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

Phase 3

Completed

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

Brief 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.

Detailed 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Vitamin D and fish oil	Vitamin D and fish oil	2000 IU per day and 1 g per day of fish oil
Fish oil (EPA/DHA) alone	Fish oil (EPA/DHA) alone	1 g per day of fish oil and vitamin D placebo
Fish oil and vitamin D placebo	Placebo	Placebo for both vitamin D and fish oil
Vitamin D alone	Vitamin D alone	2000 IU Vitamin D and fish oil placebo

Primary Outcome Measures

Name	Time	Method
Number of Participants With New Heart Failure Hospitalization	5 years	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.

Secondary Outcome Measures

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