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NCT01633177CompletedPhase 3

Study of Vitamin D and Omega-3 Supplementation for Preventing Diabetes

Diabetes Prevention in the Vitamin D and Omega-3 Trial

Source: ClinicalTrials.gov · Last updated 3 Apr 2026

Brief summary (registry, in English)

The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is an ongoing randomized clinical trial in 25,875 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 nondiabetic participants in VITAL and will examine whether vitamin D or fish oil prevent type 2 diabetes. Findings from this ancillary study (n=22220 without diabetes at baseline) conducted within the VITAL trial will clarify whether vitamin D and omega-3 fatty acid supplementation reduces risk of type 2 diabetes and thus will inform public health and clinical guidelines for diabetes prevention.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
22220 (actual)
First submitted
26 Jun 2012
Start date
Nov 2011
Primary completion date
30 May 2024
Lead sponsor
Brigham and Women's Hospital
NCT number
NCT01633177

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 22220
  • From Nov 2011 to the primary completion date, 30 May 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Criteria the registry did not label

  • Participants in VITAL (NCT01169259) who have no history of diabetes mellitus at baseline are eligible to participate in this ancillary study.

Age in the registry: 50 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Division of Preventive Medicine, Brigham and Women's Hospital
Coordinator of this site? Confirm its status
BostonUnited StatesUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.