Vitamin D supplementation in chronic heart failure: a randomized, double-blind, placebo-controlled trial
- Conditions
- Chronic stable heart failure (NYHA II-IV, ejection fraction = 40%)Vitamin D deficiency (defined as 25 (OH) Vitamin D = 30ng/ml)
- Registration Number
- EUCTR2010-022763-35-AT
- Lead Sponsor
- Medical University of Graz
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
•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
•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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br>-Serum calcium, phosphorus, 25(OH)D, 1,25(OH)D, PTH, osteocalcin, renin, aldosterone, OPG and RANKL, urinary calcium<br>-Frozen serum/plasma for potential other analysis (eg. TNFa, IL 6, IL 10)<br>-Overall mortality at 6 months<br>-number and duration of hospital admissions for acute heart failure<br>-number of infectious complications requiring antibiotics<br>-falls/fractures<br>-corrected QT time in ECG<br>-blood pressure<br>-DXA including body composition at month 0 and 6 or 12<br>;Primary end point(s): -Change of NT-proBNP levels ;Timepoint(s) of evaluation of this end point: month 0 and 6
- Secondary Outcome Measures
Name Time Method Secondary end point(s): -Percentage of patients with 25(OH)D = 30 ng/ml at month 6<br>-Serum calcium, phosphorus, 25(OH)D, 1,25(OH)D , PTH, osteocalcin, renin, aldosterone, OPG and RANKL, urinary calcium<br>-Frozen serum/plasma for potential other analysis (eg. TNFa, IL 6, IL 10)<br>-Overall mortality at 6 months<br>-number and duration of hospital admissions for acute heart failure<br>-number of infectious complications requiring antibiotics<br>-falls/fractures<br>-corrected QT time in ECG, blood pressure<br>-DXA including body composition at month 0 and 12<br>;Timepoint(s) of evaluation of this end point: months 0,6 and 12 (see specification above for each secondary end point)