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Evaluation of Colecalciferol Substitution in Dialysis Patients

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Saarland
ClinicalTrials.gov Identifier:
NCT00397475
First received: November 7, 2006
Last updated: April 10, 2012
Last verified: April 2012
History of Changes
  Purpose

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


Condition Intervention
RENAL INSUFFICIENCY, CHRONIC
Hyperparathyroidism, Secondary
 Drug: Colecalciferol

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Evaluation of Colecalciferol Substitution in Dialysis Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Saarland:

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

Estimated Enrollment: 50
Study Start Date: November 2006
Study Completion Date: March 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00397475

Locations
Germany
University Hospital of Saarland, Dpt. of Internal Medicine IV, Div. of Nephrology and Hypertension
Homburg, Saarland, Germany, 66421
Sponsors and Collaborators
University Hospital, Saarland
Investigators
Principal Investigator: Eric Seibert, M.D. University Hospital of Saarland, Dpt. of Internal Medicine IV, Div. of Nephrology and Hypertension
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00397475     History of Changes
Other Study ID Numbers: 142/06
Study First Received: November 7, 2006
Last Updated: April 10, 2012
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Hyperparathyroidism
Hyperparathyroidism, Secondary
Renal Insufficiency
Renal Insufficiency, Chronic
Parathyroid Diseases
Endocrine System Diseases
Kidney Diseases
Urologic Diseases
 Cholecalciferol
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on May 16, 2013