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VITATOL: Vitamin D Supplementation in Pediatric Nephrology
NCT02238418Phase 4
Key facts
- Status
- Completed
- Start
- Sep 2014
- Primary completion
- Oct 2017
- Countries
- 1
- Sponsor
- Hospices Civils de Lyon
- Modality
- Small Molecules
- Drugs
- Calcirol
- Conditions
- Vitamin D deficiency (VDD)
01
Overview
Phase 4, open-label, single-arm trial of Calcirol in Vitamin D deficiency (VDD), sponsored by Hospices Civils de Lyon. Primary endpoint: Efficacy of usual vitamin D supplementation (Serum 25-OH Vitamin D concentration) at Day 60. Started Sep 2014; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Usual vitamin D supplementation
Patients receive Cholecalciferol according to the service's usual care protocol based on weight and initial Vitamin D levels.
03
Who it enrols
Children aged 18 months to 18 years with chronic kidney disease, renal transplant, or stable nephrotic syndrome, and vitamin D deficiency (< 75 nmol/L). Excludes patients with hypercalcemia, hypercalciuria, or nephrolithiasis.
04
Endpoints
Primary
Efficacy of usual vitamin D supplementation (Serum 25-OH Vitamin D concentration)
Secondary
Kinetics of calciuria after a 100 000 IU vial of cholecalciferol
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