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

NCT02271230 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 25871

Last updated 2022-03-18

Study results available
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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.

Conditions

Interventions

DRUG

Vitamin D and fish oil

2000 IU vitamin D and 1g/d fish oil

DIETARY_SUPPLEMENT

Fish oil (EPA/DHA) alone

1 g/d fish oil

DRUG

Vitamin D alone

2000 IU vitamin D

OTHER

Placebo

Vitamin D placebo and fish oil placebo

Sponsors & Collaborators

  • Brigham and Women's Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02271230 on ClinicalTrials.gov