim 63 , wherein said vitamin B 1  comprises thiamine mononitrate. 
     
     
         73 . The kit of  claim 63 , wherein said vitamin B 6  comprises pyridoxine hydrochloride. 
     
     
         74 . The kit of  claim 63 , wherein said folic acid comprises one or more of the group consisting of vitamin B 9 , folacin, metafolin, and folate. 
     
     
         75 . The kit of  claim 63 , wherein said folic acid comprises one or more natural derivatives of folate selected from the group consisting of (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. 
     
     
         76 . The kit of  claim 63 , wherein said vitamin B 12  comprises cyanocobalamin. 
     
     
         77 . The kit of  claim 63 , wherein said vitamin C comprises ascorbic acid. 
     
     
         78 . The kit of  claim 63 , wherein said vitamin E comprises d-alpha tocopheryl acetate. 
     
     
         79 . The kit of  claim 63 , wherein said vitamin E comprises d-alpha tocopheryl succinate. 
     
     
         80 . The kit of  claim 63 , wherein said iron comprises ferrous fumarate. 
     
     
         81 . The kit of  claim 63 , wherein said magnesium comprises magnesium oxide. 
     
     
         82 . The kit of  claim 63 , wherein said zinc comprises zinc oxide. 
     
     
         83 . The kit of  claim 63 , wherein said first composition is substantially free of one or more of added compounds selected from the group consisting of vitamin A, vitamin D, vitamin C, vitamin E, folic acid, vitamin B 1 , vitamin B 2 , vitamin B 6 , vitamin B 12 , niacin, calcium, iron, magnesium, zinc, and copper. 
     
     
         84 . The kit of  claim 63 , wherein said first and said second compositions are substantially free of one or more of added active compounds selected from the group consisting of lutein, lycopene, zeaxanthin, vitamin B 4 , vitamin B 5 , vitamin B 7 , vitamin B 8 , vitamin B 10 , vitamin K, biotin, pantothenic acid, phosphorus, iodine, potassium, odorless garlic, coenzyme Q 10 , 1-carnitine, grape seed extract, chloride, sodium, green tea extract, quercetin, fluoride, hawthorne berries, and alpha lipoic acid. 
     
     
         85 . The kit of  claim 63 , wherein said first and said second compositions are substantially free of one or more of added minerals and compounds selected from the group consisting of chromium, titanium, molybdenum, nickel, tin, silicon, vanadium, manganese, selenium, selenite, boron, bismuth, borax, bauxite, gold, silver, hydroxylapatite, mica, quartz, steatite, talc, sulfur, and zircon. 
     
     
         86 . The kit of  claim 63 , wherein said first and said second compositions are substantially free of one or more of added inactive compounds selected from the group consisting of magnesium stearate, silica, silicon dioxide, magnesium silicate, dicalcium phosphate, povidone, titanium dioxide, sodium benzoate, alpha lipoic acid, lutein, lycopene, cellulose, croscarmellose sodium, stearic acid, cellulose, hydroxylpropyl cellulose, hydroxypropyl methylcellulose, titanium dioxide, polydextrose, triacetin, dicalcium phosphate, polyethylene glycol, polyvinylpyrrolidone, mineral oil, methocel, sodium lauryl sulfate, and talc. 
     
     
         87 . The kit of  claim 63 , wherein said patient is pregnant. 
     
     
         88 . The kit of  claim 63 , wherein said patient is lactating. 
     
     
         89 . The kit of  claim 63 , wherein said omega-3 fatty acids are enclosed within a gel-cap. 
     
     
         90 . The kit of  claim 63 , wherein said second composition is in liquid form. 
     
     
         91 . The kit of  claim 63 , wherein said omega-3 fatty acids are present in the amount of about 50 mg to about 150 mg. 
     
     
         92 . The kit of  claim 63 , wherein said omega-3 fatty acids are present in the amount of about 100 mg. 
     
     
         93 . The kit of  claim 63 , wherein said packaging is selected from the group consisting of bottles and blister packs. 
     
     
         94 . The kit of  claim 93 , wherein said blister packs are sold together and said blister packs comprise a first blister pack containing said first composition and a second blister pack containing said second composition. 
     
     
         95 . The kit of  claim 93 , wherein said blister pack contains both said first composition and said second composition paired together per unit dose. 
     
     
         96 . The kit of  claim 93 , wherein said blister packs are sold separately and said blister packs comprise a first blister pack containing said first composition and a second blister pack containing said second composition. 
     
     
         97 . The kit of  claim 93 , wherein said blister packs containing said first composition and said second composition are advertised as more effective if co-administered. 
     
     
         98 . The kit of  claim 97 , wherein said advertisements are selected from one or more of the group consisting of internet, print, and product packaging advertisements. 
     
     
         99 . A method comprising providing the kit of  claim 63  to patients.