Phase 3
Completed N=25,871
Intervention With Vitamin D and Omega-3 Supplements and Incident Heart Failure
Source: ClinicalTrials.gov NCT02271230 ↗Enrolled (actual)
25,871
Serious AEs
12.7%
Results posted
Mar 2022
Primary outcomePrimary: Number of Participants With New Heart Failure Hospitalization — 240; 259; 244; 255 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With New Heart Failure Hospitalization |
240; 259; 244; 255 | — |
| SECONDARY Number of Recurrent Heart Failure Hospitalization |
341; 364; 326; 379 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02271230). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.