Combined calcium and vitamin D supplements

• US 6,509,326 B1
• Filed: 03/14/1997
• Issued: 01/21/2003
• Est. Priority Date: 05/06/1991
• Status: Expired due to Fees

• Current Assignee: The Procter & Gamble Company
• Original Assignee: The Procter & Gamble Company
• Inventors: Smith, Kenneth Thomas, Andon, Mark Benson
• Primary Examiner(s): Criares, Theodore J.
• Application Number:
  US08/818,156
• Time in Patent Office: 2,139 Days
• Field of Search: 514/167, 514/574, 424/602, 562/582
• US Class Current: 514/167
• CPC Class Codes: A23L 2/39 Dry compositions
• CPC Class Codes: A23L 2/52 Adding ingredients adding preservatives A23L2/44
• CPC Class Codes: A23L 33/155 Vitamins A or D
• CPC Class Codes: A23L 33/165 Complexes or chelates
• 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 31/19 Carboxylic acids, e.g. valproic acid salicylic acid A61K31/60
• CPC Class Codes: A61K 31/59 Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems
• CPC Class Codes: A61K 33/06 Aluminium, calcium or magnesium; Compounds thereof , e.g. clay
• CPC Class Codes: A61P 19/08 for bone diseases, e.g. rachitism, Paget's disease
• CPC Class Codes: A61P 19/10 for osteoporosis
• CPC Class Codes: A61P 3/02 Nutrients, e.g. vitamins, minerals
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

Nutritional mineral supplements comprising calcium citrate malate and vitamin D are disclosed. Estrogen can also be used with these supplements. These supplements, which provide at least 25% RDA of calcium and vitamin D are used in addition to the normal diet. These supplements are useful for increasing bone growth and for treating age-related bone loss in humans and animals.

Claims

1. A method of building bone in a human, comprising administering to said human a safe and effective amount of a supplement comprising a synergistically effective amount of calcium citrate malate and a vitamin D material selected from the group consisting of vitamin D₃, vitamin D₂, 25(OH)D₃, 25(OH)D₂, 1α

,25(OH)₂D₃, 1α

,25(OH)₂D₂ and mixtures thereof for a sufficient period of time to increase the absolute skeletal mass of said human by at least about 0.1%.

2. The method of claim 1, wherein said calcium citrate malate is administered at a level of from about 175 milligrams to about 2000 milligrams, on an elemental calcium basis, per day and said vitamin D material is administered at a level equivalent to from about 0.60 micrograms to about 30 micrograms of vitamin D₃ per day.

3. The method of claim 2, wherein said vitamin D material is selected from the group consisting of vitamin D₃, vitamin D₂ and mixtures thereof.

4. The method of claim 3, wherein said period of time is at least about six months.

5. The method of claim 4, wherein said calcium citrate malate is administered at a level of from about 250 milligrams to about 1500 milligrams, on an elemental calcium basis, per day and said vitamin D material is administered at a level equivalent to from about 2.5 micrograms to about 25 micrograms of vitamin D₃ per day.

6. The method of claim 2, wherein said vitamin D material is selected from the group consisting of 25(OH)D₃, 25(OH)D₂ and mixtures thereof.

7. The method of claim 6, wherein said period of time is at least about six months.

8. The method of claim 7, wherein said calcium citrate malate is administered at a level of from about 250 milligrams to about 1500 milligrams, on an elemental calcium basis, per day and said vitamin D material is administered at a level equivalent to from about 2.5 micrograms to about 25 micrograms of vitamin D₃ per day.

9. The method of claim 2, wherein said vitamin D material is selected from the group consisting of 1α

,25(OH)₂D₃, 1α

,25(OH)₂D₂ and mixtures thereof.

10. The method of claim 9, wherein said period of time is at least about six months.

11. The method of claim 10, wherein said calcium citrate malate is administered at a level of from about 250 milligrams to about 1500 milligrams, on an elemental calcium basis, per day and said vitamin D material is administered at a level equivalent to from about 2.5 micrograms to about 25 micrograms of vitamin D₃ per day.

12. The method of claim 2, wherein said period of time is at least about six months.

13. The method of claim 1, wherein said period of time is sufficient to increase the absolute skeletal mass of said human by at least about 0.5%.

