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

NCT02271230 | Completed Phase 3 Results

• 1 other identifier: 2014P001206
• Study Type: interventional
• Target: 25,871
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of Recurrent Heart Failure Hospitalization

  5 years

Study Arms (4)

Vitamin D and fish oil

EXPERIMENTAL

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

Drug: Vitamin D and fish oil

Vitamin D alone

PLACEBO COMPARATOR

2000 IU Vitamin D and fish oil placebo

Drug: Vitamin D alone

Fish oil (EPA/DHA) alone

EXPERIMENTAL

1 g per day of fish oil and vitamin D placebo

Dietary Supplement: Fish oil (EPA/DHA) alone

Fish oil and vitamin D placebo

PLACEBO COMPARATOR

Placebo for both vitamin D and fish oil

Other: Placebo

Interventions

Vitamin D and fish oil DRUG

2000 IU vitamin D and 1g/d fish oil

Vitamin D and fish oil

Fish oil (EPA/DHA) alone DIETARY_SUPPLEMENT

1 g/d fish oil

Fish oil (EPA/DHA) alone

Vitamin D alone DRUG

2000 IU vitamin D

Vitamin D alone

Placebo OTHER

Vitamin D placebo and fish oil placebo

Fish oil and vitamin D placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02120, United States

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Vitamin D; Fish Oils; Single Person

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Oils; Lipids; Marital Status; Family Characteristics; Demography; Population Characteristics; Socioeconomic Factors

Results Point of Contact

• Title: Dr. Luc Djousse
• Organization: Brigham and Women's Hospital

ldjousse@rics.bwh.harvard.edu

617-525-7591

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research, Associate Professor of Medicine

Study Record Dates

• First Submitted: October 7, 2014
• First Posted: October 22, 2014
• Study Start: August 1, 2014
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: March 18, 2022
• Results First Posted: March 18, 2022

Record last verified: 2022-02

Locations

US (1)