Compositions and methods for nutrition supplementation

• US 20060034912A1
• Filed: 08/12/2004
• Published: 02/16/2006
• Est. Priority Date: 08/12/2004
• Status: Active Grant

• Current Assignee: Exeltis USA, Inc. (Chemo Iberica, S.A.)
• Original Assignee: Everett Laboratories Incorporated (Chemo Iberica, S.A.)
• Inventors: Giordano, John A., Balzer, Charles J.
• Granted Patent: US 7,560,123 B2
• Time in Patent Office: Days
• US Class Current: 424/464
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/015 carbocyclic
• CPC Class Codes: A61K 31/07 Retinol compounds, e.g. vitamin A retinoic acids A61K31/203
• CPC Class Codes: A61K 31/355 Tocopherols, e.g. vitamin E
• CPC Class Codes: A61K 31/375 Ascorbic acid, i.e. vitamin C; Salts thereof
• CPC Class Codes: A61K 31/4406 only substituted in position 3, e.g. zimeldine nicotinic acid A61K31/455
• CPC Class Codes: A61K 31/4415 Pyridoxine, i.e. Vitamin B6 pyridoxal phosphate A61K31/675
• CPC Class Codes: A61K 31/455 Nicotinic acids, e.g. niacin; Derivatives thereof, e.g. esters, amides
• CPC Class Codes: A61K 31/51 Thiamines, e.g. vitamin B1
• CPC Class Codes: A61K 31/519 ortho- or peri-condensed with heterocyclic rings
• CPC Class Codes: A61K 31/525 Isoalloxazines, e.g. riboflavins, vitamin B2
• CPC Class Codes: A61K 31/593 9,10-Secocholestane derivatives, e.g. cholecalciferol, i.e. vitamin D3
• CPC Class Codes: A61K 31/714 Cobalamins, e.g. cyanocobalamin, i.e. vitamin B12
• CPC Class Codes: A61K 31/715 Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
• CPC Class Codes: A61K 33/06 Aluminium, calcium or magnesium; Compounds thereof , e.g. clay
• CPC Class Codes: A61K 33/08 Oxides; Hydroxides
• CPC Class Codes: A61K 33/26 Iron; Compounds thereof
• CPC Class Codes: A61K 33/30 Zinc; Compounds thereof
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 47/34 Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers A61K47/10 takes precedence
• CPC Class Codes: A61K 9/0053 : Mouth and digestive tract, i.e. intraoral and peroral administration rectal administration A61K9/0031
• CPC Class Codes: A61K 9/0056 : Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
• CPC Class Codes: A61P 3/02 : Nutrients, e.g. vitamins, minerals

Abstract

The present invention relates to compositions that may be swallowable, chewable or dissolvable, comprising various vitamins and minerals, and in a specific embodiment comprising vitamin A, beta carotene, B-complex vitamins, vitamin C, vitamin D₃, vitamin E, iron, magnesium and zinc, and methods for using these compositions for nutritional supplementation in subjects undergoing physiologically stressful events, such as, for example and without limitation, pregnancy, lactation or any disease state.

Claims

1. A composition comprising vitamin A, beta carotene, B-complex vitamins, vitamin C, vitamin D₃, vitamin E, iron, magnesium and zinc, wherein said composition is administrable to a patient.

2. The composition of claim 1, wherein said composition is in a swallowable form.

3. The composition of claim 1, wherein said composition is in a chewable form.

4. The composition of claim 1, wherein said composition is in a dissolvable form.

5. The composition of claim 1, wherein said vitamin A comprises acetate.

6. The composition of claim 1, wherein said B-complex vitamins comprise one or more the vitamins selected from the group consisting of vitamin B₁, vitamin B₂, vitamin B₃, vitamin B₆, vitamin B₉ and vitamin B₁₂.

7. The composition of claim 6, wherein said vitamin B₁ comprises thiamine mononitrate.

8. The composition of claim 6, wherein said vitamin B₂ comprises riboflavin.

9. The composition of claim 6, wherein said vitamin B₃ comprises niacinamide.

10. The composition of claim 6, wherein said vitamin B₃ comprises an equivalent molar amount of niacin.

11. The composition of claim 6, wherein said vitamin B₆ comprises pyridoxine hydrochloride.

12. The composition of claim 6, wherein said vitamin B₉ comprises folic acid.

13. The composition of claim 6, wherein said vitamin B₉ comprises folacin.

14. The composition of claim 6, wherein said vitamin B₉ comprises metafolin.

15. The composition of claim 6, wherein said vitamin B₉ comprises folate.

16. The composition of claim 6, wherein said vitamin B₉ comprises one or more natural isomers of folate 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.