14. The method of claim 13, wherein said calcium citrate malate is administered at a level of from about 175 milligrams to about 2000 milligrams, on an elemental calcium basis, per day and said vitamin D material is administered at a level equivalent to from about 0.60 micrograms to about 30 micrograms of vitamin D₃ per day.

15. The method of claim 14, wherein said vitamin D material is selected from the group consisting of vitamin D₃, vitamin D₂ and mixtures thereof.

16. The method of claim 15, wherein said period of time is at least about six months.

17. The method of claim 16, wherein said calcium citrate malate is administered at a level of from about 250 milligrams to about 1500 milligrams, on an elemental calcium basis, per day and said vitamin D material is administered at a level equivalent to from about 2.5 micrograms to about 25 micrograms of vitamin D₃ per day.

18. The method of claim 14, wherein said vitamin D material is selected from the group consisting of 25(OH)D₃, 25(OH)D₂ and mixtures thereof.

19. The method of claim 18, wherein said period of time is at least about six months.

20. The method of claim 19, wherein said calcium citrate malate is administered at a level of from about 250 milligrams to about 1500 milligrams, on an elemental calcium basis, per day and said vitamin D material is administered at a level equivalent to from about 2.5 micrograms to about 25 micrograms of vitamin D₃ per day.

21. The method of claim 14, wherein said vitamin D material is selected from the group consisting of 1α

,25(OH)₂D₃, 1α

,25(OH)₂D₂ and mixtures thereof.

22. The method of claim 21, wherein said period of time is at least about six months.

23. The method of claim 22, wherein said calcium citrate malate is administered at a level of from about 250 milligrams to about 1500 milligrams, on an elemental calcium basis, per day and said vitamin D material is administered at a level equivalent to from about 2.5 micrograms to about 25 micrograms of vitamin D₃ per day.

24. The method of claim 14, wherein said period of time is at least about six months.

49. A method as in one of claims 1-48 in which said supplement is administered in a form selected from the group consisting of a solid dosage form, liquid dosage form, or beverage.

25. A method of reducing fracture risk in a human suffering from age related bone loss, comprising administering to said human a safe and effective amount of a supplement comprising a synergistically effective amount of calcium citrate malate and a vitamin D material selected from the group consisting of vitamin D₃, vitamin D₂, 25(OH)D₃, 25(OH)D₂, 1α

,25(OH)₂D₃, 1α

,25(OH)₂D₂ and mixtures thereof for a sufficient period of time to increase the absolute skeletal mass of said human by at least about 0.1%.

26. The method of claim 25, wherein said calcium citrate malate is administered at a level of from about 175 milligrams to about 2000 milligrams, on an elemental calcium basis, per day and said vitamin D material is administered at a level equivalent to from about 0.60 micrograms to about 30 micrograms of vitamin D₃ per day.

27. The method of claim 26, wherein said vitamin D material is selected from the group consisting of vitamin D₃, vitamin D₂ and mixtures thereof.

28. The method of claim 25, wherein said period of time is at least about six months.

29. The method of claim 28, wherein said calcium citrate malate is administered at a level of from about 250 micrograms to about 1500 milligrams, on an elemental calcium basis, per day and said vitamin D material is administered at a level equivalent to from about 2.5 micrograms to about 25 micrograms of vitamin D₃ per day.

30. The method of claim 25, wherein said vitamin D material is selected from the group consisting of 25(OH)D₃, 25(OH)D₂ and mixtures thereof.

31. The method of claim 30, wherein said period of time is at least about six months.

32. The method of claim 31, wherein said calcium citrate malate is administered at a level of from about 250 milligrams to about 1500 milligrams, on an elemental calcium basis, per day and said vitamin D material is administered at a level equivalent to from about 2.5 micrograms to about 25 micrograms of vitamin D₃ per day.

33. The method of claim 25, wherein said vitamin D material is selected from the group consisting of 1α

,25(OH)₂D₃, 1α

,25(OH)₂D₂ and mixtures thereof.

