Evaluation of Colecalciferol Substitution in Dialysis Patients

Not Applicable

Completed

• Conditions: RENAL INSUFFICIENCY, CHRONIC; Hyperparathyroidism, Secondary

• Registration Number: NCT00397475
• Lead Sponsor: University Hospital, Saarland

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2006-11-07
• Study First Submitted QC: 2006-11-07
• Study First Posted: 2006-11-09
• Study Completion: 2007-03
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-26
• Last Update Posted: 2015-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Serum 25-OH-Vit.D-levels < 60 ng/ml
2. Age > 18 years
3. dialysis treatment > 3 Months
4. signed written informed consent
5. Serum-Calcium-levels < 2,6 mmol/l within the last 4 weeks
6. Serum-Phosphate-levels < 7,0 mg/dl within the last 4 weeks
7. Ca x P-Product < 75 mg2/dl2 within the last 4 weeks

Exclusion Criteria

1. Serum 25-OH-Vit.-D-levels > 60 ng/ml
2. concommitant participation in another interventional trial
3. psychiatric disorders preventing from valid informed consent
4. Hyperphosphatemia (> 7,0 mg/dl) within the last 4 weeks
5. Hypercalcemia (> 2,6 mmol/l) within the last 4 weeks
6. Ca x P-Product > 75 mg2/dl2 within the last 4 weeks
7. pregnancy or lactation
8. known malignancy
9. liver disease, defined as 2-fold upper limit of ASAT-, or ALAT-levels
10. PTH levels < 50 pg/ml
11. current clinically relevant infections treated with antibiotic therapy and raised hsCRP levels
12. Chronic viral Infectious diseases (e.g. HIV, Hepatitis B or C)
13. Immunosuppressant Medication
14. known hematologic disorders, other than renal anemia
15. age below 18 years
16. known anaphylactic reaction against the study medication or other ingredients of the study drug preparation
17. renal calculus
18. Pseudohypoparathyroidism
19. Medication including cardiac glycosides
20. Sarkoidosis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
CD14/CD16-Monocyte-Subsets (Frequency)

Secondary Outcome Measures

Name	Time	Method
Production of Cytokines: IFN-γ, TNF-α
Serum levels of Calcium, Phosphorus, iPTH, hsCRP, alkaline phosphatase
Th1/Th2- and Tc1/Tc2-Lymphocyte-Frequency

Trial Locations

Locations (1)

University Hospital of Saarland, Dpt. of Internal Medicine IV, Div. of Nephrology and Hypertension; 🇩🇪 Homburg, Saarland, Germany