Skip to main content
OpenTrials
Completed

NCT Number: NCT00397475

Evaluation of Colecalciferol Substitution in Dialysis Patients

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Renal Insufficiency, Chronic Chronic Disease Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hyperparathyroidism Hyperparathyroidism, Secondary Kidney Diseases Male Urogenital Diseases Parathyroid Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Saarland, Dpt. of Internal Medicine IV, Div. of Nephrology and Hypertension

Homburg, Saarland, 66421, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Colecalciferol

Drug

Primary outcomes

  1. CD14/CD16-Monocyte-Subsets (Frequency)

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Saarland

Other

Registry information

Important dates

Study start
2006
Study completion
2007
First posted
Nov 9, 2006
Registry last updated
May 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.