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

Primary Purpose

Heart Failure

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Vitamin D and fish oil
Fish oil (EPA/DHA) alone
Vitamin D alone
Placebo
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Heart Failure

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Vitamin D and fish oil

Vitamin D alone

Fish oil (EPA/DHA) alone

Fish oil and vitamin D placebo

Arm Description

2000 IU per day and 1 g per day of fish oil

2000 IU Vitamin D and fish oil placebo

1 g per day of fish oil and vitamin D placebo

Placebo for both vitamin D and fish oil

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
October 7, 2014
Last Updated
February 23, 2022
Sponsor
Brigham and Women's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02271230
Brief Title
Intervention With Vitamin D and Omega-3 Supplements and Incident Heart Failure
Official Title
Intervention With Vitamin D and Omega-3 Supplements and Incident Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
December 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital

4. Oversight

5. Study Description

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 (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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
25871 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitamin D and fish oil
Arm Type
Experimental
Arm Description
2000 IU per day and 1 g per day of fish oil
Arm Title
Vitamin D alone
Arm Type
Placebo Comparator
Arm Description
2000 IU Vitamin D and fish oil placebo
Arm Title
Fish oil (EPA/DHA) alone
Arm Type
Experimental
Arm Description
1 g per day of fish oil and vitamin D placebo
Arm Title
Fish oil and vitamin D placebo
Arm Type
Placebo Comparator
Arm Description
Placebo for both vitamin D and fish oil
Intervention Type
Drug
Intervention Name(s)
Vitamin D and fish oil
Intervention Description
2000 IU vitamin D and 1g/d fish oil
Intervention Type
Dietary Supplement
Intervention Name(s)
Fish oil (EPA/DHA) alone
Intervention Description
1 g/d fish oil
Intervention Type
Drug
Intervention Name(s)
Vitamin D alone
Intervention Description
2000 IU vitamin D
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Vitamin D placebo and fish oil placebo
Primary Outcome Measure Information:
Title
Number of Participants With New Heart Failure Hospitalization
Description
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.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Number of Recurrent Heart Failure Hospitalization
Description
Recurrent heart failure hospitalizations ascertained either by review of medical records and/or use of CMS (Center for Medicare and Medicaid Services) data.
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02120
Country
United States

12. IPD Sharing Statement

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

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