Evaluation of Colecalciferol Substitution in Dialysis Patients
Primary Purpose
RENAL INSUFFICIENCY, CHRONIC, Hyperparathyroidism, Secondary
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Colecalciferol
Sponsored by
About this trial
This is an interventional treatment trial for RENAL INSUFFICIENCY, CHRONIC
Eligibility Criteria
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
Sites / Locations
- University Hospital of Saarland, Dpt. of Internal Medicine IV, Div. of Nephrology and Hypertension
Outcomes
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
Full Information
NCT ID
NCT00397475
First Posted
November 7, 2006
Last Updated
May 26, 2015
Sponsor
University Hospital, Saarland
1. Study Identification
Unique Protocol Identification Number
NCT00397475
Brief Title
Evaluation of Colecalciferol Substitution in Dialysis Patients
Official Title
Evaluation of Colecalciferol Substitution in Dialysis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Saarland
4. Oversight
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
RENAL INSUFFICIENCY, CHRONIC, Hyperparathyroidism, Secondary
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Colecalciferol
Primary Outcome Measure Information:
Title
CD14/CD16-Monocyte-Subsets (Frequency)
Secondary Outcome Measure Information:
Title
Production of Cytokines: IFN-γ, TNF-α
Title
Serum levels of Calcium, Phosphorus, iPTH, hsCRP, alkaline phosphatase
Title
Th1/Th2- and Tc1/Tc2-Lymphocyte-Frequency
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Seibert, M.D.
Organizational Affiliation
University Hospital of Saarland, Dpt. of Internal Medicine IV, Div. of Nephrology and Hypertension
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Saarland, Dpt. of Internal Medicine IV, Div. of Nephrology and Hypertension
City
Homburg
State/Province
Saarland
ZIP/Postal Code
66421
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Colecalciferol Substitution in Dialysis Patients
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