Status:
COMPLETED
Intervention With Vitamin D and Omega-3 Supplements and Incident Heart Failure
Lead Sponsor:
Brigham and Women's Hospital
Conditions:
Heart Failure
Eligibility:
All Genders
50+ years
Phase:
PHASE3
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 (sta...
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 i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2019
Estimated Enrollment :
25871 Patients enrolled
Trial Details
Trial ID
NCT02271230
Start Date
August 1 2014
End Date
December 1 2019
Last Update
March 18 2022
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02120