VITamin D and OmegA-3 TriaL (VITAL): Fractures, Vitamin D and Genetic Markers
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 50 - Any |
| Updated: | 2/17/2019 |
| Start Date: | June 1, 2018 |
| End Date: | June 1, 2023 |
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
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
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.
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.
All participants in VITAL (NCT 01169259) are eligible to participate in this ancillary
study.
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