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Clinical trial

Diabetes Prevention in the Vitamin D and Omega-3 Trial

ID
Name
0308112690000
Description
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 proposed study 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.
Trial arms
Trial start
2010-09-01
Estimated PCD
2024-05-30
Trial end
2024-05-30
Status
Active (not recruiting)
Treatment
Vitamin D3
Vitamin D3 (cholecalciferol), 2000 IU per day.
Arms:
Vitamin D and Omega-3, Vitamin D and Omega-3 placebo
Other names:
cholecalciferol
Omega-3 fatty acid (fish oil)
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 \[DHA\]).
Arms:
Vitamin D and Omega-3, Vitamin D placebo and Omega-3
Other names:
fish oil, eicosapentaenoic acid, docosahexaenoic acid, EPA, DHA, Omacor®
Vitamin D3 placebo
Vitamin D3 placebo
Arms:
Vitamin D placebo and Omega-3, Vitamin D placebo and Omega-3 placebo
Fish oil placebo
Fish oil placebo
Arms:
Vitamin D and Omega-3 placebo, Vitamin D placebo and Omega-3 placebo
Size
25875
Primary endpoint
Incident type 2 diabetes
5 years
Eligibility criteria
Participants in VITAL (NCT01169259) who have no history of diabetes mellitus at baseline are eligible to participate in this ancillary study.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'FACTORIAL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 25875, 'type': 'ACTUAL'}}
Updated at
2023-05-31

1 organization

2 products

1 indication

Organization
Brigham and Women's Hospital
Product
Omega-3
Indication
Type 2 Diabetes
Product
Fish oil