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

• 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: Brigham and Women's Hospital
• Information provided by (Responsible Party): Luc Djousse, Brigham and Women's Hospital

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.

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

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:

Study Protocol and Statistical Analysis Plan  [PDF] December 31, 2020

More Information

Additional Information:

Link to published results at Circulation 

• 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
• Results First Posted: March 18, 2022
• Last Update Posted: March 18, 2022
• Last Verified: February 2022

Additional relevant MeSH terms:

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