Clinical trial NCT01005303: Micronutrient Supplementation in Patients With Heart Failure
Official title: A Trial of Micronutrient Supplementation in Patients With Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Heart Failure
Keywords: Heart Failure
Micronutrients
Vitamin D
Inflammation
Oxidative Stress
Quality of Life
Physical Functioning
Lead sponsor: Belfast Health and Social Care Trust
Sponsor class: OTHER
First posted: 2009-10-30
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Left Ventricular Ejection Fraction
timeFrame: Baseline, and 12 months
Secondary outcomes:
measure: Quality of Life Questionnaire Score
timeFrame: Baseline, and 12 months
measure: Six Minute Walk Test Distance
timeFrame: Baseline, and 12 months
measure: Serum N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) Concentration
timeFrame: Baseline, and 12 months
measure: Serum C-reactive Protein (CRP) Concentration
timeFrame: Baseline, and 12 months
measure: Serum Tumor Necrosis Factor-alpha (TNF-α) Concentration
timeFrame: Baseline, and 12 months
measure: Serum Interleukin-6 (IL-6) Concentration
timeFrame: Baseline, and 12 months
measure: Serum Interleukin-10 (IL-10) Concentration
timeFrame: Baseline, and 12 months
measure: Urinary 8-iso-prostaglandin F2 Alpha (8-iso-PGF2α) Concentration
timeFrame: Baseline, and 12 months
Other outcomes:
Locations:
city: Belfast
country: United Kingdom
facility: Royal Victoria Hospital
Study officials:
affiliation: Belfast Health and Social Care Trust
name: Pascal McKeown, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Belfast Health and Socail Care Trust
name: Mark Harbinson, MD
role: STUDY_DIRECTOR
affiliation: The Queen's Univeristy of Belfast
name: Michelle McKinley, PhD
role: STUDY_DIRECTOR
References:
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.