N/A
Completed N=771
VITamin D and OmegA-3 TriaL: Effects on Bone Structure and Architecture (VITAL)
Bone Density · Body Composition · Bone Health
Source: ClinicalTrials.gov NCT01747447 ↗
Enrolled (actual)
771
Serious AEs
9.9%
Results posted
Mar 2021
Primary outcomePrimary: Change in Bone Density — 1.02; 1.02; 1.02; 1.02 g/cm^2
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Bone Density |
1.02; 1.02; 1.02; 1.02; 1.03; 1.03 | — |
| PRIMARY Bone Turnover P1NP |
49.99; 49.29; 50.25; 48.99; 48.28; 49.04 | — |
| PRIMARY Bone Turnover Beta Crosslaps |
0.40; 0.41; 0.41; 0.40; 0.40; 0.42 | — |
| SECONDARY Change in Bone Structure |
369.68; 373.90; 371.28; 372.29; 376.24; 382.25 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01747447). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.