This trial is active, not recruiting.

Condition heart failure
Treatments placebo, forceval plus 50 micrograms vitamin d3
Phase phase 2/phase 3
Sponsor Belfast Health and Social Care Trust
Start date February 2009
End date August 2013
Trial size 79 participants
Trial identifier NCT01005303, RGHT000395


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
(Placebo Comparator)
1 Tablet Daily
(Active Comparator)
forceval plus 50 micrograms vitamin d3
Forceval: 1 Tablet Daily; Vitamin D3: 2 Tablets Daily

Primary Outcomes

Left Ventricular Ejection Fraction
time frame: 1 Year

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title A Trial of Micronutrient Supplementation in Patients With Heart Failure
Principal investigator Pascal McKeown, MD
Trial information was received from ClinicalTrials.gov and was last updated in January 2015.
Information provided to ClinicalTrials.gov by Belfast Health and Social Care Trust.