| Trial ID: | L1670 |
| Source ID: | NCT00752401
|
| Associated Drug: |
Cholecalciferol
|
| Title: |
Vitamin D3 Substitution in Vitamin D Deficient Kidney Transplant Recipients
|
| Acronym: |
VITA-D
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Kidney Transplantation|Vitamin D Deficiency|Renal Osteodystrophy
|
| Interventions: |
DRUG: Cholecalciferol|DRUG: Placebo
|
| Outcome Measures: |
Primary: The immunologic effects of Vitamin D3 substitution in vitamin D deficient kidney transplant recipients will be evaluated by means of: Glomerular filtration rate, one year after kidney transplantation|Number of acute rejection episodes, one year after kidney transplantation|Number of infections, one year after kidney transplantation|CRP levels, one year after kidney transplantation|Courses of calcium levels, within the first year after kidney transplantation | Secondary: The impact of Vitamin D3 substitution on renal osteopathy will be analyzed by means of absolute bone mineral density (g/cm2), within the first year after kidney transplantation
|
| Sponsor/Collaborators: |
Sponsor: Medical University of Vienna
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
200
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2009-05
|
| Completion Date: |
2014-07
|
| Results First Posted: |
|
| Last Update Posted: |
2014-01-22
|
| Locations: |
Medical University of Vienna, Department of Internal Medicine III, Division of Nephrology and Dialysis, Vienna, Austria
|
| URL: |
https://clinicaltrials.gov/show/NCT00752401
|