17. The composition of claim 6, wherein said vitamin B₁₂ comprises cyanocobalamin.

18. The composition of claim 1, wherein said vitamin C comprises ascorbic acid.

19. The composition of claim 1, wherein said vitamin D₃ comprises cholecalciferol.

20. The composition of claim 1, wherein said vitamin E comprises d-alpha tocopheryl acetate.

21. The composition of claim 1, wherein said vitamin E comprises d-alpha tocopheryl succinate.

22. The composition of claim 1, wherein said iron comprises ferrous fumarate.

23. The composition of claim 1, wherein said iron comprises polysaccharide complex.

24. The composition of claim 1, wherein said magnesium comprises magnesium oxide.

25. The composition of claim 1, wherein said zinc comprises zinc oxide.

26. The composition of claim 1, wherein said composition is substantially free of other added vitamins and minerals.

27. The composition of claim 1, further comprising a pharmaceutically acceptable carrier.

28. The composition of claim 27, wherein said pharmaceutically acceptable carrier is selected from one or more of the group consisting of binders, diluents, lubricants, glidants, colorants, emulsifiers, disintegrants, starches, water, oils, alcohols, preservatives and sugars.

29. The composition of claim 1, further comprising a sweetening agent.

30. The composition of claim 29, wherein said sweetening agent is selected from one or more of the group consisting of sucrose, fructose, high fructose corn syrup, dextrose, saccharin sodium, maltodextrin, aspartame, potassium acesulfame, neohesperidin dihydrochalcone, sucralose, monoammonium glycyrrhizinate, and mixtures thereof.

31. The composition of claim 1, further comprising a flavorant.

32. The composition of claim 31, wherein said flavorant is selected from one or more of the group consisting of a natural flavor oil, a synthetic flavor oil, a citrus oil, a fruit essence, an extract from a plant, an extract from a leaf, an extract from a flower, an extract from a fruit, a synthetic flavor and a combination thereof.

33. The composition of claim 31, wherein said flavorant is selected from one or more of the group consisting of anise oil, cinnamon oil, peppermint oil, oil of wintergreen, clove oil, bay oil, anise oil, eucalyptus oil, thyme oil, cedar leave oil, oil of nutmeg, oil of sage, oil of bitter almonds, cassia oil, lemon oil, orange oil, lime oil, grapefruit oil, grape oil and a combination thereof.

34. The composition of claim 31, wherein said flavorant is selected from one or more of the group consisting of apple essence, pear essence, peach essence, berry essence, wildberry essence, date essence, blueberry essence, kiwi essence, strawberry essence, raspberry essence, cherry essence, plum essence, pineapple essence, and apricot essence.

35. The composition of claim 31, wherein said flavorant is selected from one or more of the group consisting of natural mixed berry flavor, citric acid, malic acid, vanilla, vanillin, cocoa, chocolate, and menthol.

36. The composition of claim 1, wherein said composition further comprises alkyl polysiloxane in an amount of about 0.05 weight percent to less than about one weight percent of the composition.

37. The composition of claim 36, wherein said alkyl polysiloxane is in the form of dimethyl polysiloxane.

38. The composition of claim 1, wherein said composition further comprises fructose, stearic acid, natural mixed berry flavor, croscarmellose sodium, citric acid, magnesium stearate, silicon dioxide, and malic acid.

39. The composition of claim 1, wherein said vitamin A is present in the range of about 550 IU to about 1650 IU.

40. The composition of claim 1, wherein said beta carotene is present in the range of about 300 IU to about 900 IU.

41. The composition of claim 6, wherein said vitamin B₁ is present in the range of about 1 mg to about 3 mg.

42. The composition of claim 6, wherein said vitamin B₂ is present in the range of about 1 mg to about 3 mg.

43. The composition of claim 6, wherein said vitamin B₃ is present in the range of about 7 mg to about 23 mg.

44. The composition of claim 6, wherein said vitamin B₆ is present in the range of about 1 mg to about 4 mg.

45. The composition of claim 6, wherein said vitamin B₉ is present in the range of about 500 μ

g to about 1500 μ

g.

46. The composition of claim 6, wherein said vitamin B₁₂ is present in the range of about 2 μ

g to about 8 μ

g.

