<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/NCT02186275</url>
  </required_header>
  <id_info>
    <org_study_id>JP2014</org_study_id>
    <nct_id>NCT02186275</nct_id>
  </id_info>
  <brief_title>The Vitamin D in Pediatric Crohn's Disease</brief_title>
  <acronym>ViDiPeC</acronym>
  <official_title>Randomized Controlled Trial of High Dose Vitamin D in Children With Newly Diagnosed Crohn's Disease for the Prevention of Relapses</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Justine's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Canadian Institutes of Health Research (CIHR)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>St. Justine's Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if vitamin D as an adjuvant therapy can improve the&#xD;
      outcome (i.e. fewer relapses) and the quality of life, including levels of physical activity,&#xD;
      in children with newly diagnosed Crohn's disease (CD).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Crohn's disease is a chronic inflammatory condition affecting all segments of the digestive&#xD;
      tract from the mouth to the anus. This condition is associated with an increased risk of&#xD;
      relapses throughout the course of the disease. Nearly 25% of patients with Crohn's disease&#xD;
      are in the pediatric age range. Many epidemiological data are in favor of an increase&#xD;
      incidence of pediatric Crohn's disease. Environmental factors could explain this increased&#xD;
      incidence. Among them sunlight exposure and vitamin D deficiency have been suggested by many&#xD;
      authors.&#xD;
&#xD;
      Recent studies have described how varying doses of oral vitamin D supplementation can alter&#xD;
      serum levels of 25 hydroxyvitamin D (25(OH)D), but no study has specifically addressed the&#xD;
      question as to whether vitamin D supplementation can alter the rate of relapse/complications&#xD;
      and/or quality of life in children diagnosed with CD.&#xD;
&#xD;
      Current treatments of CD at diagnosis are effective around the time of diagnosis, but in the&#xD;
      short and long term, some of these therapies are inefficient or lead to allergic or&#xD;
      intolerance reactions. Altogether the rate of relapses in the year after diagnosis is&#xD;
      significant. Thus, different therapeutic approaches must be investigated with the aim of&#xD;
      lowering the burden of the disease.&#xD;
&#xD;
      From November 2012 to July 2013, we conducted an open label pilot cohort study aiming to&#xD;
      investigate the bioavailability and tolerance of high doses of vitamin D3 (3,000 IU or 4,000&#xD;
      IU per day) administered orally as an adjunct therapy in 20 children with newly diagnosed&#xD;
      pediatric CD (http://clinicaltrials.gov/ct2/show/NCT01692808). Data from laboratory studies,&#xD;
      observational research and pilot trials taken together suggest that vitamin D can be of great&#xD;
      importance in the genesis and progression of CD. Vitamin D deficiency could be a true risk&#xD;
      factor for disease occurrence and/or relapses. The results of our pilot study demonstrate&#xD;
      that in children with active CD at diagnosis, a daily dose of 4,000 IU of vitamin D is well&#xD;
      tolerated and quickly increases the blood levels of 25OHD3 to 100 nmol/L or above in 100% of&#xD;
      children with CD at diagnosis. Moreover a maintenance dosage of 2,000 IU a day is required&#xD;
      (and sufficient) for maintaining this target over several months. Currently there is no&#xD;
      adequately powered study in the pediatric CD population exploring the relationship between&#xD;
      vitamin D therapy at diagnosis and CD outcomes.&#xD;
&#xD;
      We propose a randomized controlled trial (RCT) to study the efficacy of high-dose oral&#xD;
      vitamin D, as adjunct therapy, in children with newly diagnosed CD, to reduce the relapse&#xD;
      rate and to improve patients' quality of life.&#xD;
&#xD;
      Primary Efficacy End Point: The proportion of patient with at least one relapse 52 weeks&#xD;
      after randomization.&#xD;
&#xD;
      Secondary efficacy endpoint: Quality of life scores, Cumulative steroid dose, Time to first&#xD;
      relapse, Duration of corticotherapy, Number of relapses, Number of hospitalizations Safety&#xD;
      Endpoint : incidence of hypercalcemia (defined as a corrected serum calcium level &gt;2.65&#xD;
      mmol/L), incidence of hypercalciuria (defined as urinary calcium to creatinine molar ratio&#xD;
      ≥1.50), incidence of supra-optimal levels of 25OHD3 as defined by a serum level ≥ 250 nmol/L,&#xD;
      rate of study discontinuation due to hypercalcemia or hypercalciuria.&#xD;
&#xD;
      Efficacy Variable: Occurrence of relapse, Time to relapse, Change in QoL score from baseline&#xD;
