A Single-center, Double blind, Randomized, Controlled Study to Evaluate the Relative Efficacy of Sublingual and Oral Vitamin B Complex Administration in Reducing Total Serum Homocysteine Levels

Objective: Reports correlating total homocysteine (tHcy) concentrations with arteriosclerosis have become a matter of interest amongst healthcare professionals and the public. Several commercial preparations of vitamin B complexes have been marketed as supplements intended to reduce elevated levels of tHcy. Among these preparations are those that have been specifically designed for sublingual administration. This study is designed to evaluate the relative efficacy of sublingually vs. orally delivered vitamin B complex in reducing serum tHcy levels. Design: Forty-one subjects, between the ages of 50-80 years with total serum tHcy concentrations exceeding 11 µmol/l, were treated with a six-week regimen of vitamin B complex. Each B complex consisted of 1000 µg vitamin B12 (as methylcobalamin), 400 µg folate (as folic acid), and 5 mg vitamin B6 (as pyridoxine HCl). Participants in the study were randomized into two groups designated, retrospectively, as SL and PO. Members of the group SL were given a sublingually delivered vitamin B complex and a matching orally delivered placebo. Members of group PO were given a orally delivered vitamin complex and a matching sublingually delivered placebo. A statistically significant reduction in tHcy values was observed in both groups upon completion of the six-week protocol