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

NCT ID: NCT02271230

Last Updated: 2022-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 25871 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2019-12-31

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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Vitamin D and fish oil

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

Group Type: EXPERIMENTAL

Vitamin D and fish oil

Intervention Type: DRUG

2000 IU vitamin D and 1g/d fish oil

Vitamin D alone

2000 IU Vitamin D and fish oil placebo

Group Type: PLACEBO_COMPARATOR

Vitamin D alone

Intervention Type: DRUG

2000 IU vitamin D

Fish oil (EPA/DHA) alone

1 g per day of fish oil and vitamin D placebo

Group Type: EXPERIMENTAL

Fish oil (EPA/DHA) alone

Intervention Type: DIETARY_SUPPLEMENT

1 g/d fish oil

Fish oil and vitamin D placebo

Placebo for both vitamin D and fish oil

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Vitamin D placebo and fish oil placebo

Interventions

Vitamin D and fish oil

2000 IU vitamin D and 1g/d fish oil

Intervention Type: DRUG

Fish oil (EPA/DHA) alone

1 g/d fish oil

Intervention Type: DIETARY_SUPPLEMENT

Vitamin D alone

2000 IU vitamin D

Intervention Type: DRUG

Placebo

Vitamin D placebo and fish oil placebo

Intervention Type: OTHER

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Luc Djousse

Director of Research, Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2014P001206

Identifier Type: -

Identifier Source: org_study_id