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Evaluation of Colecalciferol Substitution in Dialysis Patients

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ClinicalTrials.gov Identifier: NCT00397475
Recruitment Status : Completed
First Posted : November 9, 2006
Last Update Posted : May 27, 2015
Sponsor:
Information provided by:
University Hospital, Saarland

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

Condition or disease Intervention/treatment Phase
RENAL INSUFFICIENCY, CHRONIC Hyperparathyroidism, Secondary Drug: Colecalciferol Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Evaluation of Colecalciferol Substitution in Dialysis Patients
Study Start Date : November 2006
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. CD14/CD16-Monocyte-Subsets (Frequency)

Secondary Outcome Measures :
  1. Production of Cytokines: IFN-γ, TNF-α
  2. Serum levels of Calcium, Phosphorus, iPTH, hsCRP, alkaline phosphatase
  3. Th1/Th2- and Tc1/Tc2-Lymphocyte-Frequency


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00397475     History of Changes
Other Study ID Numbers: 142/06
First Posted: November 9, 2006    Key Record Dates
Last Update Posted: May 27, 2015
Last Verified: May 2015

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