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

NCT ID: NCT02975492

Last Updated: 2023-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-14

Study Completion Date

2024-12-31

Brief Summary

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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

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Conditions

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Transient Hypercalciuria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Cholecalciferol sequential dose

cholecalciferol : 100 000 Unit International (UI), sequential dose (2 mL)

Group Type EXPERIMENTAL

Cholecalciferol sequential dose

Intervention Type DRUG

sequential dose administration of the treatment

Cholecalciferol daily dose

cholecalciferol : 1000 UI, daily dose during 28 days (0.1 ml by day)

Group Type EXPERIMENTAL

Cholecalciferol daily dose

Intervention Type DRUG

daily dose administration of the treatment

Interventions

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Cholecalciferol sequential dose

sequential dose administration of the treatment

Intervention Type DRUG

Cholecalciferol daily dose

daily dose administration of the treatment

Intervention Type DRUG

Other Intervention Names

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Vitamin D Vitamin D

Eligibility Criteria

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Inclusion Criteria

* Children aged 2 to 17 years included
* Obtaining informed consent of the parents signed
* Participants aged 18 years included
Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Pediatric department

Montpellier, , France

Site Status RECRUITING

Pediatric department

Nîmes, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Denis MORIN, MD

Role: CONTACT

0467336607

Facility Contacts

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Denis MORIN, MD

Role: primary

Tu-Anh TRAN, MD

Role: primary

04 66 68 32 84

Other Identifiers

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UF 9676

Identifier Type: OTHER

Identifier Source: secondary_id

RECHMPL15_0500

Identifier Type: -

Identifier Source: org_study_id

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