MINT-HF: Micronutrient Supplementation in Patients With Heart Failure

Sponsor

Belfast Health and Social Care Trust (Other)

Overall Status

Unknown status

CT.gov ID

NCT01005303

Collaborator

(none)

Enrollment

Location

Arms

76.9

Duration (Months)

Patients Per Site Per Month

Study Details

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.

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

Study Design

Study Type:

Interventional

Actual Enrollment :

79 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Trial of Micronutrient Supplementation in Patients With Heart Failure

Study Start Date :

Feb 1, 2009

Actual Primary Completion Date :

Aug 1, 2013

Anticipated Study Completion Date :

Jul 1, 2015

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Left Ventricular Ejection Fraction [1 Year]

Secondary Outcome Measures

Cardiac Volumes [1 Year]
Levels of Inflammation [6 and 12 months]
Levels of Oxidative Stress [6 and 12 months]
Biomarkers of Cardiac Function [6 and 12 months]
Quality of Life [1 year]
Physical Functioning [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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