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NCT01169259 · ClinicalTrials.gov registry record · Phase 3

Vitamin D and Omega-3 Trial (VITAL)

A Phase 3 study of Cancer and Cardiovascular Disease, sponsored by Brigham and Women's Hospital.

Active
Registry status
Phase 3
Development phase
25,871
Enrollment target
1
Study location

NCT01169259 is a Phase 3 study of Cancer and Cardiovascular Disease that is active but no longer recruiting, run by Brigham and Women's Hospital. The registered enrollment target is 25,871 participants, above the 3,449-participant average among 615 other Cancer trials with a reported enrollment target (650% higher). The trial reports 1 study location across 1 state.

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The verdict

NCT01169259, a Phase 3 study of Cancer and Cardiovascular Disease, is active but no longer recruiting, sponsored by Brigham and Women's Hospital.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
25,871 participants
Enrollment target
1
Study location

Study Summary

The VITamin D and OmegA-3 TriaL (VITAL) is a randomized clinical trial in 25,871 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 5-year intervention phase (study pill-taking, median 5.3 years) has ended; post-intervention observational follow-up of study participants is ongoing.

Interventions

  • DIETARY_SUPPLEMENT vitamin D3
  • DIETARY_SUPPLEMENT Vitamin D3 placebo
  • DIETARY_SUPPLEMENT Fish oil placebo
  • DRUG omega-3 fatty acids (fish oil)

Study Locations (1)

Massachusetts

  • Brigham and Women's Hospital - Boston

Trial Details

FieldValue
Enrollment Target 25,871 participants
Start Date 2010-07
Est. Completion 2026-05
Phase Phase 3

Sponsor

Brigham and Women's Hospital

937 total trials

What the Registry Record Tells You About NCT01169259

The ClinicalTrials.gov registry entry for NCT01169259 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 25,871 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 3,449-participant average among 615 other Cancer trials with a reported enrollment target (650% higher). The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Cancer appearing as the primary indexed condition, and to 4 interventions - of which vitamin D3 is the first listed.

NCT01169259 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.

Frequently Asked Questions

What is clinical trial NCT01169259 about?

NCT01169259 is a clinical study titled "Vitamin D and Omega-3 Trial (VITAL)". The VITamin D and OmegA-3 TriaL (VITAL) is a randomized clinical trial in 25,871 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 peo...

What is the current status of trial NCT01169259?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 25,871 participants. The study started on 2010-07. Estimated completion is 2026-05.

What conditions does trial NCT01169259 study?

This clinical trial studies the following conditions: Cancer, Cardiovascular Disease.

What interventions are being tested in trial NCT01169259?

The interventions under investigation include: vitamin D3 (DIETARY_SUPPLEMENT), Vitamin D3 placebo (DIETARY_SUPPLEMENT), Fish oil placebo (DIETARY_SUPPLEMENT), omega-3 fatty acids (fish oil) (DRUG).

Who is sponsoring clinical trial NCT01169259?

This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01169259 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.