Modalities of vitamin D supplementation and the risk of hypercalcemia in children aged 2 to 6 years
Phase 1
- Conditions
- children receiving supplementationTherapeutic area: Not possible to specify
- Registration Number
- EUCTR2016-001807-22-FR
- Lead Sponsor
- uh Montpellier
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Children aged 2 to 6 years included
Are the trial subjects under 18? yes
Number of subjects for this age range: 280
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Children who received vitamin D bulb (80 000 or 100 000 units) in the month before the study entry,
• Children with a known disease that can sound phosphate metabolism
• children receiving treatment hypercalciuriant
• Children receiving calcium supplementation justified by medical need,
• Children with prolonged immobilization,
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The objective of this study is to demonstrate the impact of vitamin D supplementation mode (daily supplementation vs supplementation loading doses) in hypercalciuria and development of microcrystals without being associated with overdose vitamin D.;Secondary Objective: Study the impact of vitamin D supplementation mode (strong sequential dose or daily intake) on the occurrence of calcium oxalate microcrystals in children around the Mediterranean aged 2 to 6 years.<br>Assess tolerability.;Primary end point(s): Hypercalciuria beyond the pathogenic threshold for age. It will be evaluated by the determination of calcium / creatinine in mmol / mmol on the first morning urine occurring during at least one of the three measurements in D7, D14 and D28.;Timepoint(s) of evaluation of this end point: D7, D14 and D28
- Secondary Outcome Measures
Name Time Method Secondary end point(s): calcium oxalate microcrystals in urine;Timepoint(s) of evaluation of this end point: D7, D14 and D28