      to 26 weeks, 52 weeks. Change in physical activity score from baseline to 26 weeks, 52 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 2016</start_date>
  <completion_date type="Actual">December 20, 2019</completion_date>
  <primary_completion_date type="Actual">December 20, 2019</primary_completion_date>
  <phase>Phase 3</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>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Occurrence of at least one relapse within 52 weeks after randomization in the trial.</measure>
    <time_frame>within 52 weeks after inclusion in the study</time_frame>
    <description>A relapse is defined as the occurrence of clinical symptoms (&gt; 2 bowel movements per day, abdominal pain, fever, weight loss, perianal disease or extra-intestinal symptoms) and a pediatric Crohn's disease Activity Index (PCDAI) &gt; 30.&#xD;
The PCDAI is a validated and reproducible tool that was developed by consensus at a meeting of pediatric (Inflammatory bowel disease) IBD experts and subsequently validated in 12 North American institutions. It includes 11 domains, with clinical symptoms, physical examination, laboratory parameters, and growth.&#xD;
The PCDAI score can range from 0-100, with higher scores signifying more active disease. A score &lt; 10 is consistent with inactive disease; 11-30 indicates mild disease; &gt; 30 suggests moderate to severe disease. The PCDAI has been used in many pediatric trials.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the lapse of time from randomization to first relapse</measure>
    <time_frame>from randomization to first relapse</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the number of relapses per patient per year</measure>
    <time_frame>within 52 weeks after randomization in the trial</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the duration of corticotherapy</measure>
    <time_frame>between randomization and 52 weeks later</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number of CD related hospitalizations</measure>
    <time_frame>between randomization and 52 weeks later</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The quality of life</measure>
    <time_frame>at 26 weeks and 52 weeks</time_frame>
    <description>as measured by the IMPACT III questionnaire. IMPACT III is a validated questionnaire that assesses disease-related quality-of-life in multiple domains of care in pediatric IBD (bowel symptoms; systemic symptoms; emotional functioning; functional/social impairment; body image; test-treatments). Overall scores for IMPACT III range from 35 to 175 with higher scores associated with better quality of life</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in the level of physical activities</measure>
    <time_frame>between randomization and 52 weeks later</time_frame>
    <description>As measured by the Canadian Health Measures Survey (CHMS) - Children's Physical ActivityQuestionnaire</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in bone mineral density</measure>
    <time_frame>between randomization and 52 weeks later</time_frame>
    <description>As assessed by dual energy X-ray absorptiometry (DXA)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Crohn's Disease</condition>
  <arm_group>
    <arm_group_label>Vitamin D3 3000 or 4000 UI/day then 2,000 UI/day</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>3000 UI or 4,000 UI/day as induction therapy (according to weight) for 4 weeks then 2,000 UIday as maintenance therapy for 48 weeks.&#xD;
The administration of vitamin D will be considered as an adjunct to conventional therapy (corticosteroids, exclusive enteral nutrition or immunosuppressive agents (ISA)).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vitamin D3 800 UI/day then 800 UI/day</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>800 UI/day as induction therapy for 4 weeks, then 800 UI/day as maintenance therapy for 48 weeks. The administration of vitamin D will be considered as an adjunct to conventional therapy (corticosteroids, exclusive enteral nutrition or immunosuppressive agents (ISA)).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vitamin D3: 3000 or 4000 UI/day then 2,000 UI/day</intervention_name>
    <description>Weight at inclusion &lt; 40 kg : 3 capsules of 1000 UI per day at induction and 2 capsules of 1000 UI per day at maintenance.&#xD;
Weight at inclusion ≥ 40 kg : 4 capsules of 1000 UI per day at induction and 2 capsules of 1000 UI per day at maintenance.</description>
    <arm_group_label>Vitamin D3 3000 or 4000 UI/day then 2,000 UI/day</arm_group_label>
    <other_name>Cholecalciferol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vitamin D3 800 UI/day then 800 UI/day</intervention_name>
    <description>Weight &lt; 40 kg: 2 capsules of 400 UI per day and 1 capsules of placebo at induction and 2 capsules of 400 UI per day at maintenance&#xD;
