Effect of physiological doses of oral vitamin B12 on plasma homocysteine: a randomized, placebo-controlled, double-blind trial in India

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Background/Objectives:Vitamin B12 (B12) deficiency is common in Indians and a major contributor to hyperhomocysteinemia, which may influence fetal growth, risk of type II diabetes and cardiovascular disease. The purpose of this paper was to study the effect of physiological doses of B12 and folic acid on plasma total homocysteine (tHcy) concentration.Subjects/Methods:A cluster randomized, placebo-controlled, double-blind, 2×3 factorial trial, using the family as the randomization unit. B12 was given as 2 or 10 μg capsules, with or without 200 μg folic acid, forming six groups (B0F0, B2F0, B10F0, B0F200, B2F200 and B10F200). Plasma tHcy concentration was measured before and after 4 and 12 months of supplementation.Results:From 119 families in the Pune Maternal Nutrition Study, 300 individuals were randomized. There was no interaction between B12 and folic acid (P=0.14) in relation to tHcy concentration change and their effects were analyzed separately: B0 vs. B2 vs. B10; and F0 vs. F200. At 12 months, tHcy concentration reduced by a mean 5.9 (95% CI: −7.8, −4.1) μmol/l in B2, and by 7.1 (95% CI: −8.9, −5.4) μmol/l in B10, compared to nonsignificant rise of 1.2 (95% CI: −0.5, 2.9) μmol/l in B0. B2 and B10 did not differ significantly. In F200, tHcy concentration decreased by 4.8 (95% CI: −6.3, −3.3) μmol/l compared to 2.8 (95% CI: −4.3, −1.2) μmol/l in F0.Conclusion:Daily oral supplementation with physiological doses of B12 is an effective community intervention to reduce tHcy. Folic acid (200 μg per day) showed no additional benefit, neither had any unfavorable effects.

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