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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
University Hospital, Saarland
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for RENAL INSUFFICIENCY, CHRONIC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

First Posted
November 7, 2006
Last Updated
May 26, 2015
Sponsor
University Hospital, Saarland
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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

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Evaluation of Colecalciferol Substitution in Dialysis Patients

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