Micronutrient Supplementation in Patients With Heart Failure (MINT-HF)

February 23, 2023 updated by: Pascal McKeown, Belfast Health and Social Care Trust

A Trial of Micronutrient Supplementation in Patients With Heart Failure

There is some evidence to suggest that patients with heart failure may have a reduced dietary intake of vitamins and essential minerals (micronutrients) and that this may worsen the function of the heart. This study is designed to investigate if supplementation with micronutrients (including high-dose vitamin D) will improve the function of the heart in patients with heart failure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

79

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Belfast, United Kingdom, BT12 6BA
        • Royal Victoria Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • New York Heart Association Class II and III
  • Already on or tried on best known medical treatment (ACE inhibitor and beta-blocker)
  • Stable for a period of at least 6 weeks
  • Left ventricular ejection fraction less than or equal to 45%

Exclusion Criteria:

  • History of significant alcohol ingestion (more than 40 units per week)
  • Severe renal dysfunction (GFR less than 30ml/min)
  • Severe hepatic dysfunction (known liver disease or transaminases greater than 3 times the upper limit of normal)
  • Atrial fibrillation (in the absence of a pacemaker)
  • Frequent ventricular ectopics
  • On waiting list for cardiac transplantation
  • Uncontrolled diabetes mellitus
  • Inability to give informed consent
  • Estimated life span less than 12 months
  • Already taking a multivitamin/mineral supplement
  • Already taking a vitamin-D containing fish oil
  • Woman of child-bearing potential
  • History of renal stones, hypercalcaemia, sarcoidosis, haemochromatosis or lactose intolerance

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
1 Tablet Daily
Active Comparator: Micronutrient
Drug: Forceval plus 50 micrograms Vitamin D3
Forceval: 1 Tablet Daily; Vitamin D3: 2 Tablets Daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Left Ventricular Ejection Fraction
Time Frame: Baseline, and 12 months
Baseline, and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life Questionnaire Score
Time Frame: Baseline, and 12 months
Minnesota Living With Heart Failure Questionnaire. The questionnaire is comprised of 21 questions around several physical, emotional and socioeconomic ways heart failure can adversely affect a patient's life. After receiving brief standardized instructions, the patient marks a 0 (zero) to 5 (five) scale to indicate the extent to which each itemized adversity of heart failure has prevented the patient from living as they wanted to live during the past 4 weeks. The questionnaire is simply scored by summation of all 21 responses (score range 0-105). Higher scores indicate worse quality of life.
Baseline, and 12 months
Six Minute Walk Test Distance
Time Frame: Baseline, and 12 months
Baseline, and 12 months
Serum N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) Concentration
Time Frame: Baseline, and 12 months
Baseline, and 12 months
Serum C-reactive Protein (CRP) Concentration
Time Frame: Baseline, and 12 months
Baseline, and 12 months
Serum Tumor Necrosis Factor-alpha (TNF-α) Concentration
Time Frame: Baseline, and 12 months
Baseline, and 12 months
Serum Interleukin-6 (IL-6) Concentration
Time Frame: Baseline, and 12 months
Baseline, and 12 months
Serum Interleukin-10 (IL-10) Concentration
Time Frame: Baseline, and 12 months
Baseline, and 12 months
Urinary 8-iso-prostaglandin F2 Alpha (8-iso-PGF2α) Concentration
Time Frame: Baseline, and 12 months
Baseline, and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Belfast Health and Social Care Trust

Investigators

  • Principal Investigator: Pascal McKeown, MD, Belfast Health and Social Care Trust
  • Study Director: Mark Harbinson, MD, Belfast Health and Socail Care Trust
  • Study Director: Michelle McKinley, PhD, The Queen's Univeristy of Belfast

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

October 29, 2009

First Submitted That Met QC Criteria

October 29, 2009

First Posted (Estimated)

October 30, 2009

Study Record Updates

Last Update Posted (Estimated)

December 1, 2023

Last Update Submitted That Met QC Criteria

February 23, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RGHT000395

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heart Failure

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sri Lanka

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe