drugset / Trial / NCT02271230

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

NCT02271230 ↗

Phase 3 Completed 25871 enrolled Brigham and Women's Hospital
RandomizedFactorialQuadruple-blindPrevention

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.

Timeline

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

Outcome

Missed primary endpoint

registry Hazard Ratio (HR) 0.93 (95% CI 0.78 to 1.11) NCT02271230 ↗

registry Hazard Ratio (HR) 0.96 (95% CI 0.80 to 1.14) NCT02271230 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Fish oil Other / unclassified 1 g —
Subject Vitamin D Other / unclassified 2000 iu —

Indications