Vitamin D and Omega-3 Adiposity Trial (VITAL Adiposity)

Status unconfirmed · Not applicable · Has a placebo group

Conditions studied: Adiposity

In brief

The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is a randomized clinical trial in 20,000 U.S. men and women investigating whether taking daily dietary supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (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 (VITAL Adiposity) is being conducted among participants in VITAL and will examine the effect of vitamin D or fish oil on changes in body composition and adiposity (baseline compared to 2 year, as measured by anthropometric indices, total and regional body fat and adipokines) and assess whether changes in cardiovascular risk factors (lipids, glucose tolerance, blood pressure) are mediated by these parameters. How achieved 25(OH)D levels are affected by body composition and body mass will also be assessed.

Key facts

Study ID

NCT01785004

Run by

Brigham and Women's Hospital

People needed

600

Starts

2012-07-01

Expected to finish

2022-07-01

Last updated by the study team

2021-04-13

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Participants in VITAL (NCT 01169259) who are willing to participate in this ancillary study and undergo DXA evaluation (baseline and 2 years)

You may not qualify if…

• Inability to travel to the Clinical and Translational Science Center in Boston where imaging, anthropometric measurements, and blood work will be performed.

Where it is running

• Brigham and Women's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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