Modalities of vitamin D supplementation and the risk of hypercalcemia in children aged 2 to 6 years

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-001807-22-FR

Enrollment

280

Registered

2016-07-20

Start date

Unknown

Completion date

Unknown

Last updated

2024-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

children receiving supplementation

Interventions

Trade Name: Uvesterol Pharmaceutical Form: Oral liquid Trade Name: Uvedose Pharmaceutical Form: Oral liquid

Eligibility

Sex/Gender

All

Inclusion criteria

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

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,

Design outcomes

Primary

Measure	Time frame
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. 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	—

Measure

Time frame

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. 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

Measure	Time frame
Secondary end point(s): calcium oxalate microcrystals in urine;Timepoint(s) of evaluation of this end point: D7, D14 and D28	—

Countries

France

Contacts

Public ContactCyril AMOUROUX

UH Montpellier

c-amouroux@chu-montpellier.fr33467336428

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026