Vitamin E supplementation and macular degeneration: randomised controlled trial.

OBJECTIVE To determine whether vitamin E supplementation influences the incidence or rate of progression of age related maculopathy (AMD). DESIGN Prospective randomised placebo controlled clinical trial. SETTING An urban study centre in a residential area supervised by university research staff. PARTICIPANTS 1193 healthy volunteers aged between 55 and 80 years; 73% completed the trial on full protocol. INTERVENTIONS Vitamin E 500 IU or placebo daily for four years. MAIN OUTCOME MEASURES PRIMARY OUTCOME development of early age related macular degeneration in retinal photographs. Other measures included alternative definitions of age related macular degeneration, progression, changes in component features, visual acuity, and visual function RESULTS The incidence of early age related macular degeneration (early AMD 3) was 8.6% in those receiving vitamin E versus 8.1% in those on placebo (relative risk 1.05, 95% confidence interval 0.69 to 1.61). For late disease the incidence was 0.8% versus 0.6% (1.36, 0.67 to 2.77). Further analysis showed no consistent differences in secondary outcomes. CONCLUSION Daily supplement with vitamin E supplement does not prevent the development or progression of early or later stages of age related macular degeneration.