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Aims  To study how  MTHFR   677C→T  genotype modulates the effect of supplementation with B-vitamins on total homocysteine (tHcy) and B-vitamin concentrations.    Methods  2381 patients with a personal history of cardiovascular disease were randomly assigned to one of four groups: 1) B-vitamins alone (560 μg of 5-methyl-THF, 3 mg of vitamin B 6  and 20 μg of vitamin B 12 ), 2) n-3 fatty acids alone (600 mg of EPA and DHA in a 2:1 ratio), 3) B-vitamins and n-3 fatty acids, and 4) placebo. Participants were followed up for 4.7 years. At baseline and annually thereafter, biological parameters were assessed. Multivariate and linear mixed models were fit to study the interaction between B-vitamins and  MTHFR  genotype.    Results  Among supplemented participants, concentrations of all three B-vitamins increased during the first year (all p<0.0001) across  MTHFR  genotype categories. tHcy decreased by 26.3% during the first year (p<0.0001), then steadily increased throughout the 5 years (p trend <0.001). However, at the end of follow-up, that increase was smaller among   TT   than among   CT   or   CC   subjects (p interaction <0.02). At baseline, the difference in tHcy concentrations between   TT   homozygous and   CC   homozygous subjects was 2.33 μmol/l (p<0.001). After 5 years, that difference was reduced to 1.06 μmol/l and remained statistically significant (p<0.001).    Conclusion  Participants with the  TT  genotype exhibited a lower 5-year decrease in tHcy concentrations following a B-vitamin supplementation than did participants with the  CC  or  CT  genotype.    Clinical trial registration  Current Controlled Trials #  ISRCTN41926726 .

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MTHFR 677C → T genotype modulates the effect of a 5-year supplementation with B-vitamins on homocysteine concentration: The SU.FOL.OM3 randomized controlled trial