Randomized Trials of Vitamin Supplements and Eye Disease

Phase 3 Unknown National Eye Institute (NEI)

RandomizedFactorialDouble-blindPrevention

Summary

To determine whether vitamin E supplementation reduces the risk of cataract and age-related macular degeneration (AMD) in women. To determine whether vitamin C supplementation reduces the risk of cataract and AMD in women. To determine whether beta-carotene supplementation reduces the risk of cataract and AMD in women. To determine whether alternate day, low-dose aspirin reduces the risk of cataract and AMD in women. To identify potential risk factors for cataract and AMD including cigarette smoking, alcohol intake, blood pressure, blood cholesterol, cardiovascular disease, height, body mass index, and diabetes.

Timeline

Start: 1993-08
Primary completion: —
Completion: —

Outcome

Met primary endpoint

paper 55 cases of AMD in the combination treatment group and 82 in the placebo group (relative risk, 0.66; 95% confidence interval, 0.47-0.93 [P = .02]). PMID 19237716 ↗

paper For visually significant AMD, there were 26 cases in the combination treatment group and 44 in the placebo group (relative risk, 0.59; 95% confidence interval, 0.36-0.95 [P = .03]). PMID 19237716 ↗

Publications

Christen WG, Glynn RJ, Chew EY, Albert CM, Manson JE. Folic acid, pyridoxine, and cyanocobalamin combination treatment and age-related macular degeneration in women: the Women's Antioxidant and Folic Acid Cardiovascular Study. Arch Intern Med. 2009 Feb 23;169(4):335-41. doi: 10.1001/archinternmed.2008.574.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Aspirin	Small molecule	100 mg	—
Subject	Vitamin C	Other / unclassified	500 mg	—
Subject	Vitamin E	Other / unclassified	600 iu	—
Subject	beta-carotene	Small molecule	50 mg	—