<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02975492</url>
  </required_header>
  <id_info>
    <org_study_id>RECHMPL15_0500</org_study_id>
    <secondary_id>UF 9676</secondary_id>
    <nct_id>NCT02975492</nct_id>
  </id_info>
  <brief_title>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</brief_title>
  <acronym>DonneDVit</acronym>
  <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 Sujets Des départements du Gard et de l'Hérault agés de 2 à 18 Ans. Etude contrôlée randomisée en 2 Groupes parallèles</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Montpellier</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Recommendations for vitamin D supplementation for subjets between 2 and 18 years offer strong&#xD;
      sequential doses of vitamin D: 2 times 100 000 units in spaced winter period of 3 months.&#xD;
      Data from the literature show a further increase in the incidence of oxalo-calcium stones in&#xD;
      children and adolescents associated with hypercalciuria with training Randall plates,&#xD;
      essential step lithogenesis calcium oxalate. Knowing the links between vitamin D and urinary&#xD;
      calcium excretion, these data lead to the question of increased sensitivity in some children&#xD;
      with vitamin D, sensitivity could explain these situations with hypercalciuria increase the&#xD;
      gallstone risk. This increased sensitivity to vitamin D may unmask particularly if inputs of&#xD;
      high doses of vitamin responsible then a transient hypercalciuria with development of&#xD;
      microcrystals.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 14, 2017</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">May 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes from calcium level in urines at day 7, day 14 and day 28</measure>
    <time_frame>day 7, day 14 and day 28</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">280</enrollment>
  <condition>Transient Hypercalciuria</condition>
  <arm_group>
    <arm_group_label>Cholecalciferol sequential dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>cholecalciferol : 100 000 Unit International (UI), sequential dose (2 mL)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cholecalciferol daily dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>cholecalciferol : 1000 UI, daily dose during 28 days (0.1 ml by day)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cholecalciferol sequential dose</intervention_name>
    <description>sequential dose administration of the treatment</description>
    <arm_group_label>Cholecalciferol sequential dose</arm_group_label>
    <other_name>Vitamin D</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cholecalciferol daily dose</intervention_name>
    <description>daily dose administration of the treatment</description>
    <arm_group_label>Cholecalciferol daily dose</arm_group_label>
    <other_name>Vitamin D</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children aged 2 to 17 years included&#xD;
&#xD;
          -  Obtaining informed consent of the parents signed&#xD;
&#xD;
          -  Participants aged 18 years included&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Denis MORIN, MD</last_name>
    <phone>0467336607</phone>
    <email>d-morin@chu-montpellier.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Pediatric department</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Denis MORIN, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Pediatric department</name>
      <address>
        <city>Nîmes</city>
        <zip>30029</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tu-Anh TRAN, MD</last_name>
      <phone>04 66 68 32 84</phone>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>November 7, 2016</study_first_submitted>
  <study_first_submitted_qc>November 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>April 7, 2023</last_update_submitted>
  <last_update_submitted_qc>April 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypercalciuria</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin D</mesh_term>
    <mesh_term>Ergocalciferols</mesh_term>
    <mesh_term>Cholecalciferol</mesh_term>
    <mesh_term>Vitamins</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02975492
org study id: RECHMPL15_0500
secondary id: UF 9676
nct id: NCT02975492
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Changes from calcium level in urines at day 7, day 14 and day 28
time frame: day 7, day 14 and day 28
arm group label: Cholecalciferol sequential dose
arm group type: Experimental
description: cholecalciferol : 100 000 Unit International (UI), sequential dose (2 mL)
arm group label: Cholecalciferol daily dose
arm group type: Experimental
description: cholecalciferol : 1000 UI, daily dose during 28 days (0.1 ml by day)
intervention type: Drug
intervention name: Cholecalciferol sequential dose
description: sequential dose administration of the treatment
arm group label: Cholecalciferol sequential dose
other name: Vitamin D
intervention type: Drug
intervention name: Cholecalciferol daily dose
description: daily dose administration of the treatment
arm group label: Cholecalciferol daily dose
other name: Vitamin D
criteria: 
gender: All
minimum age: 2 Years
maximum age: 18 Years
healthy volunteers: No
last name: Denis MORIN, MD
phone: 0467336607
email: d-morin@chu-montpellier.fr
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Hypercalciuria
mesh term: Vitamin D
mesh term: Ergocalciferols
mesh term: Cholecalciferol
mesh term: Vitamins
sharing ipd: No