Physicians' Health Study II
- Conditions
- Prostate CancerEye DiseaseCognitive DeclineCancerColorectal CancerCardiovascular Disease
- Interventions
- Dietary Supplement: Vitamin EDietary Supplement: Vitamin CDietary Supplement: MultivitaminDietary Supplement: Beta-carotene
- Registration Number
- NCT00270647
- Lead Sponsor
- Brigham and Women's Hospital
- Brief Summary
The use of vitamin E, vitamin C, beta carotene, and/or multivitamins may keep cancer, cardiovascular disease, eye diseases, or cognitive decline from occurring. This randomized clinical trial studied vitamin E, vitamin C, beta carotene, and/or multivitamins to see how well they work compared with placebos in preventing cancer, cardiovascular disease, eye disease, and cognitive decline in male doctors aged 50 years and older.
- Detailed Description
OBJECTIVES:
Primary
* To determine whether vitamin E every other day reduces the risk of developing prostate cancer in older healthy male physicians.
* To determine whether daily vitamin C and/or a multivitamin reduces the risk of total cancer in these participants.
* To determine whether vitamin E every other day, vitamin C daily, or a multivitamin daily reduces the risk of major cardiovascular events in these participants.
Secondary
* To determine whether vitamin E and/or multivitamins reduce the risk of developing total cancer, colon cancer, and colon polyps in these participants.
* To determine whether vitamin E, vitamin C, or multivitamins reduce the risk of myocardial infarction and stroke in these participants.
* To determine whether vitamin E, vitamin C, or multivitamins reduce the risk of age-related macular degeneration or cataract in these participants.
* To determine whether vitamin E, vitamin C, or multivitamins reduce the risk of early cognitive decline in participants aged 65 and over.
The Physicians' Health Study II was a randomized, double-blind, placebo-controlled, factorial trial that began in 1997 and ended in 2011. It was designed to test four supplements -- (1) alternate-day vitamin E (400 international units of synthetic alpha-tocopherol) or its placebo; (2) daily vitamin C (500 mg synthetic ascorbic acid) or its placebo; (3) a daily multivitamin (Centrum Silver) or its placebo; and (4) alternate-day beta carotene (50 mg Lurotin) or its placebo -- in the prevention of cancer, cardiovascular disease, eye disease, and early cognitive decline among 14,641 male physicians aged 50 years or older. Participants were randomly assigned in a 2x2x2x2 factorial trial to receive combinations of the four active supplements or their placebos. Pills and/or packaging were provided by BASF Corporation, Pfizer (formerly Wyeth, American Home Products, and Lederle), and DSM Nutritional Products (formerly Roche Vitamins).
The beta-carotene component was discontinued on March 8, 2003; the vitamin E and vitamin C components ended as scheduled on August 31, 2007; and the multivitamin component ended on June 1, 2011.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 14641
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Vitamin E Vitamin E Active or placebo vitamin E Vitamin C Vitamin C Active or placebo vitamin C Multivitamin Multivitamin Active or placebo multivitamin Beta-carotene Beta-carotene Active or placebo beta-carotene
- Primary Outcome Measures
Name Time Method Prostate cancer Ongoing Total cancer Ongoing Major cardiovascular events Ongoing
- Secondary Outcome Measures
Name Time Method Cataract Ongoing Age-related macular degeneration Ongoing Early cognitive decline Ongoing Myocardial infarction Ongoing Stroke Ongoing Colorectal cancer Ongoing