Physicians' Health Study II: Trial of Vitamins in the Chemoprevention of Cancer, CVD, and Eye Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14,641
- 主要终点
- Prostate cancer
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Vitamin C
Active or placebo vitamin C
干预措施: Vitamin C (Dietary Supplement)
Vitamin E
Active or placebo vitamin E
干预措施: Vitamin E (Dietary Supplement)
Beta-carotene
Active or placebo beta-carotene
干预措施: Beta-carotene (Dietary Supplement)
Multivitamin
Active or placebo multivitamin
干预措施: Multivitamin (Dietary Supplement)
结局指标
主要结局
Prostate cancer
时间窗: Ongoing
Total cancer
时间窗: Ongoing
Major cardiovascular events
时间窗: Ongoing
次要结局
- Cataract(Ongoing)
- Age-related macular degeneration(Ongoing)
- Early cognitive decline(Ongoing)
- Myocardial infarction(Ongoing)
- Stroke(Ongoing)
- Colorectal cancer(Ongoing)
研究者
John Michael Gaziano, MD
Physician, Brigham and Women's Hospital; Professor of Medicine, Harvard Medical School
Brigham and Women's Hospital