Intervention With Vitamin D and Omega-3 Supplements and Incident Heart Failure
This trial is active, not recruiting.
|Treatments||vitamin d and fish oil, fish oil (epa/dha) alone, vitamin d alone, placebo|
|Sponsor||Brigham and Women's Hospital|
|Start date||August 2014|
|End date||December 2020|
|Trial size||25875 participants|
|Trial identifier||NCT02271230, 2014P001206|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||factorial assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
Incident heart failure hospitalization
time frame: up to five years (starting from the time of randomization into the parent VITAL trial)
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
|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.|
Call for more information