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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Belfast Health and Social Care Trust
ClinicalTrials.gov Identifier:
NCT01005303
First received: October 29, 2009
Last updated: June 21, 2011
Last verified: June 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Heart Failure
 Drug: Placebo
Drug: Forceval plus 50 micrograms Vitamin D3
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Trial of Micronutrient Supplementation in Patients With Heart Failure

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Belfast Health and Social Care Trust:

Primary Outcome Measures:
  • Left Ventricular Ejection Fraction [ Time Frame: 1 Year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cardiac Volumes [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
  • Levels of Inflammation [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Levels of Oxidative Stress [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Biomarkers of Cardiac Function [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Physical Functioning [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 79
Study Start Date: February 2009
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  • LVEF 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01005303

Locations
United Kingdom
Royal Victoria Hospital
Belfast, United Kingdom, BT12 6BA
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Dr Pascal McKeown, Belfast Health and Social Care Trust
ClinicalTrials.gov Identifier: NCT01005303     History of Changes
Other Study ID Numbers: RGHT000395
Study First Received: October 29, 2009
Last Updated: June 21, 2011
Health Authority: United Kingdom: National Health Service

Keywords provided by Belfast Health and Social Care Trust:
Heart Failure
Micronutrients
Vitamin D
Inflammation
 Oxidative Stress
Quality of Life
Physical Functioning

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
 Micronutrients
Trace Elements
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on May 16, 2013