NCT01758081

Effects of Vitamin D and Omega-3 Fatty Acids on Infectious Diseases and hCAP18 (VITAL Infection)

Effects of Vitamin D and Omega-3 Fatty Acids on Infectious Diseases and hCAP18

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 25,874 (actual)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Infections
• Human Cathelicidin Antimicrobial Peptide (hCAP-18)

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	vitamin D3	Vitamin D3 (cholecalciferol), 2000 IU per day
DRUG	omega-3 fatty acids (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 \[DHA\])
DIETARY_SUPPLEMENT	Vitamin D3 placebo
DIETARY_SUPPLEMENT	fish oil placebo

Timeline

• Start date: 2010-07-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2013-01-01
• Last updated: 2025-09-25

Locations

1 site across 1 country: United States