Overview

This trial is active, not recruiting.

Conditions infections, human cathelicidin antimicrobial peptide (hcap-18)
Treatments vitamin d3, omega-3 fatty acids (fish oil), vitamin d3 placebo, fish oil placebo
Sponsor Brigham and Women's Hospital
Start date July 2010
End date October 2017
Trial size 25874 participants
Trial identifier NCT01758081, AI093723

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Active Comparator)
vitamin D3 + Omacor
vitamin d3
Vitamin D3 (cholecalciferol), 2000 IU per day
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])
(Active Comparator)
vitamin D3 + fish oil placebo
vitamin d3
Vitamin D3 (cholecalciferol), 2000 IU per day
fish oil placebo
(Active Comparator)
vitamin D placebo + Omacor
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])
vitamin d3 placebo
(Placebo Comparator)
vitamin D placebo + fish oil placebo
vitamin d3 placebo
fish oil placebo

Primary Outcomes

Measure
upper respiratory infection
time frame: one year
hCAP-18
time frame: one year

Secondary Outcomes

Measure
lower respiratory infection
time frame: 5 years
urinary tract infection
time frame: 5 years
cellulitis
time frame: 5 years
antimicrobial-treated infection
time frame: 5 years
infection-related hospitalizations
time frame: 5 years

Eligibility Criteria

Male or female participants at least 50 years old.

Participants in VITAL (NCT 01169259) are eligible to participate in this ancillary study. Please see NCT 01169259 for lists of inclusion and exclusion criteria.

Additional Information

Official title Effects of Vitamin D and Omega-3 Fatty Acids on Infectious Diseases and hCAP18
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Brigham and Women's Hospital.