CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 771 enrolled
Drug / intervention
Vitamin D3 placebo +3 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01747447
NCT01747447N/ACompleted

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

Brigham and Women's Hospital·interventional·Posted Dec 11, 2012·Updated Apr 28, 2026

In Brief

A clinical study evaluating Vitamin D3 placebo, Fish oil placebo, and 2 other interventions for Bone Density and 2 related conditions. Completed, enrolled 771 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedDec 11, 2012
Enrollment StartAug 1, 2012
Primary CompletionDec 1, 2017
Study CompletionAug 2, 2023
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 13.6 years ago

Interventions

Vitamin D3 placebodietary

Vitamin D placebo

Fish oil placebodietary

Fish oil placebo

omega-3 fatty acids (fish oil)dietary

Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \[EPA\] and 375 mg of docosahexaenoic acid \[DHA\]).

Vitamin D3dietary

Vitamin D3 (cholecalciferol), 2000 IU per day.