Effects of Multivitamin Supplement on Cataract and Age-Related Macular Degeneration in a Randomized Trial of Male Physicians
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Figure 1
Flow diagram of the multivitamin component of the Physicians' Health Study II. A total of 3144 participants who reported a diagnosis of cataract at baseline and 408 participants who reported a diagnosis of age-related macular degeneration (AMD) at baseline were excluded.
Figure 2
Cumulative incidence rates of cataract in the multivitamin and placebo groups in the Physicians' Health Study II. Y = year.
Figure 3
Cumulative incidence rates of age-related macular degeneration (AMD) in the multivitamin and placebo groups in the Physicians' Health Study II. Y = year.
Purpose
To test whether long-term multivitamin supplementation affects the incidence of cataract or age-related macular degeneration (AMD) in a large cohort of men.
Design
Randomized, double-blind, placebo-controlled trial.
Participants
A total of 14 641 US male physicians aged ≥50 years.
Intervention
Daily multivitamin or placebo.
Main Outcome Measures
Incident cataract and visually significant AMD responsible for a reduction in best-corrected visual acuity to 20/30 or worse based on self-reports confirmed by medical record review.
Results
During an average of 11.2 years of treatment and follow-up, a total of 1817 cases of cataract and 281 cases of visually significant AMD were confirmed. There were 872 cataracts in the multivitamin group and 945 cataracts in the placebo group (hazard ratio [HR], 0.91; 95% confidence interval [CI], 0.83–0.99; P = 0.04). For visually significant AMD, there were 152 cases in the multivitamin group and 129 cases in the placebo group (HR, 1.19; 95% CI, 0.94–1.50; P = 0.15).
Conclusions
These randomized trial data from a large cohort of middle-aged and older US male physicians indicate that long-term daily multivitamin use modestly and significantly decreased the risk of cataract but had no significant effect on visually significant AMD.
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Financial Disclosure(s): The author(s) have made the following disclosure(s): W.G.C. received research funding support from the National Institutes of Health and DSM Nutritional Products Inc. (formerly Roche Vitamins). R.J.G. received investigator-initiated research funding from the National Institutes of Health, Bristol-Meyers Squibb, AstraZeneca, and Novartis, and signed a consulting agreement with Merck to give an invited talk. J.E.M. received investigator-initiated research funding from the National Institutes of Health and assistance with study pills and packaging from BASF and Cognis Corporations for the WAFACS and from Pronova BioPharma and Pharmavite for the VITamin D and OmegA-3 TriaL, and funding from the nonprofit Aurora Foundation. J.E.B. received investigator-initiated research funding from the National Institutes of Health and assistance with study pills and packaging from Natural Source Vitamin E Association and Bayer Healthcare for the Women's Health Study. H.D.S. received investigator-initiated research funding from the National Institutes of Health, the Tomato Products Wellness Council, and Cambridge Theranostics, Ltd. J.M.G. received investigator-initiated research funding from the National Institutes of Health, the Veterans Administration, and the BASF Corporation; assistance with study agents and packaging from BASF Corporation and Pfizer Inc. (formerly Wyeth, American Home Products, and Lederle); and assistance with study packaging provided by D.S.M. Nutritional Products Inc. (formerly Roche Vitamins). No other authors reported financial disclosures.
Supported by Grants CA 097193 (which included funding from the National Eye Institute and the National Institute on Aging), CA 34944 , CA 40360 , HL 26490 , and HL 34595 from the National Institutes of Health (Bethesda, MD), and an investigator-initiated grant from BASF Corporation (Florham Park, NJ). Study agents and packaging were provided by BASF Corporation and Pfizer Inc. (formerly Wyeth, American Home Products, and Lederle) (New York, NY), and study packaging was provided by DSM Nutritional Products, Inc. (formerly Roche Vitamins) (Parsippany, NJ). The National Institutes of Health, BASF, Pfizer Inc., and DSM Nutritional Products Inc., had no role in the study design; conduct of the study; collection, management, analysis, and interpretation of the data; or preparation, review, or approval of the manuscript.
Trial registration: clinicaltrials.gov identifier: NCT00270647
