Status:
COMPLETED
VITamine D Supplementation in RenAL Transplant Recipients - VITALE
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Laboratoire Crinex
URC-CIC Paris Descartes Necker Cochin
Conditions:
Renal Transplant Candidate for Right Kidney
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
It has been proposed that the intake of high dose of cholecalciferol may have beneficial non classical effects (beside bone health). This could include the reduction of type 2 diabetes mellitus, cardi...
Detailed Description
Rationale : Vitamin D cannot be considered any more as only necessary to prevent rickets or osteomalacia. Calcitriol produced in the kidney is known to have classical endocrine PHOSPHOCALCIC properti...
Eligibility Criteria
Inclusion
- Renal transplant recipients between 12 and 48 months after transplantation with a stable renal function during the past 3 months.
- Vitamine D insufficiency defined as a concentration of 25OHD lower than 30 ng/ml.
- Patient between 18 and 75 years old
- Patient capable of understanding the advantages and the risks of the study.
- Affiliated with social security health insurance
- Written informed consent
Exclusion
- Calcaemia \> 2,7 mmol/l
- Phosphataemia \> 1,5 mmol/l
- Serum creatinine \> 250 µmol/l
- Treatment by an active form of the vitamin D not being able to be interrupted
- Transplant of an organ other than the kidney
- Type I or type II diabetes mellitus
- Past medical history of granulomatosis or active granulomatosis
- Primary hyperoxaluria
- Malabsorption proved by the liposoluble vitamins
- Simultaneous participation in another therapeutic essay
- Patients presenting a drug addiction or a psychiatric disorder
- Pregnant or breast-feeding women
- Vitamin D hyper sensibility
Key Trial Info
Start Date :
January 6 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 2 2016
Estimated Enrollment :
538 Patients enrolled
Trial Details
Trial ID
NCT01431430
Start Date
January 6 2012
End Date
February 2 2016
Last Update
September 8 2025
Active Locations (1)
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1
Georges Pompidou European Hospital
Paris, France, 75015