Status:
COMPLETED
Vitamin D and Chronic Renal Insufficiency
Lead Sponsor:
Odense University Hospital
Conditions:
Vitamin D Deficiency
Chronic Renal Insufficiency
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Purpose of this study is to investigate the effect of treatment with vitamin D3 (cholecalciferol) compared with placebo in a trial including chronic kidney disease patients with vitamin D deficiency.
Detailed Description
Most patients with chronic renal insufficiency have vitamin D deficiency. It is still not common practice among nephrologists to monitor and correct vitamin D deficiency of chronic kidney disease (CKD...
Eligibility Criteria
Inclusion
- Chronic kidney disease (CKD 3-5 amd renal transplanted patients)
- Age \> 18 years
- Vitamin D insufficiency or deficiency (25-OHD \< 50 nmol/l, 3 months before project start)
Exclusion
- Treatment with vitamin D2/D3 (dose more than 10000 IU within the last 3 months)
- Hypercalcaemia (ca++ \> 1,35 mmol/l more than 4 weeks despite missing intake of calcium containing preparations and activated vitamin D)
- Uncontrolled hyperphosphataemia (s-phosphate \> 2,2 mmol/l)
- Sarcoidosis
- Malignant disease
- Psychotic disorders
- Pregnancy and lactation women
- Allergy to soya and peanut
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00968877
Start Date
September 1 2009
End Date
January 1 2011
Last Update
January 26 2011
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