47. The composition of claim 1, wherein said vitamin C is present in the range of about 30 mg to about 90 mg.

48. The composition of claim 1, wherein said vitamin D₃ is present in the range of about 200 IU to about 600 IU.

49. The composition of claim 1, wherein said vitamin E is present in the range of about 15 IU to about 45 IU.

50. The composition of claim 1, wherein said iron is present in the range of about 14 mg to about 44 mg.

51. The composition of claim 1, wherein said magnesium is present in the range of about 12 mg to about 38 mg.

52. The composition of claim 1, wherein said zinc is present in the range of about 7 mg to about 23 mg.

53. The composition of claim 1, wherein said composition comprises about 550 IU to about 1650 IU vitamin A;

about 300 IU to about 900 IU beta carotene;

about 1 mg to about 3 mg vitamin B₁;

about 1 mg to about 3 mg vitamin B₂;

about 7 mg to about 23 mg vitamin B₃;

about 1 mg to about 4 mg vitamin B₆;

about 500 μ

g to about 1500 μ

g vitamin B₉;

about 2 μ

g to about 8 μ

g vitamin B₁₂;

about 30 mg to about 90 mg vitamin C;

about 200 IU to about 600 IU vitamin D₃;

about 15 IU to about 45 IU vitamin E;

about 14 mg to about 44 mg iron;

about 12 mg to about 38 mg magnesium; and

/or about 7 mg to about 23 mg zinc.

54. The composition of claim 1, wherein said composition comprises about 880 IU to about 1320 IU vitamin A;

about 480 IU to about 720 IU beta carotene;

about 1.3 mg to about 1.9 mg vitamin B₉;

about 1.5 mg to about 2.2 mg vitamin B₂;

about 12 mg to about 18 mg vitamin B₃;

about 2 mg to about 3 mg vitamin B₆;

about 800 μ

g to about 1200 μ

g vitamin B₉;

about 4 μ

g to about 6 μ

g vitamin B₁₂;

about 48 mg to about 72 mg vitamin C;

about 320 IU to about 480 IU vitamin D₃;

about 24 IU to about 36 IU vitamin E;

about 23 mg to about 35 mg iron;

about 20 mg to about 30 mg magnesium; and

about 12 mg to about 18 mg zinc.

55. The composition of claim 1, wherein said composition comprises about 990 IU to about 1210 IU vitamin A;

about 540 IU to about 660 IU beta carotene;

about 1.5 mg to about 1.75 mg vitamin B₁;

about 1.6 mg to about 2 mg vitamin B₂;

about 13.5 mg to about 16.5 mg vitamin B₃;

about 2.3 mg to about 2.8 mg vitamin B₆;

about 900 μ

g to about 1100 μ

g vitamin B₉;

about 4.5 μ

g to about 5.5 μ

g vitamin B₁₂;

about 54 mg to about 66 mg vitamin C;

about 360 IU to about 440 IU vitamin D₃;

about 27 IU to about 33 IU vitamin E;

about 26 mg to about 32 mg iron;

about 22.5 mg to about 27.5 mg magnesium; and

about 13.5 mg to about 16.5 mg zinc.

56. The composition of claim 1, wherein said vitamin A is present in the amount of about 1100 IU.

57. The composition of claim 1, wherein said beta carotene is present in the range of about 600 IU.

58. The composition of claim 6, wherein said vitamin B₁ is present in the amount of about 1.6 mg.

59. The composition of claim 6, wherein said vitamin B₂ is present in the amount of about 1.8 mg.

60. The composition of claim 6, wherein said vitamin B₃ is present in the amount of about 15 mg.

61. The composition of claim 6, wherein said vitamin B₆ is present in the amount of about 2.5 mg.

62. The composition of claim 6, wherein said vitamin B₉ is present in the amount of about 1000 μ

g.

63. The composition of claim 6, wherein said vitamin B₁₂ is present in the amount of about 5 μ

g.

