Vitamin D og kronisk nyreinsufficiens
- Conditions
- Investigating the effects of treatment with not activated vitamin D (cholecalciferol) in chronic kidney disease petients with vitamin D deficiency.
- Registration Number
- EUCTR2008-006438-82-DK
- Lead Sponsor
- Odense Universitetshospital, Nyremedicinsk Afd. Y
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 120
- Chronic kidney disease (CKD 3-5 and renal transplanted patients)
- Age > 18 years
- Vitamin D insufficiency or deficiency (25-OHD < 50nmol/l, 3 months before project start)
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
- Treatment with vitamin D2/D3 (dose more than 10000 IU within the last 3 months)
- hypercalcæmi (Ca-ion > 1.35 mmol/L) more than 4 weeks despite missing intake of calcium containing preparations and aktivated vitamin D
- uncontrolled hyperphosphatæmia (S-phosphat > 2.2 mmol/L
- Sarcoidose
- Malignant disease
- psychotic disorders
- Pregnancy and lactation
- Allergy to soya
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Purpose of the experiment is to investigate the effect of treatment with not activated vitamin D (cholecalciferol) compared with placebo in a trial including chronic kidney disease patients with vitamin D deficiency. Multible biological variables are monitored in order to assess any effect on the biological system (calcium-phosphat metabolism, bone and endotel markers, inflammation and muscle function);Secondary Objective: ;Primary end point(s): - Calcium phosphate associated metabolites<br>- Bone markers<br>- Endotel markers<br>- Inflammation<br>- Muscle function
- Secondary Outcome Measures
Name Time Method