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

• Status: Completed
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital
• Treatments: Ergocalciferols; Vitamin D; Vitamins

Criteria

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