<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/NCT02256605</url>
  </required_header>
  <id_info>
    <org_study_id>524835</org_study_id>
    <nct_id>NCT02256605</nct_id>
  </id_info>
  <brief_title>Vitamin D3 Supplementation in Pediatric IBD: Weely vs Daily Dosing Regimens</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nemours Children's Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>NASPGHAN Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Nemours Children's Clinic</source>
  <brief_summary>
    <textblock>
      The purpose of this prospecitve randomized controlled trial is to compare effectiveness and&#xD;
      patient/family adherence of weekly or daily Vitamin D-3 dosing regimens in children with&#xD;
      Inflammatory Bowel Disease (IBD) who are 25-hydroxyvitamin D [25(OH)D] insufficient or&#xD;
      deficient. The primary aim of this pilot study is to evaluate the effectiveness of once&#xD;
      weekly verses daily D-3 dosing regimens based on the most current IBD supplementation&#xD;
      guidelines in improving 25(OH)D levels. A seconary aim is to determine if there is difference&#xD;
      in adherence between dosing regimns.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2013</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">May 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>25 \(OH)D level will be recorded at baseline and at 8 weeks as an absolute value (ratio data) and the percentage and direction (increase or decrease) of change between baseline and end of treatment level.</measure>
    <time_frame>8 weeks</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Inflammatory Bowel Disease (IBD)</condition>
  <arm_group>
    <arm_group_label>Insufficient Group</arm_group_label>
    <description>D-3 Chewable Wafer - 14,000 IU/wafer weekly Vitamin D-3 Caps - 2,000 IU/Cap daily Vitamin D-3 Liquid - 5,000 IU/ml (0.4) ml daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Deficient Group</arm_group_label>
    <description>D-3 Chewable Wafer - 50,000 IU/wafer weekly Vitamin D-3 Liquid - 5,000 IU/ml daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Vitamin D-3</intervention_name>
    <description>Children with IBD, aged 5 to 17, who are vitamin D insufficient or deficient will be recruited at the time of a routine clinic visit or lab draw that included a 25(OH)D level as part of clinical practice/standard care. Once consent and assent are obtained, the children who are 25-hydroxyvitamin D [259OH)D] insufficient or deficient will be randomly assigned to a daily or weekly dosing regimen using block randomization to ensure equal group size.</description>
    <arm_group_label>Deficient Group</arm_group_label>
    <arm_group_label>Insufficient Group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Children with IBD, aged 5 to 17, who are vitamin D insufficient or deficient will be&#xD;
        recruited at the time of a rountine clinic visit or lab draw that includes a 25(OH)D level&#xD;
        as part of a clinical practice/standard of care.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects aged 5 to 17 years with a diagnosis of Inflammatory Bowel Disease, who have a&#xD;
             25(OH)D level below 30 ng/ml within 2 weeks of enrollment&#xD;
&#xD;
          -  Subject/family must be able and willing to take oral medications, complete a 3 day&#xD;
             dietary record, and return for 8 week concluding visit or clinicl visit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects will not be eligible if they are intolerant of vitamin supplementation or any&#xD;
             ingredients in the chosen supplment, are unable or unwilling to take oral supplements,&#xD;
             or are on specific medical therapy for diminished bone mineral density&#xD;
&#xD;
          -  Children with parathryoid disease, granulomatous disorders or William's syndrome will&#xD;
             also be excluded from the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Nemours Children's Clinic</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>October 1, 2014</study_first_submitted>
  <study_first_submitted_qc>October 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2014</study_first_posted>
  <last_update_submitted>May 28, 2015</last_update_submitted>
  <last_update_submitted_qc>May 28, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 29, 2015</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>Inflammatory Bowel Diseases</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>Cholecalciferol</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02256605
org study id: 524835
nct id: NCT02256605
lead sponsor: 
collaborator: 
The purpose of this prospecitve randomized controlled trial is to compare effectiveness and
      patient/family adherence of weekly or daily Vitamin D-3 dosing regimens in children with
      Inflammatory Bowel Disease (IBD) who are 25-hydroxyvitamin D [25(OH)D] insufficient or
      deficient. The primary aim of this pilot study is to evaluate the effectiveness of once
      weekly verses daily D-3 dosing regimens based on the most current IBD supplementation
      guidelines in improving 25(OH)D levels. A seconary aim is to determine if there is difference
      in adherence between dosing regimns.
observational model: Cohort
time perspective: Prospective
measure: 25 \(OH)D level will be recorded at baseline and at 8 weeks as an absolute value (ratio data) and the percentage and direction (increase or decrease) of change between baseline and end of treatment level.
time frame: 8 weeks
arm group label: Insufficient Group
description: D-3 Chewable Wafer - 14,000 IU/wafer weekly Vitamin D-3 Caps - 2,000 IU/Cap daily Vitamin D-3 Liquid - 5,000 IU/ml (0.4) ml daily
arm group label: Deficient Group
description: D-3 Chewable Wafer - 50,000 IU/wafer weekly Vitamin D-3 Liquid - 5,000 IU/ml daily
intervention type: Dietary Supplement
intervention name: Vitamin D-3
description: Children with IBD, aged 5 to 17, who are vitamin D insufficient or deficient will be recruited at the time of a routine clinic visit or lab draw that included a 25(OH)D level as part of clinical practice/standard care. Once consent and assent are obtained, the children who are 25-hydroxyvitamin D [259OH)D] insufficient or deficient will be randomly assigned to a daily or weekly dosing regimen using block randomization to ensure equal group size.
arm group label: Deficient Group
arm group label: Insufficient Group
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 5 Years
maximum age: 17 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Inflammatory Bowel Diseases
mesh term: Vitamin D
mesh term: Cholecalciferol