Method for treatment, preventing and reduction of elevated serum metabolite levels

• US 6,297,224 B1
• Filed: 03/22/1999
• Issued: 10/02/2001
• Est. Priority Date: 12/29/1992
• Status: Expired due to Fees

• Current Assignee: Metabolite Laboratories Incorporated
• Original Assignee: Metabolite Laboratories Incorporated
• Inventors: Allen, Robert H., Stabler, Sally P.
• Primary Examiner(s): Scheiner, Laurie
• Assistant Examiner(s): PARKIN, JEFFREY S
• Application Number:
  US09/273,754
• Time in Patent Office: 925 Days
• Field of Search: 514/52, 514/249, 514/345
• US Class Current: 514/52
• 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 31/525 Isoalloxazines, e.g. riboflavins, vitamin B2
• CPC Class Codes: A61K 31/714 Cobalamins, e.g. cyanocobalamin, i.e. vitamin B12

Abstract

A method for orally administering vitamin preparations is described which combine vitamin B₁₂ (B₁₂, cobalamin) and folic acid (folate), with and without pyridoxine (B₆), for preventing and treating elevated serum homocysteine (HC), cystathionine (CT), methylmalonic acid (MMA), or 2-methylcitric acid (2-MCA) levels. These metabolites have been shown to be indicative of B₁₂ and/or folic acid deficiencies. Further, it is likely that a B₆ deficiency may be present with a B₁₂ or folate deficiency. The method of the invention is also for use in lowering serum HC, CT, MMA, or 2-MCA in patients with or at risk for neuropsychiatric, vascular, renal or hematologic diseases. One embodiment of the invention is the use of a non-prescription formulation containing 2.0 mg B₁₂ and 0.4 mg folic acid, with and without 25 mg B₆. Another embodiment uses a prescription strength formulation containing 2.0 mg B₁₂ and 1.0 mg folic acid, with and without 25 mg B₆. The method of the present invention eliminates the costly and time consuming steps of distinguishing between vitamin deficiencies once a deficiency is found by measurement of serum metabolite levels. The present invention is of particular benefit to the populations at risk for elevated serum metabolite levels, such as the people over the age of 65, and populations that have or are at risk for neuropsychiatric, vascular, renal and hematologic diseases.

Claims

1. A method of treating or preventing elevated serum metabolite levels of at least one of homocysteine, methylmalonic acid, cystathionine, or 2-methylcitric acid comprising periodically administering orally a single formulation containing vitamin B₁₂ and folic acid.

2. The method of claim 1, wherein said metabolite is homocysteine.

3. The method of claim 1, wherein said metabolite is methylmalonic acid.

4. The method of claim 1, wherein said metabolite is cystathionine.

5. The method of claim 1, wherein said metabolite is 2-methylcitric acid.

6. A method of treating or preventing elevated serum metabolite levels of at least one of homocysteine, methylmalonic acid, cystathionine, or 2-methylcitric acid comprising periodically administering orally a single formulation containing vitamin B₁₂, folic acid, and vitamin B₆.

7. The method of claim 6, wherein said metabolite is homocysteine.

8. The method of claim 6, wherein said metabolite is methylmalonic acid.

9. The method of claim 6, wherein said metabolite is cystathionine.

10. The method of claim 6, wherein said metabolite is 2-methylcitric acid.

11. A method of lowering serum metabolite levels of at least one of homocysteine, methylmalonic acid, cystathionine, or 2-methylcitric acid comprising periodically administering orally a single formulation containing vitamin B₁₂, and folic acid.

12. The method of claim 11, wherein said metabolite is homocysteine.

13. The method of claim 11, wherein said metabolite is methylmalonic acid.

14. The method of claim 11, wherein said metabolite is cystathionine.

15. The method of claim 11, wherein said metabolite is 2-methylcitric acid.

16. A method of lowering serum metabolite levels of at least one of homocysteine, methylmalonic acid, cystathionine, or 2-methylcitric acid comprising periodically administering orally a single formulation containing vitamin B₁₂, folic acid, and vitamin B₆.

17. The method of claim 16, wherein said metabolite is homocysteine.

18. The method of claim 16, wherein said metabolite is methylmalonic acid.

19. The method of claim 16, wherein said metabolite is cystathionine.

20. The method of claim 16, wherein said metabolite is 2-methylcitric acid.