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NCT02271230 · ClinicalTrials.gov registry record · Phase 3

Intervention With Vitamin D and Omega-3 Supplements and Incident Heart Failure

A Phase 3 study of Heart Failure, sponsored by Brigham and Women's Hospital.

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

NCT02271230: Completed Phase 3 study of Heart Failure, sponsored by Brigham and Women's Hospital.

NCT02271230 is a Phase 3 study of Heart Failure that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 25,871 participants, above the 1,984-participant average among 397 other Heart Failure trials with a reported enrollment target (1204% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02271230, a Phase 3 study of Heart Failure, has completed, sponsored by Brigham and Women's Hospital.

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

Study Summary

This study will examine whether an intervention with vitamin D or fish oil supplements can reduce the risk of heart failure among adult men and women during a follow up period of up to five years (starting from the time of randomization into the parent VITAL trial). The investigators hypotheses are that both vitamin D and fish oil supplements will each reduce the risk of heart failure.

Primary Outcome

We will consider any hospitalization for heart failure among participants enrolled in the parent VITAL trial for this ancillary study. Incident heart failure are initially captured through annual questionnaires with subsequent validation by a team of physicians with expertise in cardiovascular medicine and epidemiology. We excluded 36 participants with prevalent heart failure at the time of randomization for the primary analysis.

Conditions Studied

Interventions

  • OTHER Placebo
  • DRUG Vitamin D and fish oil
  • DIETARY_SUPPLEMENT Fish oil (EPA/DHA) alone
  • DRUG Vitamin D alone

Study Locations (1)

Massachusetts

  • Brigham and Women's Hospital - Boston

Trial Details

FieldValue
Enrollment Target 25,871 participants
Start Date 2014-08
Est. Completion 2019-12
Phase Phase 3
Brigham and Women's Hospital

937 total trials

What the finished NCT02271230 record still lists

NCT02271230 is an interventional study that assigns participants to a tested intervention. Its 25,871 participants enrollment target places it among the larger protocols in the corpus, above the 1,984-participant average among 397 other Heart Failure trials with a reported enrollment target (1204% higher).

The record links to 1 condition, with Heart Failure appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.

NCT02271230 reports a single indexed study location in Massachusetts.

Frequently Asked Questions

What is clinical trial NCT02271230 about?

NCT02271230 is a clinical study titled "Intervention With Vitamin D and Omega-3 Supplements and Incident Heart Failure". This study will examine whether an intervention with vitamin D or fish oil supplements can reduce the risk of heart failure among adult men and women during a follow up period of up to five years (starting from the time of randomization into the parent VITAL trial). The investigators hypotheses are ...

What is the current status of trial NCT02271230?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 25,871 participants. The study started on 2014-08. Estimated completion is 2019-12.

What conditions does trial NCT02271230 study?

This clinical trial studies the following conditions: Heart Failure.

What interventions are being tested in trial NCT02271230?

The interventions under investigation include: Placebo (OTHER), Vitamin D and fish oil (DRUG), Fish oil (EPA/DHA) alone (DIETARY_SUPPLEMENT), Vitamin D alone (DRUG).

Who is sponsoring clinical trial NCT02271230?

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

Where is trial NCT02271230 being conducted?

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

Similar trials for Heart Failure

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02271230's enrollment target sits among peer trials

25,871 7th of 397 higher than 391 of 397 other Heart Failure trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Heart Failure trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02271230, the US trial registry maintained by the National Library of Medicine. NCT02271230 (large enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.