VITamin D and OmegA-3 TriaL: Effects on Bone Structure and Architecture
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Orthopedic, Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 50 - Any |
| Updated: | 2/13/2019 |
| Start Date: | August 2012 |
| End Date: | September 2019 |
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.
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.
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.
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.
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.
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