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William G. Christen, ScD; JoAnn E. Manson, MD, DrPH; Robert J. Glynn, ScD; J. Michael Gaziano, MD; Emily Y. Chew, MD; Julie E. Buring, ScD; Charles H. Hennekens, MD

Arch Ophthalmol. 2007;125(3):333-339.

Objective  To test whether beta carotene supplementation affects the incidence of age-related maculopathy (ARM) in a large-scale randomized trial.

Design  Randomized, double-masked, placebo-controlled trial among 22 071 apparently healthy US male physicians aged 40 to 84 years. Participants were randomly assigned to receive beta carotene (50 mg every other day) or placebo.

Main Outcome Measure  Incident ARM responsible for a reduction in best-corrected visual acuity to 20/30 or worse.

Results  After 12 years of treatment and follow-up, there were 162 cases of ARM in the beta carotene group vs 170 cases in the placebo group (relative risk [RR], 0.96; 95% confidence interval [CI], 0.78-1.20). The results were similar for the secondary end points of ARM with or without vision loss (275 vs 274 cases; RR, 1.01; 95% CI, 0.86-1.20) and advanced ARM (63 vs 66 cases; RR, 0.97; 95% CI, 0.69-1.37).

Conclusions  These randomized data relative to 12 years of treatment among a large population of apparently healthy men indicate that beta carotene supplementation has no beneficial or harmful effect on the incidence of ARM. Long-term supplemental use of beta carotene neither decreases nor increases the risk of ARM.

Trial Registration  clinicaltrials.gov Identifier: NCT00000152

Author Affiliations: Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital (Drs Christen, Manson, Glynn, Gaziano, and Buring), Departments of Epidemiology (Dr Manson) and Biostatistics (Dr Glynn), Harvard School of Public Health, and Department of Ambulatory Care and Prevention, Harvard Medical School (Dr Buring), Harvard University, and Massachusetts Veterans Epidemiology Research and Information Center, Department of Veterans Affairs Boston Healthcare System (Dr Gaziano), Boston; National Eye Institute, Bethesda, Md (Dr Chew); and Departments of Medicine and Epidemiology and Public Health, University of Miami School of Medicine, Miami, and Department of Biomedical Science, Center of Excellence in Biomedical and Marine Biotechnology, Florida Atlantic University, Boca Raton (Dr Hennekens).

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