Vitamin D3 Substitution in Vitamin D Deficient Kidney Transplant Recipients (VITA-D)
Recruitment status was: Active, not recruiting
|Kidney Transplantation Vitamin D Deficiency Renal Osteodystrophy||Drug: Cholecalciferol Drug: Placebo||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||VITA-D: Cholecalciferol Substitution in Vitamin D Deficient Kidney Transplant Recipients: A Randomized, Placebo-controlled Study to Evaluate the Posttransplant Outcome|
- The immunologic effects of Vitamin D3 substitution in vitamin D deficient kidney transplant recipients will be evaluated by means of: Glomerular filtration rate [ Time Frame: one year after kidney transplantation ]
- Number of acute rejection episodes [ Time Frame: one year after kidney transplantation ]
- Number of infections [ Time Frame: one year after kidney transplantation ]
- CRP levels [ Time Frame: one year after kidney transplantation ]
- Courses of calcium levels [ Time Frame: within the first year after kidney transplantation ]
- The impact of Vitamin D3 substitution on renal osteopathy will be analyzed by means of absolute bone mineral density (g/cm2) [ Time Frame: within the first year after kidney transplantation ]
|Study Start Date:||May 2009|
|Estimated Study Completion Date:||July 2014|
|Estimated Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
Active Comparator: 1
6800 IU/day of Cholecalciferol (Vitamin D3) orally for one year
6800 IU of Cholecalciferol will be administered in the form of Oleovit® D3-drops once a day for one year. Treatment starts on day 5 after kidney transplantation. At serum calcium levels >2,65 mmol/l vitamin D3 administration will be reduced to 3600 IU per day. If calcium levels persist above 2,85 mmol/l over a period of four weeks vitamin D3 administration will be discontinued and restarted when serum calcium levels declined to ≤ 2,65 mmol/l with only 3600 International Units per day.
Placebo Comparator: 2
Oral placebo solution daily for one year
An oral placebo solution matching Cholecalciferol in terms of appearance, smell and taste will be administered once a day for one year. Treatment starts on day 5 after kidney transplantation.
Apart from its classical actions in calcium homeostasis, vitamin D acts as a potent immunomodulatory agent. As such, vitamin D is thought to have beneficial effects in the transplant setting, especially in kidney transplant recipients considering the fact that approximately 40% of all kidney transplant recipients are vitamin D deficient.
Therefore, the objective is to conduct a randomized, double-blind, placebo-controlled study focusing on the impact of Cholecalciferol substitution in vitamin D deficient kidney transplant recipients on graft function (glomerular filtration rate as well as serum creatinine levels), incidence of acute rejection episodes, frequency and severity (CRP levels) of posttransplant infections within the first year after kidney transplantation.
Moreover, the impact of Vitamin D3 on renal osteodystrophy will be analyzed by means of bone mineral density. DXA measurements will be performed during the first four weeks after kidney transplantation, after 5, and after 12 months posttransplant.
Kidney transplant recipients found to have vitamin D deficiency (defined as 25-hydroxyvitamin D < 50 nmol/l) will be included and will be randomized to receive either oral Vitamin D3 therapy or placebo. Vitamin D3 will be administered at a daily dose of 6800IU over a time period of one year.
All in all, 200 subjects will be included in the VITA-D study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00752401
|Medical University of Vienna, Department of Internal Medicine III, Division of Nephrology and Dialysis|
|Principal Investigator:||Kyra Borchhardt, MD||Medical University of Vienna, Department of Internal Medicine III, Division of Nephrology and Dialysis|