Effects of B vitamins and omega 3 fatty acids on cardiovascular diseases: a randomised placebo controlled trial.
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.


METHODS
Double blind, randomised, placebo controlled trial; factorial design.


METHODS
Recruitment throughout France via a network of 417 cardiologists, neurologists, and other physicians.


METHODS
2501 patients with a history of myocardial infarction, unstable angina, or ischaemic stroke.


METHODS
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.


METHODS
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)).


CONCLUSIONS
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.


BACKGROUND
Current Controlled Trials ISRCTN41926726.
UMR U557 Inserm, U1125 Inra, Cnam, Université Paris 13, CRNH IdF, F-93017 Bobigny, France. p.galan@uren.smbh.univ-paris13.fr
Pilar
P
Galan
Emmanuelle
E
Kesse-Guyot
Sébastien
S
Czernichow
Serge
S
Briancon
Jacques
J
Blacher
Serge
S
Hercberg
D000368:Aged; D000369:Aged, 80 and over; D000789:Angina, Unstable / Q000178:diet therapy; D015415:Biomarkers / Q000097:blood; D002318:Cardiovascular Diseases / Q000517:prevention & control*; D019587:Dietary Supplements; D004311:Double-Blind Method; D043371:Fatty Acids, Omega-6 / Q000008:administration & dosage* / Q000097:blood; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000178:diet therapy; D010349:Patient Compliance; D020521:Stroke / Q000178:diet therapy; D016896:Treatment Outcome; D014803:Vitamin B Complex / Q000008:administration & dosage* / Q000097:blood
D015415:Biomarkers; D043371:Fatty Acids, Omega-6; D014803:Vitamin B Complex