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DonneDVit: Assessing the Impact of a Mode of Vitamin D Supplementation (Sequential Dose vs Daily Dose) on the Incidence of Hypercalciuria in Children Aged From 2 to 6 Years

Sponsor
University Hospital, Montpellier (Other)
Overall Status
Recruiting
CT.gov ID
NCT02975492
Collaborator
(none)
280
Enrollment
2
Locations
2
Arms
70.6
Anticipated Duration (Months)
140
Patients Per Site
2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Recommendations for vitamin D supplementation for children between 2 and 6 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Cholecalciferol sequential dose
  • Drug: Cholecalciferol daily dose
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
280 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Evaluation de l'Impact d'un Mode de supplémentation en Vitamine D (Dose séquentielle vs Dose Quotidienne) Sur l'Incidence de l'Hypercalciurie Chez Des Enfants Des départements du Gard et de l'Hérault agés de 2 à 6 Ans. Etude contrôlée randomisée en 2 Groupes parallèles
Actual Study Start Date :
Dec 14, 2017
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
Nov 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cholecalciferol sequential dose

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

Drug: Cholecalciferol sequential dose
sequential dose administration of the treatment
Other Names:
  • Vitamin D

    		•
    Experimental: Cholecalciferol daily dose

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

    Drug: Cholecalciferol daily dose
    daily dose administration of the treatment
    Other Names:
  • Vitamin D

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Changes from calcium level in urines at day 7, day 14 and day 28 [day 7, day 14 and day 28]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years to 6 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Children aged 2 to 6 years included included

    • Obtaining informed consent of the parents signed

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pediatric department Montpellier France 34295
    2 Pediatric department Nîmes France 30029

    Sponsors and Collaborators

    • University Hospital, Montpellier

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Montpellier
    ClinicalTrials.gov Identifier:
    NCT02975492
    Other Study ID Numbers:
    • RECHMPL15_0500
    • UF 9676
    First Posted:
    Nov 29, 2016
    Last Update Posted:
    Dec 21, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Hypercalciuria
    Vitamin D
    Ergocalciferols
    Cholecalciferol
    Vitamins

    Study Results

    No Results Posted as of Dec 21, 2021