64. The composition of claim 1, wherein said vitamin C is present in the amount of about 60 mg.

65. The composition of claim 1, wherein said vitamin D₃ is present in the amount of about 400 IU.

66. The composition of claim 1, wherein said vitamin E is present in the amount of about 30 IU.

67. The composition of claim 1, wherein said iron is present in the amount of about 29 mg.

68. The composition of claim 1, wherein said magnesium is present in the amount of about 25 mg.

69. The composition of claim 1, wherein said zinc is present in the amount of about 15 mg.

70. The composition of claim 1, wherein said composition comprises about 1100 IU vitamin A;

about 600 IU beta carotene;

about 1.6 mg vitamin B₁;

about 1.8 mg vitamin B₂;

about 15 mg vitamin B₃;

about 2.5 mg vitamin B₆;

about 1000 μ

g vitamin B₉;

about 5 μ

g vitamin B₁₂;

about 60 mg vitamin C;

about 400 IU vitamin D₃;

about 30 IU vitamin E;

about 29 mg iron;

about 25 mg magnesium; and

about 15 mg zinc.

71. The composition of claim 1, wherein said patient is pregnant.

72. The composition of claim 1, wherein said patient is lactating.

73. The composition of claim 1, wherein said patient has nutritional deficiencies.

74. The composition of claim 73, wherein said nutritional deficiencies are a result of pregnancy.

75. The composition of claim 73, wherein said nutritional deficiencies are a result of lactation.

76. The composition of claim 73, wherein said nutritional deficiencies are a result of elevated metabolic demand.

77. The composition of claim 73, wherein said nutritional deficiencies are a result of increased plasma volume.

78. The composition of claim 73, wherein said nutritional deficiencies are a result of decreased concentrations of nutrient-binding proteins.

79. The composition of claim 78, wherein said nutrient-binding proteins comprise one or more of the proteins selected from the group consisting of serum-ferritin, maltose-binding protein, lactoferrin, calmodulin, tocopheryl binding protein, riboflavin binding protein, retinal binding protein, transthyretin, high density lipoprotein-apolipoprotein A1, folic acid binding protein, and 25-hydroxyvitamin D binding protein.

80. A method comprising administering a composition comprising vitamin A, beta carotene, B-complex vitamins, vitamin C, vitamin D₃, vitamin E, iron, magnesium and zinc, to supplement nutritional deficiencies in a patient.

81. The method of claim 80, wherein said composition is in a swallowable form.

82. The method of claim 80, wherein said composition is in a chewable form.

83. The method of claim 80, wherein said composition is in a dissolvable form.

84. The method of claim 80, wherein said vitamin A comprises acetate.

85. The method of claim 80, wherein said B-complex vitamins comprise one or more vitamins selected from the group consisting of vitamin B₁, vitamin B₂, vitamin B₆, niacinamide, folic acid and vitamin B₁₂.

86. The method of claim 85, wherein said vitamin B₁ comprises thiamine mononitrate.

87. The method of claim 85, wherein said vitamin B₂ comprises riboflavin.

88. The method of claim 85, wherein said B₃ comprises niacinamide.

89. The method of claim 85, wherein said B₃ comprises an equivalent molar amount of niacin.

90. The method of claim 85, wherein said vitamin B₆ comprises pyridoxine hydrochloride.

91. The method of claim 85, wherein said vitamin B₉ comprises folic acid.

92. The method of claim 85, wherein said vitamin B₉ comprises folacin.

93. The method of claim 85, wherein said vitamin B₉ comprises metafolin.

94. The method of claim 85, wherein said vitamin B₉ comprises folate.

95. The method of claim 85, wherein said vitamin B₉ comprises one or more natural isomers of folate 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.

96. The method of claim 85, wherein said vitamin B₁₂ comprises cyanocobalamin.

97. The method of claim 80, wherein said vitamin C comprises ascorbic acid.

98. The method of claim 80, wherein said vitamin D₃ comprises cholecalciferol.

99. The method of claim 80, wherein said vitamin E comprises d-alpha tocopheryl acetate.

100. The method of claim 80, wherein said vitamin E comprises d-alpha tocopheryl succinate.

101. The method of claim 80, wherein said iron comprises ferrous fumarate.

102. The method of claim 80, wherein said iron comprises polysaccharide complex.

103. The method of claim 80, wherein said magnesium comprises magnesium oxide.

104. The method of claim 80, wherein said zinc comprises zinc oxide.

105. The method of claim 80, wherein said composition is substantially free of other added vitamins and minerals.

106. The method of claim 80, further comprising a pharmaceutically acceptable carrier.

107. The method of claim 106, wherein said pharmaceutically acceptable carrier is selected from one or more of the group consisting of binders, diluents, lubricants, glidants, colorants, emulsifiers, disintegrants, starches, water, oils, alcohols, preservatives and sugars.

