Vitamin D3 Substitution in Vitamin D Deficient Kidney Transplant Recipients (VITA-D)

Medical University of Vienna

Status and phase

Unknown

Phase 3

Conditions

Renal Osteodystrophy

Kidney Transplantation

Vitamin D Deficiency

Treatments

Drug: Placebo

Drug: Cholecalciferol

Study type

Interventional

Funder types

Other

Identifiers

NCT00752401

EudraCT Number 2008-002807-21

VitaD-1

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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