NCT01653678

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. The VITAL Hypertension ancillary study is being conducted among participants in VITAL and will examine whether vitamin D or omega-3 fatty acids are related to changes in blood pressure and hypertension.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
25,875

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
1mo left

Started Nov 2011

Longer than P75 for not_applicable hypertension

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 Start

First participant enrolled

November 1, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 31, 2012

Completed
13.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

December 18, 2025

Status Verified

December 1, 2025

Enrollment Period

14 years

First QC Date

July 27, 2012

Last Update Submit

December 17, 2025

Conditions

Hypertension

Keywords

vitamin D-3omega-3 fatty acidsfish oilhypertensionblood pressure

Outcome Measures

Primary Outcomes (5)

  • Change in blood pressure

    Change in 24-hour ambulatory blood pressure measurements among a subcohort of approximately 1,000 participants.

    Two years

  • Incident hypertension

    Incidence of hypertension in the overall VITAL trial cohort.

    5 years

  • Changes in 25-hydroxy-vitamin D levels

    Changes in a subcohort of approximately 1,000 participants.

    2 years

  • Changes in fatty acid levels

    Changes in a subcohort of approximately 1,000 participants

    2 years

  • Changes in biomarkers related to blood pressure

    Changes in a subcohort of approximately 1,000 participants

    2 years

Study Arms (4)

Vitamin D + fish oil

ACTIVE COMPARATOR
Dietary Supplement: Vitamin D-3 (cholecalciferol), 2000 IUDrug: Omega-3 fatty acids (fish oil)

Vitamin D + fish oil placebo

ACTIVE COMPARATOR
Dietary Supplement: Vitamin D-3 (cholecalciferol), 2000 IUDrug: Fish oil placebo

Vitamin D placebo + fish oil

ACTIVE COMPARATOR
Drug: Omega-3 fatty acids (fish oil)Dietary Supplement: Vitamin D placebo

Vitamin D placebo + fish oil placebo

PLACEBO COMPARATOR
Dietary Supplement: Vitamin D placeboDrug: Fish oil placebo

Interventions

Vitamin D-3 (cholecalciferol), 2000 IUDIETARY_SUPPLEMENT
Also known as: cholecalciferol
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 D placeboDIETARY_SUPPLEMENT
Vitamin D placebo + fish oilVitamin D placebo + fish oil placebo
Fish oil placeboDRUG
Vitamin D + fish oil placeboVitamin D placebo + fish oil placebo

Eligibility Criteria

Age50 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Participants eligible and willing to participate in the main VITAL trial (NCT 01169259) who meet the following criteria are eligible to participate in the VITAL Hypertension ancillary study: all participants with no baseline history of hypertension and, for home visits in the subcohort of 1,000 participants, those living in selected cities throughout the U.S..

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02215, United States

Location

Related Links

MeSH Terms

Conditions

Hypertension

Interventions

CholecalciferolFatty Acids, Omega-3Fish Oils

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Howard D. Sesso, ScD, MPH

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

  • John P. Forman, MD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 27, 2012

First Posted

July 31, 2012

Study Start

November 1, 2011

Primary Completion

November 1, 2025

Study Completion (Estimated)

June 1, 2026

Last Updated

December 18, 2025

Record last verified: 2025-12

Locations

US(1)