108. The method of claim 80, further comprising a sweetening agent.

109. The method of claim 108, wherein said sweetening agent is selected from one or more of the group consisting of sucrose, fructose, high fructose corn syrup, dextrose, saccharin sodium, maltodextrin, aspartame, potassium acesulfame, neohesperidin dihydrochalcone, sucralose, monoammonium glycyrrhizinate, and mixtures thereof.

110. The method of claim 80, further comprising a flavorant.

111. The method of claim 110, wherein said flavorant is selected from one or more of the group consisting of a natural flavor oil, a synthetic flavor oil, a citrus oil, a fruit essence, an extract from a plant, an extract from a leaf, an extract from a flower, an extract from a fruit, a synthetic flavor and a combination thereof.

112. The method of claim 110, wherein said flavorant is selected from one or more of the group consisting of anise oil, cinnamon oil, peppermint oil, oil of wintergreen, clove oil, bay oil, anise oil, eucalyptus oil, thyme oil, cedar leave oil, oil of nutmeg, oil of sage, oil of bitter almonds, cassia oil, lemon oil, orange oil, lime oil, grapefruit oil, grape oil and a combination thereof.

113. The method of claim 110, wherein said flavorant is selected from one or more of the group consisting of apple essence, pear essence, peach essence, berry essence, wildberry essence, date essence, blueberry essence, kiwi essence, strawberry essence, raspberry essence, cherry essence, plum essence, pineapple essence, and apricot essence.

114. The method of claim 110, wherein said flavorant is selected from one or more of the group consisting of natural mixed berry flavor, citric acid, malic acid, vanilla, vanillin, cocoa, chocolate, and menthol.

115. The method of claim 80, wherein said composition further comprises alkyl polysiloxane in an amount of about 0.05 weight percent to less than about one weight percent of the composition.

116. The method of claim 115, wherein said alkyl polysiloxane is in the form of dimethyl polysiloxane.

117. The method of claim 80, wherein said composition further comprises fructose, stearic acid, natural mixed berry flavor, croscarmellose sodium, citric acid, magnesium stearate, silicon dioxide, and malic acid.

118. The method of claim 80, wherein said vitamin A is present in the range of about 550 IU to about 1650 IU.

119. The method of claim 80, wherein said beta carotene is present in the range of about 300 IU to about 900 IU.

120. The method of claim 85, wherein said vitamin B₁ is present in the range of about 1 mg to about 3 mg.

121. The method of claim 85, wherein said vitamin B₂ is present in the range of about 1 mg to about 3 mg.

122. The method of claim 85, wherein said vitamin B₃ is present in the range of about 7 mg to about 23 mg.

123. The method of claim 85, wherein said vitamin B₆ is present in the range of about 1 mg to about 4 mg.

124. The method of claim 85, wherein said vitamin B₉ is present in the range of about 500 μ

g to about 1500 μ

g.

125. The method of claim 85, wherein said vitamin B₁₂ is present in the range of about 2 μ

g to about 8 μ

g.

126. The method of claim 80, wherein said vitamin C is present in the range of about 30 mg to about 90 mg.

127. The method of claim 80, wherein said vitamin D₃ is present in the range of about 200 IU to about 600 IU.

128. The method of claim 80, wherein said vitamin E is present in the range of about 15 IU to about 45 IU.

129. The method of claim 80, wherein said iron is present in the range of about 14 mg to about 44 mg.

130. The method of claim 80, wherein said magnesium is present in the range of about 12 mg to about 38 mg.

131. The method of claim 80, wherein said zinc is present in the range of about 7 mg to about 23 mg.

132. The method of claim 80, wherein said composition comprises about 550 IU to about 1650 IU vitamin A;

about 300 IU to about 900 IU beta carotene;

about 1 mg to about 3 mg vitamin B₁;

about 1 mg to about 3 mg vitamin B₂;

about 7 mg to about 23 mg vitamin B₃;

about 1 mg to about 4 mg vitamin B₆;

about 500 μ

g to about 1500 μ

g vitamin B₉;

about 2 μ

g to about 8 μ

g vitamin B₁₂;

about 30 mg to about 90 mg vitamin C;

about 200 IU to about 600 IU vitamin D₃;

about 15 IU to about 45 IU vitamin E;

about 14 mg to about 44 mg iron;

about 12 mg to about 38 mg magnesium; and

/or about 7 mg to about 23 mg zinc.

