Phase 3
Completed N=74
Micronutrient Supplementation in Patients With Heart Failure
Source: ClinicalTrials.gov NCT01005303 ↗Enrolled (actual)
74
Serious AEs
37.8%
Results posted
Dec 2023
Primary outcomePrimary: Left Ventricular Ejection Fraction — 44.7; 38.9; 44.9; 38.6 percentage of LVEF
◆ Published Evidence
Established
32citations · ~3 / year
The effect of multiple micronutrient supplementation on left ventricular ejection fraction in patients with chronic stable heart failure: a randomized, placebo-controlled trial.
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.
Linked Publications
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The effect of multiple micronutrient supplementation on left ventricular ejection fraction in patients with chronic stable heart failure: a randomized, placebo-controlled trial.
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 | — |
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
Data sourced from ClinicalTrials.gov (NCT01005303) and the linked publication. 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. Informational only — not medical advice.