Evaluation of Colecalciferol Substitution in Dialysis Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2007-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Cholecalciferol Versus Doxercalciferol in the Treatment of Secondary Hyperparathyroidism in Chronic Kidney Disease

NCT00285467

Renal Osteodystrophy

COMPLETED NA

Treatment of Secondary Hyperparathyroidism in the Uremic Patient

NCT00469599

Secondary Hyperparathyroidism Chronic Kidney Disease Vitamin D Deficiency

TERMINATED NA

Cholecalciferol on Hemodialysis Patients

NCT03602430

Hemodialysis Complication Vitamin D Deficiency Vascular Calcification

COMPLETED PHASE2/PHASE3

Vitamin D Deficiency in Chronic Kidney Disease (CKD) Patients

NCT00958451

Secondary Hyperparathyroidism Chronic Kidney Disease

COMPLETED PHASE4

Effects of Cholecalciferol on Osteoprotegerin Levels in Patients on Peritoneal Dialysis

NCT02598635

Vitamin D Deficiency Vascular Calcification Renal Insufficiency +1 more

UNKNOWN PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

RENAL INSUFFICIENCY, CHRONIC Hyperparathyroidism, Secondary

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Colecalciferol

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No