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Clinical Trials |

Beta Carotene Supplementation and Age-Related Maculopathy in a Randomized Trial of US Physicians

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. doi:10.1001/archopht.125.3.333.
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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: "http://clinicaltrials.gov/show/NCT00000152"

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Cumulative incidence rates of age-related maculopathy (ARM).

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Study design. Excluded were 929 participants who died during the first 7 years of the trial or who did not provide information about diagnoses of age-related maculopathy made during the first 7 years of the trial (requested on the 84-month questionnaire).

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