Active Not Recruiting
NA
INTERVENTIONAL
NCT01758081
Effects of Vitamin D and Omega-3 Fatty Acids on Infectious Diseases and hCAP18 (VITAL Infection)
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
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 participants in VITAL and will examine whether vitamin D or omega-3 fatty acids affect risk of infection and plasma hCAP18 levels.
Interventions
Name:
vitamin D3
Type:
DIETARY_SUPPLEMENT
Description:
Vitamin D3 (cholecalciferol), 2000 IU per day
Name:
omega-3 fatty acids (fish oil)
Type:
DRUG
Description:
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 \[DHA\])
Name:
Vitamin D3 placebo
Type:
DIETARY_SUPPLEMENT
Description:
Name:
fish oil placebo
Type:
DIETARY_SUPPLEMENT
Description:
Primary Outcomes
Measure:
upper respiratory infection
TimeFrame:
one year
Description:
Measure:
hCAP-18
TimeFrame:
one year
Description:
Trial Information
NCT ID
NCT01758081
Status
Active Not Recruiting
Study Type
INTERVENTIONAL
Phases
NA
Sponsor
Brigham and Women's Hospital
Last Updated
December 15, 2025