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

Not Applicable

Active, not recruiting

• Conditions: Infections; Human Cathelicidin Antimicrobial Peptide (hCAP-18)
• Interventions: Dietary Supplement: vitamin D3; Drug: omega-3 fatty acids (fish oil); Dietary Supplement: fish oil placebo; Dietary Supplement: Vitamin D3 placebo

• Registration Number: NCT01758081
• Lead Sponsor: Brigham and Women's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2012-12-24
• Study First Submitted QC: 2012-12-24
• Study First Posted: 2013-01-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-10
• Last Update Posted: 2024-08-13
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 25874

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
vitamin D + fish oil placebo	vitamin D3	vitamin D3 + fish oil placebo
vitamin D + fish oil	vitamin D3	vitamin D3 + Omacor
vitamin D + fish oil	omega-3 fatty acids (fish oil)	vitamin D3 + Omacor
vitamin D + fish oil placebo	fish oil placebo	vitamin D3 + fish oil placebo
vitamin D placebo + fish oil	omega-3 fatty acids (fish oil)	vitamin D placebo + Omacor
vitamin D placebo + fish oil	Vitamin D3 placebo	vitamin D placebo + Omacor
vitamin D placebo + fish oil placebo	Vitamin D3 placebo	vitamin D placebo + fish oil placebo
vitamin D placebo + fish oil placebo	fish oil placebo	vitamin D placebo + fish oil placebo

Primary Outcome Measures

Name	Time	Method
upper respiratory infection	one year
hCAP-18	one year

Secondary Outcome Measures

Name	Time	Method
lower respiratory infection	5 years
urinary tract infection	5 years
cellulitis	5 years
antimicrobial-treated infection	5 years
infection-related hospitalizations	5 years

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States