Document Detail

Effects of B vitamins and omega 3 fatty acids on cardiovascular diseases: a randomised placebo controlled trial.
MedLine Citation:
PMID:  21115589     Owner:  NLM     Status:  MEDLINE    
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.
Pilar Galan; Emmanuelle Kesse-Guyot; Sébastien Czernichow; Serge Briancon; Jacques Blacher; Serge Hercberg;
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2010-11-29
Journal Detail:
Title:  BMJ (Clinical research ed.)     Volume:  341     ISSN:  1756-1833     ISO Abbreviation:  BMJ     Publication Date:  2010  
Date Detail:
Created Date:  2010-11-30     Completed Date:  2010-12-13     Revised Date:  2013-07-03    
Medline Journal Info:
Nlm Unique ID:  8900488     Medline TA:  BMJ     Country:  England    
Other Details:
Languages:  eng     Pagination:  c6273     Citation Subset:  AIM; IM    
UMR U557 Inserm, U1125 Inra, Cnam, Université Paris 13, CRNH IdF, F-93017 Bobigny, France.
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MeSH Terms
Aged, 80 and over
Angina, Unstable / diet therapy
Biological Markers / blood
Cardiovascular Diseases / prevention & control*
Dietary Supplements
Double-Blind Method
Fatty Acids, Omega-6 / administration & dosage*,  blood
Kaplan-Meier Estimate
Middle Aged
Myocardial Infarction / diet therapy
Patient Compliance
Stroke / diet therapy
Treatment Outcome
Vitamin B Complex / administration & dosage*,  blood
Reg. No./Substance:
0/Biological Markers; 0/Fatty Acids, Omega-6; 12001-76-2/Vitamin B Complex

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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