Effects of Vitamin D and Omega-3 Fatty Acids on Infectious Diseases and hCAP18
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 25,874
- 试验地点
- 1
- 主要终点
- upper respiratory infection
研究概览
简要总结
The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is an ongoing 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 affect risk of infection and plasma hCAP18 levels.
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
- Quadruple (Participant, Care Provider, 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
vitamin D + fish oil
vitamin D3 + Omacor
干预措施: vitamin D3 (Dietary Supplement)
vitamin D + fish oil
vitamin D3 + Omacor
干预措施: omega-3 fatty acids (fish oil) (Drug)
vitamin D + fish oil placebo
vitamin D3 + fish oil placebo
干预措施: vitamin D3 (Dietary Supplement)
vitamin D + fish oil placebo
vitamin D3 + fish oil placebo
干预措施: fish oil placebo (Dietary Supplement)
vitamin D placebo + fish oil
vitamin D placebo + Omacor
干预措施: omega-3 fatty acids (fish oil) (Drug)
vitamin D placebo + fish oil
vitamin D placebo + Omacor
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)
结局指标
主要结局
upper respiratory infection
时间窗: one year
hCAP-18
时间窗: one year
次要结局
- lower respiratory infection(5 years)
- urinary tract infection(5 years)
- cellulitis(5 years)
- antimicrobial-treated infection(5 years)
- infection-related hospitalizations(5 years)
研究者
Carlos A. Camargo
Professor of Medicine
Brigham and Women's Hospital