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

NCT01785004 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2021-04-13

No results posted yet for this study

Summary

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.

Conditions

  • Adiposity

Interventions

DIETARY_SUPPLEMENT

Vitamin D3 (cholecalciferol), 2000 IU per day

cholecalciferol

DRUG

omega-3 fatty acids (fish oil)

Sponsors & Collaborators

Principal Investigators

  • Jacqueline S. Danik, MD, DrPH · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2022-07-31
Completion
2022-07-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01785004 on ClinicalTrials.gov