Chronic stable heart failure (NYHA II-IV, ejection fraction = 40%) Vitamin D deficiency (defined as 25 (OH) Vitamin D = 30ng/ml)
Conditions
Interventions
Trade Name: Oleovit D3
Product Name: Oleovit D3
Pharmaceutical Form: Oral drops
Pharmaceutical form of the placebo: Oral drops
Route of administration of the placebo: Oral use
Sponsors
Medical University of Graz
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Chronic stable heart failure (NYHA II-IV, ejection fraction = 40%) • Non-ischemic etiology or ischemic etiology without severe advanced atherosclerosis (e.g. peripheral arterial disease stage IV) • = 45 years • 25 (OH) Vitamin D = 30ng/ml Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • hypercalcemia (total serum calcium > 2.65 mmol/l OR ionized calcium > 1.35 mmol/l) • nephrocalcinosis, nephro-/urolithiasis (=1 year) • known granulomatous diseases (active tuberculosis, sarcoidosis) • allergy to cholecalciferol or placebo (oleum arachidis) • intake of magnesium, thiazide diuretics or cardiac glycosides • osteoporosis requiring standard therapy • pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to investigate whether vitamin D-supplementation leads to a significant reduction of NT-proBNP levels at month 6.;Secondary Objective: - Percentage of patients with 25(OH)D = 30 ng/ml at month 6 - Serum calcium, phosphorus, 25(OH)D, 1,25(OH)D, PTH, osteocalcin, renin, aldosterone, OPG and RANKL, urinary calcium - Frozen serum/plasma for potential other analysis (eg. TNFa, IL 6, IL 10) - Overall mortality at 6 months - number and duration of hospital admissions for acute heart failure - number of infectious complications requiring antibiotics - falls/fractures - corrected QT time in ECG - blood pressure - DXA including body composition at month 0 and 6 or 12 ;Primary end point(s): - Change of NT-proBNP levels ;Timepoint(s) of evaluation of this end point: month 0 and 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Percentage of patients with 25(OH)D = 30 ng/ml at month 6 - Serum calcium, phosphorus, 25(OH)D, 1,25(OH)D , PTH, osteocalcin, renin, aldosterone, OPG and RANKL, urinary calcium - Frozen serum/plasma for potential other analysis (eg. TNFa, IL 6, IL 10) - Overall mortality at 6 months - number and duration of hospital admissions for acute heart failure - number of infectious complications requiring antibiotics - falls/fractures - corrected QT time in ECG, blood pressure - DXA including body composition at month 0 and 12 ;Timepoint(s) of evaluation of this end point: months 0,6 and 12 (see specification above for each secondary end point) | — |
Countries
Austria
Outcome results
None listed