Evaluation of Colecalciferol Substitution in Dialysis Patients

RENAL INSUFFICIENCY, CHRONIC Clinical Trial

Official title:

Evaluation of Colecalciferol Substitution in Dialysis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00397475
• Other study ID #: 142/06
• Status: Completed
• Phase: N/A
• First received: November 7, 2006
• Last updated: May 26, 2015
• Start date: November 2006
• Est. completion date: March 2007

Study information

• Verified date: May 2015
• Source: University Hospital, Saarland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Drug:
• Colecalciferol

Locations

Country	Name	City	State
Germany	University Hospital of Saarland, Dpt. of Internal Medicine IV, Div. of Nephrology and Hypertension	Homburg	Saarland

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Saarland

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CD14/CD16-Monocyte-Subsets (Frequency)
Secondary	Production of Cytokines: IFN-?, TNF-a
Secondary	Serum levels of Calcium, Phosphorus, iPTH, hsCRP, alkaline phosphatase
Secondary	Th1/Th2- and Tc1/Tc2-Lymphocyte-Frequency