Overview

Randomized Trial of Beta-Carotene and Macular Degeneration

Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
Male
Summary
To determine whether 50 mg of beta-carotene taken every other day reduces the risk of developing age-related macular degeneration (AMD) among male U.S. physicians who were aged 40 to 84 in 1982. To investigate the possible relationship of AMD with other antioxidants, including selenium and vitamins A, C, and E. To identify potential risk factors for development of AMD. Possible risk factors include height, systemic hypertension, cardiovascular disease, blood cholesterol, cigarette smoking, iris and skin color, sunlight exposure, body mass index, diabetes, and alcohol intake.
Phase:
Phase 3
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
National Eye Institute (NEI)
Treatments:
Aspirin
Beta Carotene
Carotenoids
Criteria
When the Physicians Health Study was established in the early 1980s by the NHLBI to collect
data on a stable population at risk for heart attack, only male physicians were studied
because males were thought to be at higher risk than females for ischemic heart problems.
The study population consists of 22,071 male U.S. physicians who were aged 40 to 84 years
in 1982. The subjects have no history of myocardial infarction, cancer, kidney disease,
renal disease, or any other contraindication to the use of aspirin or beta-carotene,
including regular use of corticosteroids.