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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02271230
• Other study ID #: 2014P001206
• Status: Completed
• Phase: Phase 3
• Start date: August 2014
• Est. completion date: December 2019

Study information

• Verified date: February 2022
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 25871
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Drug:
• Vitamin D and fish oil
2000 IU vitamin D and 1g/d fish oil

Dietary Supplement:
• Fish oil (EPA/DHA) alone
1 g/d fish oil

Drug:
• Vitamin D alone
2000 IU vitamin D

Other:
• Placebo
Vitamin D placebo and fish oil placebo

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With New Heart Failure Hospitalization	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.	5 years
Secondary	Number of Recurrent Heart Failure Hospitalization	Recurrent heart failure hospitalizations ascertained either by review of medical records and/or use of CMS (Center for Medicare and Medicaid Services) data.	5 years

External Links

•   Link to published results at Circulation