Evaluation of Colecalciferol Substitution in Dialysis Patients

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00397475

Enrollment

Registered

2006-11-09

Start date

2006-11-30

Completion date

2007-03-31

Last updated

2015-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

RENAL INSUFFICIENCY, CHRONIC, Hyperparathyroidism, Secondary

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

Interventions

DRUGColecalciferol

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
CD14/CD16-Monocyte-Subsets (Frequency)	—

Secondary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026