Body Composition Clinical Trial
— VITALOfficial title:
VITamin D and OmegA-3 TriaL: Effects on Bone Structure and Architecture
Verified date | May 2024 |
Source | Brigham and Women's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 771 |
Est. completion date | June 2024 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 50 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Brigham and Women's Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Brigham and Women's Hospital | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
United States,
Donlon CM, LeBoff MS, Chou SH, Cook NR, Copeland T, Buring JE, Bubes V, Kotler G, Manson JE. Baseline characteristics of participants in the VITamin D and OmegA-3 TriaL (VITAL): Effects on Bone Structure and Architecture. Contemp Clin Trials. 2018 Apr;67:56-67. doi: 10.1016/j.cct.2018.02.003. Epub 2018 Feb 23. — View Citation
Goldman AL, Donlon CM, Cook NR, Manson JE, Buring JE, Copeland T, Yu CY, LeBoff MS. VITamin D and OmegA-3 TriaL (VITAL) bone health ancillary study: clinical factors associated with trabecular bone score in women and men. Osteoporos Int. 2018 Nov;29(11):2505-2515. doi: 10.1007/s00198-018-4633-3. Epub 2018 Jul 18. — View Citation
LeBoff MS, Chou SH, Murata EM, Donlon CM, Cook NR, Mora S, Lee IM, Kotler G, Bubes V, Buring JE, Manson JE. Effects of Supplemental Vitamin D on Bone Health Outcomes in Women and Men in the VITamin D and OmegA-3 TriaL (VITAL). J Bone Miner Res. 2020 May;35(5):883-893. doi: 10.1002/jbmr.3958. Epub 2020 Jan 30. — View Citation
LeBoff MS, Yue AY, Copeland T, Cook NR, Buring JE, Manson JE. VITAL-Bone Health: rationale and design of two ancillary studies evaluating the effects of vitamin D and/or omega-3 fatty acid supplements on incident fractures and bone health outcomes in the VITamin D and OmegA-3 TriaL (VITAL). Contemp Clin Trials. 2015 Mar;41:259-68. doi: 10.1016/j.cct.2015.01.007. Epub 2015 Jan 24. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Body Composition | To determine whether vitamin D and/or omega-3 supplementation results in changes in body composition as assessed by DXA: total body fat and lean mass, and fat mass index and lean mass index, regional fat and lean mass and derived ratios. | 2 years | |
Primary | Change in Bone Density | 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. | 2 years | |
Primary | Bone Turnover P1NP | To determine whether vitamin D and/or omega-3 supplementation reduces bone turnover, assessed biomarkers of bone formation (propeptide of type 1 collagen [P1NP]). | 2 years | |
Primary | Bone Turnover Beta Crosslaps | To determine whether vitamin D and/or omega-3 supplementation reduces bone turnover, assessed biomarkers of bone resorption (beta crosslaps). | 2 years | |
Secondary | Change in Bone Structure | To determine whether vitamin D and/or omega-3 supplementation results in changes in bone structure. | 2 years |
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