VITamin D and OmegA-3 TriaL: Effects on Bone Structure and Architecture
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 771
- 试验地点
- 1
- 主要终点
- Bone Turnover Beta Crosslaps
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 fish oil (1 gram of omega-3 fatty acids) 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 a sub-cohort of 771 participants in VITAL and will test the efficacy and safety of high-dose vitamin D supplementation vs. placebo on skeletal health and body composition.
详细描述
The VITAL: Effects on Bone Structure and Architecture is an ancillary study of the parent VITAL. This study has enrolled a sub-cohort of 771 VITAL participants at the NIH-sponsored Harvard Catalyst Clinical and Translational Science Center (CTSC). The following measurements will be performed at baseline and 2 years post-randomization to determine whether high-dose vitamin D supplementation vs. placebo: 1) produces small increases or reduces bone loss in spine, hip, and total body areal bone density as assessed by dual x-ray absorptiometry (DXA); 2) reduces bone turnover as assessed by biomarkers of bone resorption and formation; 3) improves (a) volumetric bone mineral density (vBMD) and measures of bone structure as assessed by peripheral quantitative computed tomography (pQCT) and (b) bone microarchitecture as assessed by high resolution pQCT (HR-pQCT) at the distal radius and tibia as well as trabecular bone score (TBS) at the spine; and 4) results in changes in body composition as assessed by DXA. Parallel assessments of the effects of omega-3 fatty acids will be performed. This study may elucidate the mechanisms through which high-dose vitamin D may prevent age-related fractures and provide new insights into the role of vitamin D on skeletal health and body composition.
We are currently analyzing the effects of daily dietary supplements of fish oil (1 gram of omega-3 fatty acids) vs. placebo on skeletal health and body composition.
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
- •Participants in VITAL (NCT 01169259) who meet the following criteria are eligible to participate in this ancillary study:
- •Those who are using bisphosphonates currently or within the past 2 years, or other bone-active medications currently or within the past year are not eligible for this study.
排除标准
- 未提供
研究组 & 干预措施
Vitamin D placebo + fish oil placebo
Daily vitamin D placebo and daily fish oil placebo
干预措施: Fish oil placebo (Dietary Supplement)
Vitamin D placebo + fish oil
Daily vitamin D placebo and daily fish oil capsule (1 g/d; EPA + DHA in a 1.2:1 ratio)
干预措施: Vitamin D3 placebo (Dietary Supplement)
Vitamin D placebo + fish oil
Daily vitamin D placebo and daily fish oil capsule (1 g/d; EPA + DHA in a 1.2:1 ratio)
干预措施: omega-3 fatty acids (fish oil) (Dietary Supplement)
Vitamin D + fish oil placebo
Daily vitamin D (2,000 IU/d) and daily fish oil placebo
干预措施: Fish oil placebo (Dietary Supplement)
Vitamin D + fish oil placebo
Daily vitamin D (2,000 IU/d) and daily fish oil placebo
干预措施: Vitamin D3 (Dietary Supplement)
Vitamin D + fish oil
Daily vitamin D (2,000 IU/d) and daily fish oil capsule (1 g/d; EPA + DHA in a 1.2:1 ratio)
干预措施: omega-3 fatty acids (fish oil) (Dietary Supplement)
Vitamin D + fish oil
Daily vitamin D (2,000 IU/d) and daily fish oil capsule (1 g/d; EPA + DHA in a 1.2:1 ratio)
干预措施: Vitamin D3 (Dietary Supplement)
Vitamin D placebo + fish oil placebo
Daily vitamin D placebo and daily fish oil placebo
干预措施: Vitamin D3 placebo (Dietary Supplement)
结局指标
主要结局
Bone Turnover Beta Crosslaps
时间窗: 2 years
To determine whether vitamin D and/or omega-3 supplementation reduces bone turnover, assessed biomarkers of bone resorption (beta crosslaps).
Bone Turnover P1NP
时间窗: 2 years
To determine whether vitamin D and/or omega-3 supplementation reduces bone turnover, assessed biomarkers of bone formation (propeptide of type 1 collagen \[P1NP\]).
Change in Bone Density
时间窗: 2 years
To determine whether vitamin D and/or omega-3 supplementation produces small increases or reduces bone loss in spine, hip, and total body areal bone density, as assessed by DXA. Reported values are rounded up.
次要结局
- Change in Bone Structure(2 years)
研究者
Meryl LeBoff
Director of Skeletal Health and Osteoporosis Center
Brigham and Women's Hospital
