B vitamin and/or n-3 fatty acid supplementation and health-related quality of life: ancillary findings from the SU.FOL.OM3 randomized trial.
BACKGROUND
Despite growing attention to nutrition and quality of life in cardiovascular disease survivors, the impact of dietary factors according to disease type or to quality of life domain is poorly understood. We investigated the effects of B vitamin and/or n-3 fatty acid supplementation on health-related quality of life among survivors of stroke, myocardial infarction, or unstable angina.


METHODS
We performed ancillary analyses of the SU.FOL.OM3 trial (2003-2009; France). In total, 2,501 men (mean age = 61 y) and women (mean age = 63 y) were randomized in a 2×2 factorial design to: 1) 0.56 mg 5-methyl-tetrahydrofolate, 3 mg vitamin B6, 0.02 mg vitamin B12; 2) 600 mg eicosapentaenoic and docosahexaenoic acids in a 2∶1 ratio; 3) B vitamins and n-3 fatty acids combined; or 4) placebo. Health-related quality of life was evaluated at follow-up with the Medical Outcomes Study 36-Item Short Form Health Survey. Data from 2,029 individuals were used in this analysis.


RESULTS
After 3.1±0.4 y, no effects of supplementation with either B vitamins or n-3 fatty acids on quality of life (physical or mental health domains) were found. However, participants receiving B vitamins had slightly more activity limitations due to emotional problems compared with those not receiving B vitamins (mean difference = 3.8; 95% CI: 0.4, 7.1). A significant interaction of treatment by prior disease revealed an inverse association between n-3 fatty acids and vitality among myocardial infarction survivors (mean difference = 2.9; 95% CI: 0.5, 5.2).


CONCLUSIONS
There were no beneficial effects of supplementation with relatively low doses of B vitamins or n-3 fatty acids on health-related quality of life in cardiovascular disease survivors. The adverse effects of B vitamins on activity limitations and of n-3 fatty acids on vitality among individuals with prior myocardial infarction merit confirmation.
Nutritional Epidemiology Research Unit, Sorbonne-Paris-Cité, University of Paris XIII, French Institute of Health and Medical Research, National Institute of Agronomic Research, National Conservatory of Arts and Crafts, Bobigny, France.
Valentina A
VA
Andreeva
University Hospital Center, Department of Clinical Epidemiology and Evaluation, Nancy, France ; Université de Lorraine, Université Paris Descartes, Nancy, France.
Clotilde
C
Latarche
Nutritional Epidemiology Research Unit, Sorbonne-Paris-Cité, University of Paris XIII, French Institute of Health and Medical Research, National Institute of Agronomic Research, National Conservatory of Arts and Crafts, Bobigny, France ; Department of Public Health, Avicenne Hospital, Bobigny, France.
Serge
S
Hercberg
University Hospital Center, Department of Clinical Epidemiology and Evaluation, Nancy, France ; Université de Lorraine, Université Paris Descartes, Nancy, France.
Serge
S
Briançon
Nutritional Epidemiology Research Unit, Sorbonne-Paris-Cité, University of Paris XIII, French Institute of Health and Medical Research, National Institute of Agronomic Research, National Conservatory of Arts and Crafts, Bobigny, France.
Pilar
P
Galan
Nutritional Epidemiology Research Unit, Sorbonne-Paris-Cité, University of Paris XIII, French Institute of Health and Medical Research, National Institute of Agronomic Research, National Conservatory of Arts and Crafts, Bobigny, France.
Emmanuelle
E
Kesse-Guyot
D019587:Dietary Supplements; D015525:Fatty Acids, Omega-3 / Q000494:pharmacology*; D005260:Female; D005492:Folic Acid / Q000008:administration & dosage / Q000494:pharmacology; D005500:Follow-Up Studies; D006262:Health; D006801:Humans; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D011795:Surveys and Questionnaires; D014805:Vitamin B 12 / Q000008:administration & dosage / Q000494:pharmacology*; D025101:Vitamin B 6 / Q000008:administration & dosage / Q000494:pharmacology*
D015525:Fatty Acids, Omega-3; D025101:Vitamin B 6; D005492:Folic Acid; D014805:Vitamin B 12