Assessing the Impact of a Mode of Vitamin D Supplementation (Sequential Dose vs Daily Dose) on the Incidence of Hypercalciuria in Subjets Aged From 2 to 18 Years

Not Applicable

Recruiting

• Conditions: Transient Hypercalciuria
• Interventions: Drug: Cholecalciferol sequential dose; Drug: Cholecalciferol daily dose

• Registration Number: NCT02975492
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

Recommendations for vitamin D supplementation for subjets between 2 and 18 years offer strong sequential doses of vitamin D: 2 times 100 000 units in spaced winter period of 3 months. Data from the literature show a further increase in the incidence of oxalo-calcium stones in children and adolescents associated with hypercalciuria with training Randall plates, essential step lithogenesis calcium oxalate. Knowing the links between vitamin D and urinary calcium excretion, these data lead to the question of increased sensitivity in some children with vitamin D, sensitivity could explain these situations with hypercalciuria increase the gallstone risk. This increased sensitivity to vitamin D may unmask particularly if inputs of high doses of vitamin responsible then a transient hypercalciuria with development of microcrystals.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-07
• Study First Submitted QC: 2016-11-28
• Study First Posted: 2016-11-29
• Study Start: 2017-12-14
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-07
• Last Update Posted: 2023-04-10
• Primary Completion: 2024-05
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

• Children aged 2 to 17 years included
• Obtaining informed consent of the parents signed
• Participants aged 18 years included

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cholecalciferol sequential dose	Cholecalciferol sequential dose	cholecalciferol : 100 000 Unit International (UI), sequential dose (2 mL)
Cholecalciferol daily dose	Cholecalciferol daily dose	cholecalciferol : 1000 UI, daily dose during 28 days (0.1 ml by day)

Primary Outcome Measures

Name	Time	Method
Changes from calcium level in urines at day 7, day 14 and day 28	day 7, day 14 and day 28

Trial Locations

Locations (1)

Pediatric department; 🇫🇷 Nîmes, France