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NCT Number: NCT01758081

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Infections Human Cathelicidin Antimicrobial Peptide (hCAP-18)

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02215, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D3

Dietary Supplement

Vitamin D3 (cholecalciferol), 2000 IU per day

omega-3 fatty acids (fish oil)

Drug

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

Dietary Supplement

Fish oil placebo

Dietary Supplement

Primary outcomes

  1. upper respiratory infection

    Time frame: one year

  2. hCAP-18

    Time frame: one year

Secondary outcomes

  1. lower respiratory infection

    Time frame: 5 years

  2. urinary tract infection

    Time frame: 5 years

  3. cellulitis

    Time frame: 5 years

  4. antimicrobial-treated infection

    Time frame: 5 years

  5. infection-related hospitalizations

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2026
Study completion
2026
First posted
Jan 1, 2013
Registry last updated
Sep 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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