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

Primary Purpose

Heart Failure

Status
Unknown status
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Placebo
Forceval plus 50 micrograms Vitamin D3
Sponsored by
Belfast Health and Social Care Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart Failure, Micronutrients, Vitamin D, Inflammation, Oxidative Stress, Quality of Life, Physical Functioning

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Royal Victoria Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Micronutrient

Arm Description

Outcomes

Primary Outcome Measures

Left Ventricular Ejection Fraction

Secondary Outcome Measures

Cardiac Volumes
Levels of Inflammation
Levels of Oxidative Stress
Biomarkers of Cardiac Function
Quality of Life
Physical Functioning

Full Information

First Posted
October 29, 2009
Last Updated
January 27, 2015
Sponsor
Belfast Health and Social Care Trust
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1. Study Identification

Unique Protocol Identification Number
NCT01005303
Brief Title
Micronutrient Supplementation in Patients With Heart Failure
Acronym
MINT-HF
Official Title
A Trial of Micronutrient Supplementation in Patients With Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2009 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
July 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Belfast Health and Social Care Trust

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart Failure, Micronutrients, Vitamin D, Inflammation, Oxidative Stress, Quality of Life, Physical Functioning

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Micronutrient
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
1 Tablet Daily
Intervention Type
Drug
Intervention Name(s)
Forceval plus 50 micrograms Vitamin D3
Intervention Description
Forceval: 1 Tablet Daily; Vitamin D3: 2 Tablets Daily
Primary Outcome Measure Information:
Title
Left Ventricular Ejection Fraction
Time Frame
1 Year
Secondary Outcome Measure Information:
Title
Cardiac Volumes
Time Frame
1 Year
Title
Levels of Inflammation
Time Frame
6 and 12 months
Title
Levels of Oxidative Stress
Time Frame
6 and 12 months
Title
Biomarkers of Cardiac Function
Time Frame
6 and 12 months
Title
Quality of Life
Time Frame
1 year
Title
Physical Functioning
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pascal McKeown, MD
Organizational Affiliation
Belfast Health and Social Care Trust
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark Harbinson, MD
Organizational Affiliation
Belfast Health and Socail Care Trust
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Michelle McKinley, PhD
Organizational Affiliation
The Queen's Univeristy of Belfast
Official's Role
Study Director
Facility Information:
Facility Name
Royal Victoria Hospital
City
Belfast
ZIP/Postal Code
BT12 6BA
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
24952700
Citation
McKeag NA, McKinley MC, Harbinson MT, Noad RL, Dixon LH, McGinty A, Neville CE, Woodside JV, McKeown PP. The effect of multiple micronutrient supplementation on left ventricular ejection fraction in patients with chronic stable heart failure: a randomized, placebo-controlled trial. JACC Heart Fail. 2014 Jun;2(3):308-17. doi: 10.1016/j.jchf.2013.12.008. Erratum In: JACC Heart Fail. 2014 Oct;2(5):549.
Results Reference
derived

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Micronutrient Supplementation in Patients With Heart Failure

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