Effect of folic acid and B vitamins on risk of cardiovascular events and total mortality among women at high risk for cardiovascular disease: a randomized trial.

Study answer

What this study found

The folic acid and B vitamin combination did not reduce major cardiovascular events or total mortality in this high-risk women’s trial. In the active arm versus placebo, combined major cardiovascular disease occurred in 406 (14.9%) versus 390 (14.3%) participants (RR 1.03, 95% CI 0.90-1.19; P = .65), and total mortality was 250 (9.2%) versus 256 (9.4%) (RR 0.97, 95% CI 0.81-1.15; P = .73). Myocardial infarction, stroke, coronary revascularization, cardiovascular death, and the composite of myocardial infarction, stroke, and cardiovascular death were also not significantly different.…

Study & population

Randomized, placebo-controlled trial in female health professionals in the United States who were age 40 years or older, postmenopausal or not intending pregnancy, and had prior cardiovascular disease or at least 3 cardiac risk factors.

Intervention

Women in the active intervention arm received a daily combination pill containing folic acid 2.5 mg, vitamin B6 50 mg, and vitamin B12 1 mg for about 7 years, compared with placebo.

Key limitation

The trial was conducted in women at high cardiovascular risk, so findings may not generalize beyond this population.

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Original abstract