Age-related Macular Degeneration (AMD) in the Vitamin D and Omega-3 Trial (VITAL)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 25,871
- 试验地点
- 1
- 主要终点
- Number of Participants With an AMD Event
研究概览
简要总结
The VITamin D and OmegA-3 Trial (VITAL; NCT 01169259) is a randomized clinical trial in 25,875 U.S. men and women investigating whether taking daily dietary supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor fish oil, 1 gram) reduces the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses. This ancillary study is being conducted among participants in VITAL and will examine whether vitamin D or omega-3 fatty acids, compared to placebo, reduce the incidence and/or progression of age-related macular degeneration (AMD).
详细描述
This ancillary study to the VITamin D and OmegA-3 TriaL (VITAL) will examine whether vitamin D3 and omega-3 fatty acids can help prevent the onset or progression of age-related macular degeneration (AMD). The study will also examine whether vitamin D3 and omega-3 fatty acids interact with each other, or with specific genes associated with AMD or vitamin D3 or omega-3 fatty acid metabolic activity, to affect the risk of developing AMD.
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
- All
- 接受健康志愿者
- 是
入选标准
- •All participants in VITAL (NCT 01169259) are eligible to participate in this ancillary study.
排除标准
- 未提供
研究组 & 干预措施
Vitamin D + fish oil placebo
Vitamin D3 (cholecalciferol), 2000 IU per day
Fish oil placebo
干预措施: Vitamin D3 (Dietary Supplement)
Vitamin D + fish oil placebo
Vitamin D3 (cholecalciferol), 2000 IU per day
Fish oil placebo
干预措施: Fish oil placebo (Dietary Supplement)
Vitamin D placebo + fish oil
Vitamin D placebo
Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg. of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA])
干预措施: Omega-3 fatty acids (fish oil) (Drug)
Vitamin D placebo + fish oil
Vitamin D placebo
Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg. of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA])
干预措施: Vitamin D3 placebo (Dietary Supplement)
Vitamin D placebo + fish oil placebo
Vitamin D placebo
fish oil placebo
干预措施: Vitamin D3 placebo (Dietary Supplement)
Vitamin D placebo + fish oil placebo
Vitamin D placebo
fish oil placebo
干预措施: Fish oil placebo (Dietary Supplement)
Vitamin D + fish oil
Vitamin D (cholecalciferol), 2000 IU per day
Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg. of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA])
干预措施: Omega-3 fatty acids (fish oil) (Drug)
Vitamin D + fish oil
Vitamin D (cholecalciferol), 2000 IU per day
Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg. of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA])
干预措施: Vitamin D3 (Dietary Supplement)
结局指标
主要结局
Number of Participants With an AMD Event
时间窗: 5 years
AMD Event = a composite endpoint of incident AMD plus cases of progression to advanced AMD among participants with AMD at baseline
次要结局
- Number of Participants With Incident Visually-Significant AMD(5 years)
- Number of Participants With Incident Advanced AMD(5 years)
研究者
William G. Christen
Associate Professor
Brigham and Women's Hospital