Vitamin D3 Substitution in Vitamin D Deficient Kidney Transplant Recipients (VITA-D)
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Purpose
The purpose of the study is to evaluate the effects of Cholecalciferol (Vitamin D3) substitution on the posttransplant outcome (glomerular filtration rate as well as serum creatinine levels, number of acute rejection episodes, number of infections and C-reactive protein levels within the first year after transplantation) in vitamin D deficient kidney transplant recipients.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Transplantation Vitamin D Deficiency Renal Osteodystrophy |
Drug: Cholecalciferol Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
- Number of acute rejection episodes [ Time Frame: one year after kidney transplantation ] [ Designated as safety issue: No ]
- Number of infections [ Time Frame: one year after kidney transplantation ] [ Designated as safety issue: No ]
- CRP levels [ Time Frame: one year after kidney transplantation ] [ Designated as safety issue: No ]
- Courses of calcium levels [ Time Frame: within the first year after kidney transplantation ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 200 |
| Study Start Date: | May 2009 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
6800 IU/day of Cholecalciferol (Vitamin D3) orally for one year
|
Drug: Cholecalciferol
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.
Other Names:
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|
Placebo Comparator: 2
Oral placebo solution daily for one year
|
Drug: Placebo
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.
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Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- age > 18
- deceased donor kidney transplant recipients
- only kidney transplant recipients
- vitamin D deficiency defined as 25 (OH)D < 50nmol/l
Exclusion Criteria:
- re-transplantation for the second time if the patient is highly immunized and therefore included in the aphaeresis program
- re-transplantation for the third or further time
- significant impaired intestinal resorption: malabsorption due to celiac sprue, systemic scleroderma; maldigestion due to chronic pancreatitis, pancreatic insufficiency, pancreas resection, mucoviscidosis, Zollinger-Ellison-syndrome
- history of inflammatory bowel disease: Crohn's disease, ulcerative colitis
- previous gastrectomy, small bowel or large bowel resection, intestinal bypass surgery
- severe liver disease: cirrhosis
- HIV positive
Contacts and Locations| Contact: Kyra Borchhardt, MD | 0043140400 ext 4217 | kyra.borchhardt@meduniwien.ac.at |
| Austria | |
| Medical University of Vienna, Department of Internal Medicine III, Division of Nephrology and Dialysis | Recruiting |
| Vienna, Austria | |
| Contact: Kyra Borchhardt, MD kyra.borchhardt@meduniwien.ac.at | |
| Principal Investigator: | Kyra Borchhardt, MD | Medical University of Vienna, Department of Internal Medicine III, Division of Nephrology and Dialysis |
More Information
No publications provided by Medical University of Vienna
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Kyra Borchhardt, MD, Medical University of Vienna, Department of Internal Medicine III, Division of Nephrology and Dialysis |
| ClinicalTrials.gov Identifier: | NCT00752401 History of Changes |
| Other Study ID Numbers: | VitaD-1, EudraCT Number 2008-002807-21 |
| Study First Received: | September 11, 2008 |
| Last Updated: | May 8, 2009 |
| Health Authority: | Austria: Federal Office for Safety in Health Care |
Keywords provided by Medical University of Vienna:
|
Vitamin D Vitamin D3 Vitamin D deficiency Cholecalciferol 25-hydroxyvitamin D3 Immunomodulation |
Kidney transplantation Renal transplantation Graft function Acute rejection Renal osteodystrophy Posttransplant bone loss |
Additional relevant MeSH terms:
|
Vitamin D Deficiency Renal Osteodystrophy Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Rickets Kidney Diseases Urologic Diseases Calcium Metabolism Disorders Metabolic Diseases Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders |
Hyperparathyroidism, Secondary Hyperparathyroidism Parathyroid Diseases Endocrine System Diseases Cholecalciferol Vitamin D Ergocalciferols Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Bone Density Conservation Agents |
ClinicalTrials.gov processed this record on May 21, 2013