Phase 3 N=74 Randomized Double-blind Treatment

Micronutrient Supplementation in Patients With Heart Failure

Heart Failure

Bottom Line

View on ClinicalTrials.gov: NCT01005303 ↗

Enrolled (actual)

Serious AEs

37.8%

Results posted

Dec 2023

Primary outcome: Primary: Left Ventricular Ejection Fraction — 44.7; 38.9; 44.9; 38.6 percentage of LVEF

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Placebo (Drug); Forceval plus 50 micrograms Vitamin D3 (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Belfast Health and Social Care Trust
Primary completion: Aug 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Left Ventricular Ejection Fraction	44.7; 38.9; 44.9; 38.6	—
SECONDARY Quality of Life Questionnaire Score	33.7; 34.0; 38.2; 33.1	—
SECONDARY Six Minute Walk Test Distance	437.8; 417.0; 440.2; 412.5	—
SECONDARY Serum N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) Concentration	841.6; 1293.4; 1343.6; 1763.6	—
SECONDARY Serum C-reactive Protein (CRP) Concentration	5.6; 6.3; 4.3; 4.6	—
SECONDARY Serum Tumor Necrosis Factor-alpha (TNF-α) Concentration	4.4; 4.1; 4.6; 4.1	—
SECONDARY Serum Interleukin-6 (IL-6) Concentration	5.0; 7.1; 5.0; 4.2	—
SECONDARY Serum Interleukin-10 (IL-10) Concentration	1.5; 1.2; 1.5; 1.1	—
SECONDARY Urinary 8-iso-prostaglandin F2 Alpha (8-iso-PGF2α) Concentration	11.3; 12.1; 11.7; 10.5	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01005303). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.