Infections, Human Cathelicidin Antimicrobial Peptide (hCAP-18)
Conditions
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
DIETARY_SUPPLEMENTvitamin D3
Vitamin D3 (cholecalciferol), 2000 IU per day
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_SUPPLEMENTVitamin D3 placebo
DIETARY_SUPPLEMENTfish oil placebo
Sponsors
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Participants in VITAL (NCT 01169259) are eligible to participate in this ancillary study. Please see NCT 01169259 for lists of inclusion and
Exclusion criteria
.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| upper respiratory infection | one year |
| hCAP-18 | one year |
Secondary
| Measure | Time frame |
|---|---|
| cellulitis | 5 years |
| lower respiratory infection | 5 years |
| infection-related hospitalizations | 5 years |
| antimicrobial-treated infection | 5 years |
| urinary tract infection | 5 years |
Countries
United States
Outcome results
None listed