NORVITNorwegian Vitamin Trial
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[4] Nonstandard abbreviations: WENBIT, Western Norway B Vitamin Intervention Trial; NORVIT, The Norwegian Vitamin Trial; MTHFR, methylenetetrahydrofolate reductase.
NORVIT participants who took B vitamins and folic acid actually had a slight increase in risk despite a drop in homocysteine, suggesting "such therapy may be harmful" to people who have just suffered a heart attack, the research team wrote.
The NORVIT study enrolled 3,749 patients within 7 days after an MI.
Among NORVIT participants, self-reported current smokers were the largest group followed by ex-smokers and never smokers (46.4%, 32.6%, and 21.0%, respectively).
And the hint that folic acid takers in the NORVIT study had more cancers--though not statistically significant--wasn't reassuring either.
Bonaa was the principal investigator in NORVIT, a randomized, double-blind, multicenter trial in which 3,749 Norwegian patients were followed for 3.5 years after assignment to 0.8 mg/day of folic acid; 40 mg/day of vitamin [B.sub.6]; both; or placebo during their hospitalization for an acute MI.
Because of NORVIT's complex two-by-two factorial design, the study was underpowered to firmly conclude that B vitamin therapy was without benefit or indeed harmful.
The Norwegian Vitamin Trial (NORVIT) looked at whether high doses of B vitamins helped to prevent recurrent heart disease in patients who had already suffered a heart attack.
Coronary heart disease may respond differently to homocysteine-lowering therapy with B-vitamins, as indicated by 4 recent secondary intervention trials (VISP,HOPE2, NORVIT and CHAOS-2) that demonstrated no decreased risk (12).
Among the ongoing large-scale randomized trials (involving more than 1000 participants) that were initiated in Western countries, the results of 4 trials [Vitamin Intervention for Stroke Prevention (VISP) (18), the Norwegian Vitamin (NORVIT) trial (19), Heart Outcomes Prevention Evaluation-2 (HOPE-2) trial (20) and the Second Cambridge Heart Antioxidant Study (CHAOS-2)] have been published.
(36.) Bonaa KH, Njolstad I, Ueland PM, Schirmer H, Tverdal A, Steigen T, et al; NORVIT Trial investigators.