VITA-D: Cholecalciferol substitution in vitamin D deficient kidney transplant recipients: A randomized, placebo-controlled study to evaluate the posttransplant outcome - VITA-D

Phase 1

• Conditions: Vitamin D deficiency in kidney transplant recipients; MedDRA version: 9.1Level: LLTClassification code 10047626Term: Vitamin D deficiency; MedDRA version: 9.1Level: LLTClassification code 10023438Term: Kidney transplant

• Registration Number: EUCTR2008-002807-21-AT
• Lead Sponsor: MUW, Universitätsklinik für Innere Medizin III, Abteilung für Nephrologie und Dialyse

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09-04
• Last Update Posted: 26 February 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Age >18
Deceased donor kidney transplant recipients
Only kidney transplant recipients
Vitamin D deficiency defined as 25OHD <50nmol/l

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Re-transplantation for the second time if the patient is highly immunized and therefore included in the apheresis program
Re-transplantation for the third time or more often
Significant impaired intestinal resorption: malabsorption due to celiac sprue, systemic scleroderma; maldigestion due to chronic pancreatitis, pancreatic insufficiency, pancreas resection, mukoviscidosis, Zollinger-Ellison-syndrom
History of inflammatory bowel disease: Crohn’s disease, Ulcerative Colitis
Previouse gastrectomy, small bowel or large bowel resection, intestinal bypass surgery
Severe liver disease: cirrhosis
HIV positive (HAART enhances Vitamin D catabolism)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified