Evaluation of Colecalciferol Substitution in Dialysis Patients

Sponsor

University Hospital, Saarland (Other)

Overall Status

Completed

CT.gov ID

NCT00397475

Collaborator

(none)

Enrollment

Location

3.9

Duration (Months)

12.7

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
RENAL INSUFFICIENCY, CHRONIC Hyperparathyroidism, Secondary	Drug: Colecalciferol	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

Evaluation of Colecalciferol Substitution in Dialysis Patients

Study Start Date :

Nov 1, 2006

Actual Study Completion Date :

Mar 1, 2007

Outcome Measures

Primary Outcome Measures

CD14/CD16-Monocyte-Subsets (Frequency) []

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 Criteria:

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