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

Mass General Brigham

Status: Active, not recruiting

Conditions: Human Cathelicidin Antimicrobial Peptide (hCAP-18); Infections

Treatments: Dietary Supplement: vitamin D3; Drug: omega-3 fatty acids (fish oil); Dietary Supplement: Vitamin D3 placebo; Dietary Supplement: fish oil placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01758081

AI093723

Details and patient eligibility

About

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.

Enrollment: 25,874 patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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25,874 participants in 4 patient groups, including a placebo group

vitamin D + fish oil

Active Comparator group

Description:

vitamin D3 + Omacor

Treatment:

Drug: omega-3 fatty acids (fish oil)

Dietary Supplement: vitamin D3

vitamin D + fish oil placebo

Active Comparator group

Description:

vitamin D3 + fish oil placebo

Treatment:

Dietary Supplement: fish oil placebo

Dietary Supplement: vitamin D3

vitamin D placebo + fish oil

Active Comparator group

Description:

vitamin D placebo + Omacor

Treatment:

Dietary Supplement: Vitamin D3 placebo

Drug: omega-3 fatty acids (fish oil)

vitamin D placebo + fish oil placebo

Placebo Comparator group

Description:

vitamin D placebo + fish oil placebo

Treatment:

Dietary Supplement: fish oil placebo

Dietary Supplement: Vitamin D3 placebo