Status:
COMPLETED
Evaluation of Colecalciferol Substitution in Dialysis Patients
Lead Sponsor:
University Hospital, Saarland
Conditions:
RENAL INSUFFICIENCY, CHRONIC
Hyperparathyroidism, Secondary
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to determine the effect of a colecalciferol substitution in dialysis patients on bone metabolism and immune system
Eligibility Criteria
Inclusion
- Serum 25-OH-Vit.D-levels \< 60 ng/ml
- Age \> 18 years
- dialysis treatment \> 3 Months
- signed written informed consent
- Serum-Calcium-levels \< 2,6 mmol/l within the last 4 weeks
- Serum-Phosphate-levels \< 7,0 mg/dl within the last 4 weeks
- Ca x P-Product \< 75 mg2/dl2 within the last 4 weeks
Exclusion
- Serum 25-OH-Vit.-D-levels \> 60 ng/ml
- concommitant participation in another interventional trial
- psychiatric disorders preventing from valid informed consent
- Hyperphosphatemia (\> 7,0 mg/dl) within the last 4 weeks
- Hypercalcemia (\> 2,6 mmol/l) within the last 4 weeks
- Ca x P-Product \> 75 mg2/dl2 within the last 4 weeks
- pregnancy or lactation
- known malignancy
- liver disease, defined as 2-fold upper limit of ASAT-, or ALAT-levels
- PTH levels \< 50 pg/ml
- current clinically relevant infections treated with antibiotic therapy and raised hsCRP levels
- Chronic viral Infectious diseases (e.g. HIV, Hepatitis B or C)
- Immunosuppressant Medication
- known hematologic disorders, other than renal anemia
- age below 18 years
- known anaphylactic reaction against the study medication or other ingredients of the study drug preparation
- renal calculus
- Pseudohypoparathyroidism
- Medication including cardiac glycosides
- Sarkoidosis
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2007
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00397475
Start Date
November 1 2006
End Date
March 1 2007
Last Update
May 27 2015
Active Locations (1)
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1
University Hospital of Saarland, Dpt. of Internal Medicine IV, Div. of Nephrology and Hypertension
Homburg, Saarland, Germany, 66421