Weight ≥ 40 kg: 2 capsules of 400 UI per day and 2 capsules of placebo at induction and 2 capsules of 400 UI per day at maintenance</description>
    <arm_group_label>Vitamin D3 800 UI/day then 800 UI/day</arm_group_label>
    <other_name>Cholecalciferol</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Eligibility Criteria:&#xD;
&#xD;
        - Diagnosis of CD by the usual clinical, endoscopic and histological criteria and&#xD;
        classified according to the Paris classification&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Age at randomization between 9 and 18 years inclusively&#xD;
&#xD;
          -  Interval between diagnosis and randomization between 2 weeks and 6 months after the&#xD;
             diagnosis&#xD;
&#xD;
          -  Pediatric Crohn's Disease Activity Index (PCDAI) ≤ 30 at inclusion&#xD;
&#xD;
          -  Concurrent treatment with corticosteroids and/or enteral nutrition and/or thiopurines&#xD;
             (azathioprine, 6-mercaptopurine) and/or methotrexate and/or 5-aminosalicylic acid&#xD;
             (5-ASA) and/or TNF-α inhibitors (Infliximab, Adalimumab).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient diagnosed with severe complex perianal fistulizing CD (defined as the presence&#xD;
             at diagnosis of a high intersphincteric, transsphincteric, extrasphincteric, or&#xD;
             suprasphincteric complex perianal fistula)&#xD;
&#xD;
          -  Known chronic liver cholestasis (defined by an elevation of conjugated bilirubin&#xD;
             and/or gamma glutamyl transferase &gt; 3 upper limit normal)&#xD;
&#xD;
          -  Known renal dysfunction requiring chronic dialysis or creatinine ≥ 100 micromol/L.&#xD;
&#xD;
          -  Known congenital bone disease&#xD;
&#xD;
          -  Known cystic fibrosis or other exocrine pancreatic insufficiency.&#xD;
&#xD;
          -  Currently treated with anticonvulsants metabolized through cytochrome P-450&#xD;
&#xD;
          -  Unable to take oral capsule form.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>9 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Prevost Jantchou, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Justine's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Edmonton Clinic Health Academy</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 1C9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of British Columbia</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6H 3V4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Health Science Center Pediatric</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <zip>R3A 1R9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Janeway Children's Health Centre</name>
      <address>
        <city>St. John's</city>
        <state>Newfoundland and Labrador</state>
        <zip>A1B 3V6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IWK Health Centre</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3K 6R8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McMaster University</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8S4L8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital for Sick Childrens</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 1X8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ste-Justine hospital</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3T1C5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montreal Children's Hospital (Montreal).</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H3H 1P3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire Laval</name>
      <address>
        <city>Québec</city>
        <zip>G1V 4G2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>July 4, 2014</study_first_submitted>
  <study_first_submitted_qc>July 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <last_update_submitted>September 21, 2020</last_update_submitted>
  <last_update_submitted_qc>September 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>St. Justine's Hospital</investigator_affiliation>
    <investigator_full_name>Jantchou Prevost</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Crohn</keyword>
  <keyword>vitamin D</keyword>
  <keyword>remission</keyword>
  <keyword>inflammation</keyword>
  <keyword>tolerance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Crohn Disease</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>
  <!-- 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/NCT02186275
org study id: JP2014
nct id: NCT02186275
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to determine if vitamin D as an adjuvant therapy can improve the
      outcome (i.e. fewer relapses) and the quality of life, including levels of physical activity,
      in children with newly diagnosed Crohn's disease (CD).
