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

NCT ID: NCT01758081

Last Updated: 2025-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

25874 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2026-12-31

Brief Summary

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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 (OmacorĀ® 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

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Conditions

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Infections Human Cathelicidin Antimicrobial Peptide (hCAP-18)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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vitamin D + fish oil

vitamin D3 + Omacor

Group Type ACTIVE_COMPARATOR

vitamin D3

Intervention Type DIETARY_SUPPLEMENT

Vitamin D3 (cholecalciferol), 2000 IU per day

omega-3 fatty acids (fish oil)

Intervention Type 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 D + fish oil placebo

vitamin D3 + fish oil placebo

Group Type ACTIVE_COMPARATOR

vitamin D3

Intervention Type DIETARY_SUPPLEMENT

Vitamin D3 (cholecalciferol), 2000 IU per day

fish oil placebo

Intervention Type DIETARY_SUPPLEMENT

vitamin D placebo + fish oil

vitamin D placebo + Omacor

Group Type ACTIVE_COMPARATOR

omega-3 fatty acids (fish oil)

Intervention Type 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

Intervention Type DIETARY_SUPPLEMENT

vitamin D placebo + fish oil placebo

vitamin D placebo + fish oil placebo

Group Type PLACEBO_COMPARATOR

Vitamin D3 placebo

Intervention Type DIETARY_SUPPLEMENT

fish oil placebo

Intervention Type DIETARY_SUPPLEMENT

Interventions

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vitamin D3

Vitamin D3 (cholecalciferol), 2000 IU per day

Intervention Type DIETARY_SUPPLEMENT

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 \[DHA\])

Intervention Type DRUG

Vitamin D3 placebo

Intervention Type DIETARY_SUPPLEMENT

fish oil placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

Participants in VITAL (NCT 01169259) are eligible to participate in this ancillary study.

Exclusion Criteria

Please see NCT 01169259 for lists of inclusion and exclusion criteria.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Carlos A. Camargo

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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Manson JE, Bassuk SS, Lee IM, Cook NR, Albert MA, Gordon D, Zaharris E, Macfadyen JG, Danielson E, Lin J, Zhang SM, Buring JE. The VITamin D and OmegA-3 TriaL (VITAL): rationale and design of a large randomized controlled trial of vitamin D and marine omega-3 fatty acid supplements for the primary prevention of cancer and cardiovascular disease. Contemp Clin Trials. 2012 Jan;33(1):159-71. doi: 10.1016/j.cct.2011.09.009. Epub 2011 Oct 2.

Reference Type BACKGROUND
PMID: 21986389 (View on PubMed)

Bassuk SS, Manson JE, Lee IM, Cook NR, Christen WG, Bubes VY, Gordon DS, Copeland T, Friedenberg G, D'Agostino DM, Ridge CY, MacFadyen JG, Kalan K, Buring JE. Baseline characteristics of participants in the VITamin D and OmegA-3 TriaL (VITAL). Contemp Clin Trials. 2016 Mar;47:235-43. doi: 10.1016/j.cct.2015.12.022. Epub 2016 Jan 6.

Reference Type BACKGROUND
PMID: 26767629 (View on PubMed)

Related Links

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http://www.vitalstudy.org/

VITAL study website

Other Identifiers

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AI093723

Identifier Type: -

Identifier Source: org_study_id

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