Vitamin E supplementation and macular degeneration: randomised controlled trial

Randomized controlled trial in healthy volunteers aged 55 to 80 years recruited at an urban study centre at Monash University. Participants underwent retinal imaging and eye examinations over 4 years to assess incident and progressive age-related macular degeneration.

Participants in the active arm received 500 IU daily of natural vitamin E (335 mg d-tocopherol) as an oral capsule in soybean oil suspension with gelatin for 4 years. The comparator received identical soybean oil placebo capsules.

Daily vitamin E did not prevent age-related macular degeneration or slow its progression. Four-year incidence of early AMD was 8.6% with vitamin E versus 8.1% with placebo (relative risk 1.05, 95% confidence interval 0.69 to 1.61), and late AMD incidence was 0.8% versus 0.6% (1.36, 0.67 to 2.77). Progression outcomes were also null or slightly worse with vitamin E, including side-by-side progression (RR 1.26, 1.01 to 1.57). Adverse events were broadly similar between groups, including capsule-related events in 15% versus 14% and ophthalmic adverse events in 18% versus 15%.

Single-centre study in generally healthy older adults, which limits generalizability to broader AMD populations. Follow-up was 4 years and event rates were low, especially for late AMD, reducing power for rarer outcomes. Some attrition and incomplete outcome ascertainment were present, with fewer participants analyzed or completing follow-up than were randomized.