Crohn's disease is a chronic inflammatory condition affecting all segments of the digestive
      tract from the mouth to the anus. This condition is associated with an increased risk of
      relapses throughout the course of the disease. Nearly 25% of patients with Crohn's disease
      are in the pediatric age range. Many epidemiological data are in favor of an increase
      incidence of pediatric Crohn's disease. Environmental factors could explain this increased
      incidence. Among them sunlight exposure and vitamin D deficiency have been suggested by many
      authors.

      Recent studies have described how varying doses of oral vitamin D supplementation can alter
      serum levels of 25 hydroxyvitamin D (25(OH)D), but no study has specifically addressed the
      question as to whether vitamin D supplementation can alter the rate of relapse/complications
      and/or quality of life in children diagnosed with CD.

      Current treatments of CD at diagnosis are effective around the time of diagnosis, but in the
      short and long term, some of these therapies are inefficient or lead to allergic or
      intolerance reactions. Altogether the rate of relapses in the year after diagnosis is
      significant. Thus, different therapeutic approaches must be investigated with the aim of
      lowering the burden of the disease.

      From November 2012 to July 2013, we conducted an open label pilot cohort study aiming to
      investigate the bioavailability and tolerance of high doses of vitamin D3 (3,000 IU or 4,000
      IU per day) administered orally as an adjunct therapy in 20 children with newly diagnosed
      pediatric CD (http://clinicaltrials.gov/ct2/show/NCT01692808). Data from laboratory studies,
      observational research and pilot trials taken together suggest that vitamin D can be of great
      importance in the genesis and progression of CD. Vitamin D deficiency could be a true risk
      factor for disease occurrence and/or relapses. The results of our pilot study demonstrate
      that in children with active CD at diagnosis, a daily dose of 4,000 IU of vitamin D is well
      tolerated and quickly increases the blood levels of 25OHD3 to 100 nmol/L or above in 100% of
      children with CD at diagnosis. Moreover a maintenance dosage of 2,000 IU a day is required
      (and sufficient) for maintaining this target over several months. Currently there is no
      adequately powered study in the pediatric CD population exploring the relationship between
      vitamin D therapy at diagnosis and CD outcomes.

      We propose a randomized controlled trial (RCT) to study the efficacy of high-dose oral
      vitamin D, as adjunct therapy, in children with newly diagnosed CD, to reduce the relapse
      rate and to improve patients' quality of life.

      Primary Efficacy End Point: The proportion of patient with at least one relapse 52 weeks
      after randomization.

      Secondary efficacy endpoint: Quality of life scores, Cumulative steroid dose, Time to first
      relapse, Duration of corticotherapy, Number of relapses, Number of hospitalizations Safety
      Endpoint : incidence of hypercalcemia (defined as a corrected serum calcium level >2.65
      mmol/L), incidence of hypercalciuria (defined as urinary calcium to creatinine molar ratio
      ≥1.50), incidence of supra-optimal levels of 25OHD3 as defined by a serum level ≥ 250 nmol/L,
      rate of study discontinuation due to hypercalcemia or hypercalciuria.

      Efficacy Variable: Occurrence of relapse, Time to relapse, Change in QoL score from baseline
      to 26 weeks, 52 weeks. Change in physical activity score from baseline to 26 weeks, 52 weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Occurrence of at least one relapse within 52 weeks after randomization in the trial.
time frame: within 52 weeks after inclusion in the study
description: A relapse is defined as the occurrence of clinical symptoms (> 2 bowel movements per day, abdominal pain, fever, weight loss, perianal disease or extra-intestinal symptoms) and a pediatric Crohn's disease Activity Index (PCDAI) > 30.
