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Evaluation of Colecalciferol Substitution in Dialysis Patients

This study has been completed.
Information provided by:
University Hospital, Saarland Identifier:
First received: November 7, 2006
Last updated: May 26, 2015
Last verified: May 2015
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
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:

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00397475

University Hospital of Saarland, Dpt. of Internal Medicine IV, Div. of Nephrology and Hypertension
Homburg, Saarland, Germany, 66421
Sponsors and Collaborators
University Hospital, Saarland
Principal Investigator: Eric Seibert, M.D. University Hospital of Saarland, Dpt. of Internal Medicine IV, Div. of Nephrology and Hypertension
  More Information Identifier: NCT00397475     History of Changes
Other Study ID Numbers: 142/06
Study First Received: November 7, 2006
Last Updated: May 26, 2015

Additional relevant MeSH terms:
Renal Insufficiency
Renal Insufficiency, Chronic
Hyperparathyroidism, Secondary
Kidney Diseases
Urologic Diseases
Parathyroid Diseases
Endocrine System Diseases
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents processed this record on May 25, 2017