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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
79
1 Tablet Daily
Forceval: 1 Tablet Daily; Vitamin D3: 2 Tablets Daily
Royal Victoria Hospital
Belfast, United Kingdom
Left Ventricular Ejection Fraction
Time frame: Baseline, and 12 months
Quality of Life Questionnaire Score
Minnesota Living With Heart Failure Questionnaire. The questionnaire is comprised of 21 questions around several physical, emotional and socioeconomic ways heart failure can adversely affect a patient's life. After receiving brief standardized instructions, the patient marks a 0 (zero) to 5 (five) scale to indicate the extent to which each itemized adversity of heart failure has prevented the patient from living as they wanted to live during the past 4 weeks. The questionnaire is simply scored by summation of all 21 responses (score range 0-105). Higher scores indicate worse quality of life.
Time frame: Baseline, and 12 months
Six Minute Walk Test Distance
Time frame: Baseline, and 12 months
Serum N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) Concentration
Time frame: Baseline, and 12 months
Serum C-reactive Protein (CRP) Concentration
Time frame: Baseline, and 12 months
Serum Tumor Necrosis Factor-alpha (TNF-α) Concentration
Time frame: Baseline, and 12 months
Serum Interleukin-6 (IL-6) Concentration
Time frame: Baseline, and 12 months
Serum Interleukin-10 (IL-10) Concentration
Time frame: Baseline, and 12 months
Urinary 8-iso-prostaglandin F2 Alpha (8-iso-PGF2α) Concentration
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Time frame: Baseline, and 12 months