Antioxidant Vitamins and Aspirin for Cataract and AMD Prevention
This study aims to evaluate if antioxidant vitamins and aspirin can prevent the onset of cataracts and age-related macular degeneration (AMD) in adults.
Data Collection
Cataract+3
+ Eye Diseases
+ Lens Diseases
Prevention Study
Summary
Study start date: August 1, 1993
Actual date on which the first participant was enrolled.This study focuses on two common eye diseases, cataract and Age-related Macular Degeneration (AMD), which are significant causes of vision loss in older Americans. Cataract is a condition where the eye's lens becomes cloudy, affecting millions of people and requiring costly surgeries. AMD, on the other hand, is the leading cause of blindness in people aged 65 and older, with about 25% of this age group showing signs of the disease. Unfortunately, the causes of AMD are not fully understood, and there is no treatment available for most patients. As the U.S. population ages, the impact of these eye diseases on public health is expected to increase. The study involves two randomized, double-masked, placebo-controlled trials to test if supplementing with antioxidant vitamins and low-dose aspirin can reduce the risk of cataract and AMD. The participants are women from the Women's Health Study (WHS) and the Women's Antioxidant Cardiovascular Study (WACS). In these studies, some participants receive the supplements, while others receive a placebo. The WHS tests low-dose aspirin and vitamin E, while the WACS tests antioxidant vitamins (E, C, and beta carotene) and a combination of folate, vitamin B6, and B12. The study also examines various risk factors for these eye diseases, such as smoking, alcohol intake, blood pressure, and diet. The primary analysis will compare the occurrence of AMD or cataract in the treatment and placebo groups, using survival analysis to determine any difference in the time to diagnosis.
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.Female
Biological sex of participants that are eligible to enroll.Over 45 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
Women's Health Study: A participant must have met all of the following criteria: (a) female; (b) aged 45 years or older; (c) postmenopausal or with no intention of becoming pregnant; (d) no reported personal history of cardiovascular disease, cancer (other than non-melanoma skin cancer), gout, peptic ulcer, chronic renal or liver disease, or other serious illness precluding participation; (e) no reported history of serious side effects to the study treatments; (f) not currently taking aspirin, aspirin containing medication, or nonsteroidal anti-inflammatory drugs (NSAIDs) more than 1 day per week or, if so doing, willing to forego use of these medications; (g) not currently taking individual supplements of vitamin E or beta carotene more than 1 day per week; (h) not currently taking anticoagulants or corticosteroids. Women's Antioxidant Cardiovascular Study: Potentially eligible female health professionals for WACS were identified from the pool of respondents to the Women's Health Study initial mailing and must have met the following criteria: (a) female; (b) date of birth before January 1, 1955; (c) a reported history of myocardial infarction (MI), stroke (CVA), angina pectoris (AP), coronary artery bypass grafting (CABG), percutaneous transluminal angioplasty (PCTA), transient ischemic attack (TIA), carotid endarterectomy (CEA), or peripheral artery surgery (PAS); (d) no history of cancer (except non-melanoma skin cancer) within the past 10 years and no active liver disease or cirrhosis; (e) pregnancy physiologically impossible due to menopause (natural or surgical) or tubal ligation, or the participant does not intend to become pregnant in the future as indicated on the initial WHS questionnaire; (f) no current use of a vitamin K-depleting anticoagulant agent (e.g., Coumadin). Individuals taking aspirin or other NSAIDs were not excluded.