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

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ClinicalTrials.gov Identifier: NCT02271230
Recruitment Status : Completed
First Posted : October 22, 2014
Results First Posted : March 18, 2022
Last Update Posted : March 18, 2022
Sponsor:
Information provided by (Responsible Party):
Luc Djousse, Brigham and Women's Hospital

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.

Condition or disease Intervention/treatment Phase
Heart Failure Drug: Vitamin D and fish oil Dietary Supplement: Fish oil (EPA/DHA) alone Drug: Vitamin D alone Other: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25871 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Intervention With Vitamin D and Omega-3 Supplements and Incident Heart Failure
Study Start Date : August 2014
Actual Primary Completion Date : December 2019
Actual Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Vitamin D and fish oil
2000 IU per day and 1 g per day of fish oil
Drug: Vitamin D and fish oil
2000 IU vitamin D and 1g/d fish oil

Placebo Comparator: Vitamin D alone
2000 IU Vitamin D and fish oil placebo
Drug: Vitamin D alone
2000 IU vitamin D

Experimental: Fish oil (EPA/DHA) alone
1 g per day of fish oil and vitamin D placebo
Dietary Supplement: Fish oil (EPA/DHA) alone
1 g/d fish oil

Placebo Comparator: Fish oil and vitamin D placebo
Placebo for both vitamin D and fish oil
Other: Placebo
Vitamin D placebo and fish oil placebo




Primary Outcome Measures :
  1. Number of Participants With New Heart Failure Hospitalization [ Time Frame: 5 years ]
    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 :
  1. Number of Recurrent Heart Failure Hospitalization [ Time Frame: 5 years ]
    Recurrent heart failure hospitalizations ascertained either by review of medical records and/or use of CMS (Center for Medicare and Medicaid Services) data.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02271230


Locations
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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02120
Sponsors and Collaborators
Brigham and Women's Hospital
  Study Documents (Full-Text)

Documents provided by Luc Djousse, Brigham and Women's Hospital:
Additional Information:
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Responsible Party: Luc Djousse, Director of Research, Associate Professor of Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02271230    
Other Study ID Numbers: 2014P001206
First Posted: October 22, 2014    Key Record Dates
Results First Posted: March 18, 2022
Last Update Posted: March 18, 2022
Last Verified: February 2022
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Vitamin D
Ergocalciferols
Cholecalciferol
Vitamins
Micronutrients
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents