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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Heart Failure

Intervention / Treatment
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* Drug: Vitamin D and fish oil
* Dietary Supplement: Fish oil (EPA/DHA) alone
* Drug: Vitamin D alone
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D and fish oil<br>2000 IU per day and 1 g per day of fish oil | Drug: Vitamin D and fish oil<br>* 2000 IU vitamin D and 1g/d fish oil<br>|
| Placebo Comparator: Vitamin D alone<br>2000 IU Vitamin D and fish oil placebo | Drug: Vitamin D alone<br>* 2000 IU vitamin D<br>|
| Experimental: Fish oil (EPA/DHA) alone<br>1 g per day of fish oil and vitamin D placebo | Dietary Supplement: Fish oil (EPA/DHA) alone<br>* 1 g/d fish oil<br>|
| Placebo Comparator: Fish oil and vitamin D placebo<br>Placebo for both vitamin D and fish oil | Other: Placebo<br>* Vitamin D placebo and fish oil placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With New Heart Failure Hospitalization | 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. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Recurrent Heart Failure Hospitalization | Recurrent heart failure hospitalizations ascertained either by review of medical records and/or use of CMS (Center for Medicare and Medicaid Services) data. | 5 years |