Beta-Carotene and Macular Degeneration Prevention Study
Data Collection
Eye Diseases+1
+ Macular Degeneration
+ Retinal Degeneration
Prevention Study
Summary
Study start date: April 1, 1982
Actual date on which the first participant was enrolled.Macular degeneration is a leading cause of blindness, especially in people aged 65 and older in the United States. This condition affects over 100,000 people each year, with no known prevention methods or treatments for most patients. The cause of macular degeneration remains unclear, but research suggests that antioxidants like beta-carotene might play a protective role. This study is part of the Physicians Health Study, sponsored by the National Heart, Lung, and Blood Institute, and focuses on exploring the potential of beta-carotene in preventing macular degeneration. The trial involves over 22,000 physicians who are randomly assigned to take either beta-carotene or a placebo. In this trial, participants take one 50-mg beta-carotene capsule every other day. The study measures the effectiveness of beta-carotene by comparing the occurrence of macular degeneration between the group taking beta-carotene and the group taking a placebo. Any reported diagnoses of macular degeneration are confirmed through medical record reviews. The Cox proportional hazards model is used to determine whether there is a difference in time to diagnosis of macular degeneration between the two groups. This study aims to shed light on the potential protective role of beta-carotene in preventing macular degeneration and to identify any additional risk factors.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Male
Biological sex of participants that are eligible to enroll.From 40 to 84 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.