34. The method of claim 33, wherein said period of time is at least about six months.

35. The method of claim 34, wherein said calcium citrate malate is administered at a level of from about 250 milligrams to about 1500 milligrams, on an elemental calcium basis, per day and said vitamin D material is administered at a level equivalent to from about 2.5 micrograms to about 25 micrograms of vitamin D₃ per day.

36. The method of claim 26, wherein said period of time is at least about six months.

37. The method of claim 25, wherein said period of time is sufficient to increase the absolute skeletal mass of said human by at least about 0.5%.

38. The method of claim 37, wherein said calcium citrate malate is administered at a level of from about 175 milligrams to about 2000 milligrams, on an elemental calcium basis, per day and said vitamin D material is administered at a level equivalent to from about 0.60 micrograms to about 30 micrograms of vitamin D₃ per day.

39. The method of claim 38, wherein said vitamin D material is selected from the group consisting of vitamin D₃, vitamin D₂ and mixtures thereof.

40. The method of claim 39, wherein said period of time is at least about six months.

41. The method of claim 40, wherein said calcium citrate malate is administered at a level of from about 250 milligrams to about 1500 milligrams, on an elemental calcium basis, per day and said vitamin D material is administered at a level equivalent to from about 2.5 micrograms to about 25 micrograms of vitamin D₃ per day.

42. The method of claim 38, wherein said vitamin D material is selected from the group consisting of 25(OH)D₃, 25(OH)D₂ and mixtures thereof.

43. The method of claim 42, wherein said period of time is at least about six months.

44. The method of claim 43, wherein said calcium citrate malate is administered at a level of from about 250 milligrams to about 1500 milligrams, on an elemental calcium basis, per day and said vitamin D material is administered at a level equivalent to from about 2.5 micrograms to about 25 micrograms of vitamin D₃ per day.

45. The method of claim 38, wherein said vitamin D material is selected from the group consisting of 1α

,25(OH)₂D₃, 1α

,25(OH)₂D₂ and mixtures thereof.

46. The method of claim 45, wherein said period of time is at least about six months.

47. The method of claim 46, wherein said calcium citrate malate is administered at a level of from about 250 milligrams to about 1500 milligrams, on an elemental calcium basis, per day and said vitamin D material is administered at a level equivalent to from about 2.5 micrograms to about 25 micrograms of vitamin D₃ per day.

48. The method of claim 38, wherein said period of time is at least about six months.

50. A mineral supplements for building bones, comprising a unit dosage mixture of:

a) from about 100 milligrams to about 1000 milligrams of calcium, on an elemental basis, in the form of calcium malate; and

b) an amount of vitamin D material, selected from the group consisting of vitamin D₃, vitamin D₂, 25(OH)D₃, 25(OH)D₂, 1α

,25(OH)₂D₃, 1α

,25(OH)₂D₂ and mixtures thereof, equivalent to from about 0.6 micrograms to about 30 micrograms of vitamin D₃;

wherein the calcium and vitamin D material are included in a synergistically effective amount.

51. The mineral supplement of claim 50, wherein said amount of vitamin D material is equivalent to from about 0.6 micrograms to about 20 micrograms of vitamin D₃.

52. The mineral supplement of claim 50, wherein said amount of vitamin D material is selected from the group consisting of vitamin D₃, vitamin D₂ and mixtures thereof.

53. The mineral supplement of claim 50, wherein said amount of vitamin D material is selected from the group consisting of vitamin D₃, vitamin D₂, 25(OH)D₃, 25(OH)D₂ and mixtures thereof.

54. The mineral supplement of claim 50, wherein said amount of vitamin D material is selected from the group consisting of 1α

,25(OH)₂D₃, 1α

,25(OH)₂D₂ and mixtures thereof.

55. The mineral supplement of claim 54 comprising greater than 5 micrograms but less than or equal to about 15 micrograms of vitamin D material.

56. The mineral supplement of claim 54 comprising from about 200 milligrams to about 300 milligrams of calcium on an elemental basis in the form of calcium citrate malate.

57. A beverage comprising a synergistically effective amount of:

a) calcium in the form of calcium citrate malate; and

b) a vitamin D material selected from the group consisting of vitamin D₃, vitamin D₂, 25(OH)D₃, 25(OH)D₂, 1α

,25(OH)₂D₃, 1α

,25(OH)₂D₂.