The PCDAI is a validated and reproducible tool that was developed by consensus at a meeting of pediatric (Inflammatory bowel disease) IBD experts and subsequently validated in 12 North American institutions. It includes 11 domains, with clinical symptoms, physical examination, laboratory parameters, and growth.
The PCDAI score can range from 0-100, with higher scores signifying more active disease. A score < 10 is consistent with inactive disease; 11-30 indicates mild disease; > 30 suggests moderate to severe disease. The PCDAI has been used in many pediatric trials.
measure: the lapse of time from randomization to first relapse
time frame: from randomization to first relapse
measure: the number of relapses per patient per year
time frame: within 52 weeks after randomization in the trial
measure: the duration of corticotherapy
time frame: between randomization and 52 weeks later
measure: The number of CD related hospitalizations
time frame: between randomization and 52 weeks later
measure: The quality of life
time frame: at 26 weeks and 52 weeks
description: as measured by the IMPACT III questionnaire. IMPACT III is a validated questionnaire that assesses disease-related quality-of-life in multiple domains of care in pediatric IBD (bowel symptoms; systemic symptoms; emotional functioning; functional/social impairment; body image; test-treatments). Overall scores for IMPACT III range from 35 to 175 with higher scores associated with better quality of life
measure: Change in the level of physical activities
time frame: between randomization and 52 weeks later
description: As measured by the Canadian Health Measures Survey (CHMS) - Children's Physical ActivityQuestionnaire
measure: Changes in bone mineral density
time frame: between randomization and 52 weeks later
description: As assessed by dual energy X-ray absorptiometry (DXA)
arm group label: Vitamin D3 3000 or 4000 UI/day then 2,000 UI/day
arm group type: Experimental
description: 3000 UI or 4,000 UI/day as induction therapy (according to weight) for 4 weeks then 2,000 UIday as maintenance therapy for 48 weeks.
The administration of vitamin D will be considered as an adjunct to conventional therapy (corticosteroids, exclusive enteral nutrition or immunosuppressive agents (ISA)).
arm group label: Vitamin D3 800 UI/day then 800 UI/day
arm group type: Active Comparator
description: 800 UI/day as induction therapy for 4 weeks, then 800 UI/day as maintenance therapy for 48 weeks. The administration of vitamin D will be considered as an adjunct to conventional therapy (corticosteroids, exclusive enteral nutrition or immunosuppressive agents (ISA)).
intervention type: Drug
intervention name: Vitamin D3: 3000 or 4000 UI/day then 2,000 UI/day
description: Weight at inclusion < 40 kg : 3 capsules of 1000 UI per day at induction and 2 capsules of 1000 UI per day at maintenance.
Weight at inclusion ≥ 40 kg : 4 capsules of 1000 UI per day at induction and 2 capsules of 1000 UI per day at maintenance.
arm group label: Vitamin D3 3000 or 4000 UI/day then 2,000 UI/day
other name: Cholecalciferol
intervention type: Drug
intervention name: Vitamin D3 800 UI/day then 800 UI/day
description: Weight < 40 kg: 2 capsules of 400 UI per day and 1 capsules of placebo at induction and 2 capsules of 400 UI per day at maintenance
Weight ≥ 40 kg: 2 capsules of 400 UI per day and 2 capsules of placebo at induction and 2 capsules of 400 UI per day at maintenance
arm group label: Vitamin D3 800 UI/day then 800 UI/day
other name: Cholecalciferol
criteria: 
gender: All
minimum age: 9 Years
maximum age: 18 Years
healthy volunteers: No
last name: Prevost Jantchou, MD
role: Principal Investigator
affiliation: St. Justine's Hospital
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: St. Justine's Hospital
investigator full name: Jantchou Prevost
investigator title: MD
mesh term: Crohn Disease
mesh term: Vitamin D
mesh term: Ergocalciferols
mesh term: Cholecalciferol
mesh term: Vitamins