133. The method of claim 80, wherein said composition comprises about 880 IU to about 1320 IU vitamin A;

about 480 IU to about 720 IU beta carotene;

about 1.3 mg to about 1.9 mg vitamin B₁;

about 1.5 mg to about 2.2 mg vitamin B₂;

about 12 mg to about 18 mg vitamin B₃;

about 2 mg to about 3 mg vitamin B₆;

about 800 μ

g to about 1200 μ

g vitamin B₉;

about 4 μ

g to about 6 μ

g vitamin B₁₂;

about 48 mg to about 72 mg vitamin C;

about 320 IU to about 480 IU vitamin D₃;

about 24 IU to about 36 IU vitamin E;

about 23 mg to about 35 mg iron;

about 20 mg to about 30 mg magnesium; and

about 12 mg to about 18 mg zinc.

134. The method of claim 80, wherein said composition comprises about 990 IU to about 1210 IU vitamin A;

about 540 IU to about 660 IU beta carotene;

about 1.5 mg to about 1.75 mg vitamin B₁;

about 1.6 mg to about 2 mg vitamin B₂;

about 13.5 mg to about 16.5 mg vitamin B₃;

about 2.3 mg to about 2.8 mg vitamin B₆;

about 900 μ

g to about 1100 μ

g vitamin B₉;

about 4.5 μ

g to about 5.5 μ

g vitamin B₁₂;

about 54 mg to about 66 mg vitamin C;

about 360 IU to about 440 IU vitamin D₃;

about 27 IU to about 33 IU vitamin E;

about 26 mg to about 32 mg iron;

about 22.5 mg to about 27.5 mg magnesium; and

about 13.5 mg to about 16.5 mg zinc.

135. The method of claim 80, wherein said vitamin A is present in the amount of about 1100 IU.

136. The method of claim 80, wherein said beta carotene is present in the range of about 600 IU.

137. The method of claim 85, wherein said vitamin B₁ is present in the amount of about 1.6 mg.

138. The method of claim 85, wherein said vitamin B₂ is present in the amount of about 1.8 mg.

139. The method of claim 85, wherein said vitamin B₃ is present in the amount of about 15 mg.

140. The method of claim 85, wherein said vitamin B₆ is present in the amount of about 2.5 mg.

141. The method of claim 85, wherein said vitamin B₉ is present in the amount of about 1000 μ

g.

142. The method of claim 85, wherein said vitamin B₁₂ is present in the amount of about 5 μ

g.

143. The method of claim 80, wherein said vitamin C is present in the amount of about 60 mg.

144. The method of claim 80, wherein said vitamin D₃ is present in the amount of about 400 IU.

145. The method of claim 80, wherein said vitamin E is present in the amount of about 30 IU.

146. The method of claim 80, wherein said iron is present in the amount of about 29 mg.

147. The method of claim 80, wherein said magnesium is present in the amount of about 25 mg.

148. The method of claim 80, wherein said zinc is present in the amount of about 15 mg.

149. The method of claim 80, wherein said composition comprises about 1100 IU vitamin A;

about 600 IU beta carotene;

about 1.6 mg vitamin B₁;

about 1.8 mg vitamin B₂;

about 15 mg vitamin B₃;

about 2.5 mg vitamin B₆;

about 1000 μ

g vitamin B₉;

about 60 mg vitamin C;

about 400 IU vitamin D₃;

about 30 IU vitamin E;

about 29 mg iron;

about 25 mg magnesium; and

about 15 mg zinc.

150. The method of claim 80, wherein said patient is pregnant.

151. The method of claim 80, wherein said patient is lactating.

152. The method of claim 80, wherein said patient has nutritional deficiencies.

153. The method of claim 152, wherein said nutritional deficiencies are a result of pregnancy.

154. The method of claim 152, wherein said nutritional deficiencies are a result of lactation.

155. The method of claim 152, wherein said nutritional deficiencies are a result of elevated metabolic demand.

156. The method of claim 152, wherein said nutritional deficiencies are a result of increased plasma volume.

157. The method of claim 152, wherein said nutritional deficiencies are a result of decreased concentrations of nutrient-binding proteins.

158. The method of claim 157, wherein said nutrient-binding proteins comprise one or more proteins selected from the group consisting of serum-ferritin, maltose-binding protein, lactoferrin, calmodulin, tocopheryl binding protein, riboflavin binding protein, retinal binding protein, transthyretin, high density lipoprotein-apolipoprotein A1, folic acid binding protein, and 25-hydroxyvitamin D binding protein.