VITamin D and OmegA-3 TriaL (VITAL): Fractures, Vitamin D and Genetic Markers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25,871
- 试验地点
- 1
- 主要终点
- Incident total, non-vertebral, and hip fractures
研究概览
简要总结
The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is a randomized clinical trial in 25,871 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 (1) whether vitamin D reduces incident total, non-vertebral fractures, and hip fractures and (2) whether this reduction is modified by vitamin D levels
详细描述
The VITAL: Vitamin D, Fractures, and Genetic Markers is an ancillary study of the parent VITAL trial (VITamin D and OmegA-3 TriaL). The study will require the adjudication of all self-reported incident fracture events among 25,871 men and women. Findings from this ancillary study will inform clinical practice on the role(s) of vitamin D supplements in fracture prevention. This proposal will generate important positive or informative negative results about effects of supplemental vitamin D3 alone on fracture risk, while also elucidating the relative importance of vitamin D biomarkers and genetic variations in vitamin D-related pathways on bone. Findings from the proposed ancillary study have the potential for major clinical as well as public health impact for both men and women in the U.S.
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)
盲法说明
Double Blind
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 from the VITAL parent study (NCT01169259) were enrolled in this ancillary study.
排除标准
- 未提供
研究组 & 干预措施
Vitamin D placebo + fish oil
干预措施: omega-3 fatty acids (fish oil) (Drug)
Vitamin D + fish oil
干预措施: omega-3 fatty acids (fish oil) (Drug)
Vitamin D placebo + fish oil placebo
干预措施: Fish oil placebo (Dietary Supplement)
Vitamin D placebo + fish oil placebo
干预措施: Vitamin D3 placebo (Dietary Supplement)
Vitamin D placebo + fish oil
干预措施: Vitamin D3 placebo (Dietary Supplement)
Vitamin D + fish oil placebo
干预措施: Fish oil placebo (Dietary Supplement)
Vitamin D + fish oil
干预措施: Vitamin D3 (Dietary Supplement)
Vitamin D + fish oil placebo
干预措施: Vitamin D3 (Dietary Supplement)
结局指标
主要结局
Incident total, non-vertebral, and hip fractures
时间窗: 5 years
To determine whether vitamin D supplementation will reduce incident total, non-vertebral, and hip fractures according to annual questionnaires, medical record review, and fracture adjudication.
次要结局
- Incident total, non-vertebral, and hip fractures(5 years)
研究者
Meryl LeBoff
Director of Skeletal Health and Osteoporosis Center
Brigham and Women's Hospital