Vitamin D3 Substitution in Vitamin D Deficient Kidney Transplant Recipients

Vitamin D Deficiency Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00752401
• Other study ID #: VitaD-1
• Secondary ID: EudraCT Number 2
• Status: Active, not recruiting
• Phase: Phase 3
• First received: September 11, 2008
• Last updated: January 20, 2014
• Start date: May 2009
• Est. completion date: July 2014

Study information

• Verified date: January 2014
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Office for Safety in Health Care
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Transplantation
• Renal Osteodystrophy
• Vitamin D Deficiency

Intervention

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.
• 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.

Locations

Country	Name	City	State
Austria	Medical University of Vienna, Department of Internal Medicine III, Division of Nephrology and Dialysis	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	No
Primary	Number of acute rejection episodes		one year after kidney transplantation	No
Primary	Number of infections		one year after kidney transplantation	No
Primary	CRP levels		one year after kidney transplantation	No
Primary	Courses of calcium levels		within the first year after kidney transplantation	Yes
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	No