NCT01758081

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25,874

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Jul 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Jul 2010Dec 2026

Study Start

First participant enrolled

July 1, 2010

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

December 24, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 1, 2013

Completed
13.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

September 25, 2025

Status Verified

September 1, 2025

Enrollment Period

16.4 years

First QC Date

December 24, 2012

Last Update Submit

September 22, 2025

Conditions

InfectionsHuman Cathelicidin Antimicrobial Peptide (hCAP-18)

Outcome Measures

Primary Outcomes (2)

  • upper respiratory infection

    one year

  • hCAP-18

    one year

Secondary Outcomes (5)

  • lower respiratory infection

    5 years

  • urinary tract infection

    5 years

  • cellulitis

    5 years

  • antimicrobial-treated infection

    5 years

  • infection-related hospitalizations

    5 years

Study Arms (4)

vitamin D + fish oil

ACTIVE COMPARATOR

vitamin D3 + Omacor

Dietary Supplement: vitamin D3Drug: omega-3 fatty acids (fish oil)

vitamin D + fish oil placebo

ACTIVE COMPARATOR

vitamin D3 + fish oil placebo

Dietary Supplement: vitamin D3Dietary Supplement: fish oil placebo

vitamin D placebo + fish oil

ACTIVE COMPARATOR

vitamin D placebo + Omacor

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

vitamin D placebo + fish oil placebo

PLACEBO COMPARATOR

vitamin D placebo + fish oil placebo

Dietary Supplement: Vitamin D3 placeboDietary Supplement: fish oil placebo

Interventions

vitamin D3DIETARY_SUPPLEMENT

Vitamin D3 (cholecalciferol), 2000 IU per day

vitamin D + fish oilvitamin D + fish oil placebo
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 D + fish oilvitamin D placebo + fish oil
Vitamin D3 placeboDIETARY_SUPPLEMENT
vitamin D placebo + fish oilvitamin D placebo + fish oil placebo
fish oil placeboDIETARY_SUPPLEMENT
vitamin D + fish oil placebovitamin D placebo + fish oil placebo

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02215, United States

Location

Related Publications (2)

  • 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.

    PMID: 21986389BACKGROUND

  • 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.

    PMID: 26767629BACKGROUND

Related Links

MeSH Terms

Conditions

Infections

Interventions

CholecalciferolFatty Acids, Omega-3Fish Oils

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipidsDietary Fats, UnsaturatedDietary FatsFatsFatty Acids, UnsaturatedFatty AcidsOils

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

December 24, 2012

First Posted

January 1, 2013

Study Start

July 1, 2010

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

September 25, 2025

Record last verified: 2025-09

Locations

US(1)