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临床试验/NCT01747447
NCT01747447已完成不适用

VITamin D and OmegA-3 TriaL: Effects on Bone Structure and Architecture

Brigham and Women's Hospital1 个研究点 分布在 1 个国家目标入组 771 人开始时间: 2012年8月1日最近更新:
适应症
干预措施

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

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

Placebo Comparator

Daily vitamin D placebo and daily fish oil placebo

干预措施: Fish oil placebo (Dietary Supplement)

Vitamin D placebo + fish oil

Active Comparator

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

Active Comparator

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

Active Comparator

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

Active Comparator

Daily vitamin D (2,000 IU/d) and daily fish oil placebo

干预措施: Vitamin D3 (Dietary Supplement)

Vitamin D + fish oil

Active Comparator

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

Active Comparator

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

Placebo Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Meryl LeBoff

Director of Skeletal Health and Osteoporosis Center

Brigham and Women's Hospital

研究点 (1)

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