Prospective, placebo-controlled trial of vitamin D supplementation in patients with low-levels of 25-OH vitamin D to evaluate changes in markers of cardiovascular risk
Phase 1
- Conditions
- low levels of 25-OH vitamin D
- Registration Number
- EUCTR2007-007474-33-AT
- Lead Sponsor
- Dr. Harald Dobnig, Medizinische Univ. Klinik Graz, Abteilung für Endokrinologie und Nuklearmedizin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
25(OH)D level <20 ng/ml
age between 45 and 75 years
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
Heart failure > NYHA II
previous cardiovascular events
Serum Creatinine > 1.5 mg/dl
AST / ALT > 3x ULN
diabetes mellitus
uncontrolled hypertension (RR>160/100, either or)
new onset of statins or ACE-I or ARBs (within the last 2 month)
hypercalcaemia
urolithiasis
major psychiatric disorder
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method