Evaluation of Colecalciferol Substitution in Dialysis Patients

• Status: Completed
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the effect of a colecalciferol substitution in dialysis patients on bone metabolism and immune system

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Saarland
• Treatments: Cholecalciferol

Criteria

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