Evaluation of Colecalciferol Substitution in Dialysis Patients

May 26, 2015 updated by: University Hospital, Saarland
The purpose of this study is to determine the effect of a colecalciferol substitution in dialysis patients on bone metabolism and immune system

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Saarland
      • Homburg, Saarland, Germany, 66421
        • University Hospital of Saarland, Dpt. of Internal Medicine IV, Div. of Nephrology and Hypertension

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
CD14/CD16-Monocyte-Subsets (Frequency)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Saarland

Investigators

  • Principal Investigator: Eric Seibert, M.D., University Hospital of Saarland, Dpt. of Internal Medicine IV, Div. of Nephrology and Hypertension

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

November 7, 2006

First Submitted That Met QC Criteria

November 7, 2006

First Posted (Estimate)

November 9, 2006

Study Record Updates

Last Update Posted (Estimate)

May 27, 2015

Last Update Submitted That Met QC Criteria

May 26, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 142/06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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