Efficacy of Usual Vitamin D Supplementation and Its Impact on Children and Adolescents Calciuria.

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02238418
• Date of registration: 10/09/2014
• Prospective Registration: No
• Primary sponsor: Hospices Civils de Lyon
• Public title: Efficacy of Usual Vitamin D Supplementation and Its Impact on Children and Adolescents Calciuria. VITATOL
• Scientific title: Vitamin D Supplementation in Children and Adolescents Seen in the Paediatric Nephrology Service: Study of the Efficacy of Service Usual Care (Cholecalciferol) and Its Impact on Calciuria.
• Date of first enrolment: September 2014
• Target sample size: 43
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02238418
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

France

Contacts

• Name: Justine Bacchetta, MD
• Affiliation: HCL

Key inclusion & exclusion criteria

Inclusion Criteria:

- Age : between [18 mo et 18 yo[

- Patients seen in the paediatric nephrology service and having :

- Chronic kidney disease

- Renal transplant

- Stable nephrotic syndrome (i.e., normal protidemia at inclusion)

- Initial 25 OH vitamin D concentration < 75nmol/l

- Patient agree to participate (if old enough to give his agreement) and written
informed consent signed by parents

- Patients affiliated within the French universal healthcare system

Exclusion Criteria:

- Contraindication to 100 000 IU Uvedose® treatment (according to the Summary of Product
Characteristics: known hypersensitivity to vitamin D or hypercalcemia, hypercalciuria or
nephrolithiasis).



Age minimum: 18 Months
Age maximum: 18 Years
Gender: All

Health Condition(s) or Problem(s) studied

Chronic Kidney Disease

Nephrotic Syndrome

Renal Transplantation

Intervention(s)

Drug: Cholecalciferol vial (100 000 UI)

Primary Outcome(s)

Efficacy of usual vitamin D supplementation [Time Frame: Day 60]

Secondary Outcome(s)

Kinetics of calciuria after a 100 000 IU vial of cholecalciferol [Time Frame: Day 0, day 1, day 2, day 3, day 4, day 7 after treatment intake.]

Secondary ID(s)

2013-812

2013-002710-13

Source(s) of Monetary Support

Please refer to primary and secondary sponsors