Vitamin D3 Substitution in Vitamin D Deficient Kidney Transplant Recipients (VITA-D)
Primary Purpose
Kidney Transplantation, Vitamin D Deficiency, Renal Osteodystrophy
Status
Unknown status
Phase
Phase 3
Locations
Austria
Study Type
Interventional
Intervention
Cholecalciferol
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Kidney Transplantation focused on measuring Vitamin D, Cholecalciferol, Vitamin D3, 25-hydroxyvitamin D3, Immunomodulation, Vitamin D deficiency, Kidney transplantation, Renal transplantation, Graft function, Acute rejection, Renal osteodystrophy, Posttransplant bone loss
Eligibility Criteria
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
Sites / Locations
- Medical University of Vienna, Department of Internal Medicine III, Division of Nephrology and Dialysis
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
6800 IU/day of Cholecalciferol (Vitamin D3) orally for one year
Oral placebo solution daily for one year
Outcomes
Primary Outcome Measures
The immunologic effects of Vitamin D3 substitution in vitamin D deficient kidney transplant recipients will be evaluated by means of: Glomerular filtration rate
Number of acute rejection episodes
Number of infections
CRP levels
Courses of calcium levels
Secondary Outcome Measures
The impact of Vitamin D3 substitution on renal osteopathy will be analyzed by means of absolute bone mineral density (g/cm2)
Full Information
NCT ID
NCT00752401
First Posted
September 11, 2008
Last Updated
January 20, 2014
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT00752401
Brief Title
Vitamin D3 Substitution in Vitamin D Deficient Kidney Transplant Recipients
Acronym
VITA-D
Official Title
VITA-D: Cholecalciferol Substitution in Vitamin D Deficient Kidney Transplant Recipients: A Randomized, Placebo-controlled Study to Evaluate the Posttransplant Outcome
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
May 2009 (undefined)
Primary Completion Date
July 2014 (Anticipated)
Study Completion Date
July 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Transplantation, Vitamin D Deficiency, Renal Osteodystrophy
Keywords
Vitamin D, Cholecalciferol, Vitamin D3, 25-hydroxyvitamin D3, Immunomodulation, Vitamin D deficiency, Kidney transplantation, Renal transplantation, Graft function, Acute rejection, Renal osteodystrophy, Posttransplant bone loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
6800 IU/day of Cholecalciferol (Vitamin D3) orally for one year
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Oral placebo solution daily for one year
Intervention Type
Drug
Intervention Name(s)
Cholecalciferol
Other Intervention Name(s)
Vitamin D3, Oleovit® D3
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Title
Number of acute rejection episodes
Time Frame
one year after kidney transplantation
Title
Number of infections
Time Frame
one year after kidney transplantation
Title
CRP levels
Time Frame
one year after kidney transplantation
Title
Courses of calcium levels
Time Frame
within the first year after kidney transplantation
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyra Borchhardt, MD
Organizational Affiliation
Medical University of Vienna, Department of Internal Medicine III, Division of Nephrology and Dialysis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Vienna, Department of Internal Medicine III, Division of Nephrology and Dialysis
City
Vienna
Country
Austria
12. IPD Sharing Statement
Citations:
PubMed Identifier
19480654
Citation
Thiem U, Heinze G, Segel R, Perkmann T, Kainberger F, Muhlbacher F, Horl W, Borchhardt K. VITA-D: cholecalciferol substitution in vitamin D deficient kidney transplant recipients: a randomized, placebo-controlled study to evaluate the post-transplant outcome. Trials. 2009 May 29;10:36. doi: 10.1186/1745-6215-10-36.
Results Reference
derived
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Vitamin D3 Substitution in Vitamin D Deficient Kidney Transplant Recipients
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