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 versus orally delivered vitamin B complex in reducing serum tHcy levels. DESIGN: Forty-one (41) subjects, between the ages of 50 and 80 years with total serum tHcy concentrations exceeding 11 micromol/L, were treated with a six-week regimen of vitamin B complex. Each B complex consisted of 1000 microg vitamin B12 (as methylcobalamin), 400 microg 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 group SL were given a sublingually delivered vitamin B complex and a matching orally delivered placebo. Members of group PO were given an 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 6-week protocol. RESULTS: There was no statistically significant difference in serum tHcy concentrations between SL and PO groups either before or after treatment, substantiating the idea that there is no difference in efficacy between the two methods of vitamin complex delivery.
RCT Entities:
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 versus orally delivered vitamin B complex in reducing serum tHcy levels. DESIGN: Forty-one (41) subjects, between the ages of 50 and 80 years with total serum tHcy concentrations exceeding 11 micromol/L, were treated with a six-week regimen of vitamin B complex. Each B complex consisted of 1000 microg vitamin B12 (as methylcobalamin), 400 microg 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 group SL were given a sublingually delivered vitamin B complex and a matching orally delivered placebo. Members of group PO were given an 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 6-week protocol. RESULTS: There was no statistically significant difference in serum tHcy concentrations between SL and PO groups either before or after treatment, substantiating the idea that there is no difference in efficacy between the two methods of vitamin complex delivery.