Effects of B vitamins and omega 3 fatty acids on cardiovascular diseases: a randomised placebo controlled trialBMJ 2010; 341 doi: https://doi.org/10.1136/bmj.c6273 (Published 29 November 2010) Cite this as: BMJ 2010;341:c6273
- Pilar Galan, research director1,
- Emmanuelle Kesse-Guyot, research fellow1,
- Sébastien Czernichow, associate professor12,
- Serge Briancon, professor3,
- Jacques Blacher, professor14,
- Serge Hercberg, professor12
- for the SU.FOL.OM3 Collaborative Group
- 1UMR U557 Inserm; U1125 Inra; Cnam; Université Paris 13, CRNH IdF, F-93017 Bobigny, France
- 2Département de Santé publique, Hôpital Avicenne, 93017, F-Bobigny, France
- 3EA 4003, Ecole de Santé publique, Epidémiologie clinique, Faculté de Médecine, CHU Nancy, France
- 4Université Paris-Descartes, Faculté de Médecine; AP-HP; Hôtel-Dieu, Centre de Diagnostic et Thérapeutique, Paris, France
- Correspondence to: P Galan, U557 INSERM/INRA/CNAM/UP13, SMBH, 74, rue Marcel Cachin, 93017 Bobigny, France
- Accepted 16 September 2010
Objective To investigate whether dietary supplementation with B vitamins or omega 3 fatty acids, or both, could prevent major cardiovascular events in patients with a history of ischaemic heart disease or stroke.
Design Double blind, randomised, placebo controlled trial; factorial design.
Setting Recruitment throughout France via a network of 417 cardiologists, neurologists, and other physicians.
Participants 2501 patients with a history of myocardial infarction, unstable angina, or ischaemic stroke.
Intervention Daily dietary supplement containing 5-methyltetrahydrofolate (560 μg), vitamin B-6 (3 mg), and vitamin B-12 (20 μg) or placebo; and containing omega 3 fatty acids (600 mg of eicosapentanoic acid and docosahexaenoic acid at a ratio of 2:1) or placebo. Median duration of supplementation was 4.7 years.
Main outcome measures Major cardiovascular events, defined as a composite of non-fatal myocardial infarction, stroke, or death from cardiovascular disease.
Results Allocation to B vitamins lowered plasma homocysteine concentrations by 19% compared with placebo, but had no significant effects on major vascular events (75 v 82 patients, hazard ratio, 0.90 (95% confidence interval 0.66 to 1.23, P=0.50)). Allocation to omega 3 fatty acids increased plasma concentrations of omega 3 fatty acids by 37% compared with placebo, but also had no significant effect on major vascular events (81 v 76 patients, hazard ratio 1.08 (0.79 to 1.47, P=0.64)).
Conclusion This study does not support the routine use of dietary supplements containing B vitamins or omega 3 fatty acids for prevention of cardiovascular disease in people with a history of ischaemic heart disease or ischaemic stroke, at least when supplementation is introduced after the acute phase of the initial event.
Trial registration Current Controlled Trials ISRCTN41926726.
We thank Louise Mennen and Angelika De Bree, all the health professionals, and staff at the coordinating centre, and patients who participated in the SU.FOL.OM3 trial. We also acknowledge the expert help of Benoit Gautier for statistical analysis and Gwenael Monot for computer data management.
Contributors: PG, EK-G, SC, and SB had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the analysis. PG, SH, and SB were responsible for the study concept and design. PG, SH, JB, and the SU.FOL.OM3 Study Research Group acquired the data. All the authors participated in analysis and interpretation of the data. PG, SH, and EK-G drafted the manuscript. SC, JB, and SB critically revised the manuscript for important intellectual content. EK-G, PG, SH, and SB conducted the statistical analysis. SH and PG obtained funding. PG provided administrative, technical, and material support and supervised the study.
Funding: The SU.FOL.OM3 trial was supported by the French Ministry of Research (R02010JJ), Ministry of Health (DGS), Sodexo, Candia, Unilever, Danone, Roche Laboratory, Merck EPROVA GS, and Pierre Fabre Laboratory.
Competing interests: All authors have completed the Unified Competing Interest form at www.icmje.org/coi_disclosure.pdf and declare that they have no relationships with companies that might have an interest in the submitted work in the previous 3 years; they have no other relationships or activities that could appear to have influenced the submitted work.
Ethical approval: The study protocol was approved by the Consultation Committee for the Protection of Participants in Biomedical Research of the Paris-Cochin Hospital (CCPPRB No 1933) and the French National Information and Citizen Freedom Committee (CNIL No 901230).
Data sharing: No additional data available.
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