Investigating the effects of treatment with not activated vitamin D (cholecalciferol) in chronic kidney disease petients with vitamin D deficiency.
Conditions
Interventions
Trade Name: Dekristol
Product Name: Cholecalciferol
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: CHOLECALCIFEROL
Concentration unit: IU international unit(s)
Pharmaceutical form of the plac
Sponsors
Odense Universitetshospital, Nyremedicinsk Afd. Y
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Chronic kidney disease (CKD 3-5 and renal transplanted patients) - Age > 18 years - Vitamin D insufficiency or deficiency (25-OHD =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 - Bone markers - Endotel markers - Inflammation - Muscle function | — |
Countries
Denmark
Outcome results
None listed