Overview

This trial is active, not recruiting.

Condition heart failure
Treatments vitamin d and fish oil, fish oil (epa/dha) alone, vitamin d alone, placebo
Phase phase 3
Sponsor Brigham and Women's Hospital
Start date August 2014
End date December 2020
Trial size 25875 participants
Trial identifier NCT02271230, 2014P001206

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model factorial assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
2000 IU per day and 1 g per day of fish oil
vitamin d and fish oil
2000 IU vitamin D and 1g/d fish oil
(Placebo Comparator)
2000 IU Vitamin D and fish oil placebo
vitamin d alone
2000 IU vitamin D
(Experimental)
1 g per day of fish oil and vitamin D placebo
fish oil (epa/dha) alone
1 g/d fish oil
(Placebo Comparator)
Placebo for both vitamin D and fish oil
placebo
Vitamin D placebo and fish oil placebo

Primary Outcomes

Measure
Incident heart failure hospitalization
time frame: up to five years (starting from the time of randomization into the parent VITAL trial)

Eligibility Criteria

Male or female participants at least 50 years old.

Inclusion Criteria: - Men aged 50 or older or women aged 55 or older - Be consuming no more than 800 IU of vitamin D from all supplemental sources combined (individual vitamin D supplements, calcium+vitamin D supplements, medications with vitamin D [e.g., Fosamax Plus D], and multivitamins), or, if taking, willing to decrease or forego such use during the trial; - Be consuming no more than 1200 mg/d of calcium from all supplemental sources combined, or, if taking, willing to decrease or forego such use during the trial; - Not be taking fish oil supplements, or, if taking, willing to forego their use during the trial Exclusion Criteria: - prevalent heart failure - History of cancer (except non-melanoma skin cancer), heart attack, stroke, transient ischemic attack, angina pectoris, CABG, or PCI - History of renal failure or dialysis, hypercalcemia, hypo- or hyperparathyroidism, severe liver disease (cirrhosis), or sarcoidosis or other granulomatous diseases such as active chronic tuberculosis or Wegener's granulomatosis; - Allergy to fish or soy

Additional Information

Description For this ancillary study of the ongoing parent VITAL trial, we will adjudicate incident heart failure cases occurring during a time period of up to five years starting from randomization of subjects in the parent VITAL study. Intention-to-treat analysis will be used to assess the efficacy of vitamin D as well as omega-3 fatty acids.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Brigham and Women's Hospital.