Method for treatment and prevention of deficiencies of vitamins B.sub.12, folic acid, and B.sub.6

• US 5,563,126 A
• Filed: 12/29/1992
• Issued: 10/08/1996
• Est. Priority Date: 11/20/1986
• Status: Expired due to Term

• Current Assignee: Metabolite Laboratories Incorporated
• Original Assignee: Metabolite Laboratories Incorporated
• Inventors: Allen, Robert H., Stabler, Sally P.
• Primary Examiner(s): HENLEY III, RAYMOND J
• Application Number:
  US07/999,499
• Time in Patent Office: 1,379 Days
• Field of Search: 514/52, 514/249, 514/345, 514/814
• 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
• CPC Class Codes: G01N 33/6815 containing sulfur, e.g. cysteine, cystine, methionine, homocysteine
• CPC Class Codes: G01N 33/82 involving vitamins or their receptors

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 eliminate 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 for treating or preventing a deficiency in a host of at least one of cobalamin, folate or B₆ comprising determining the level of at least one metabolite selected from the group consisting of homocysteine, cystathionine, and 2-methylcitric acid, and administering to the host a formulation containing cobalamin, folate and B₆, only if the level of at least one of said metabolites is elevated.

2. The method of claim 1, wherein said administering step includes administering between 0.1 and 10.0 mg cobalamin, between 0.1 and 10 mg of folate, and between 5 and 75 mg B₆.

3. The method of claim 2, wherein said administering step includes administering between 0.1 and 0.4 mg of folate.

4. The method of claim 2, wherein said administering step includes administering between 0.4 and 10 mg of folate.

5. The method of claim 1, wherein said administering step includes administering between 0.1 and 10 mg cobalamin and between 0.1 and 10 mg. folate.

6. The method of claim 5, wherein said administering step includes administering between 0.1 and 0.4 mg of folate.

7. The method of claim 5, wherein said administering step includes administering between 0.4 and 10 mg. of folate.

8. The method of claim 1, wherein said determining step includes determining the level of homocysteine.

9. The method of claim 1, wherein said determining step includes determining the level of cystathionine.

10. The method of claim 1, wherein said determining step includes determining the level of 2-methylcitric acid.