<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/NCT02197702</url>
  </required_header>
  <id_info>
    <org_study_id>DIVA</org_study_id>
    <nct_id>NCT02197702</nct_id>
  </id_info>
  <brief_title>Vitamin D in Preschoolers With Viral-induced Asthma</brief_title>
  <acronym>DIVA</acronym>
  <official_title>Vitamin D In the Prevention of Viral-induced Asthma of Preschoolers: a Randomised Controlled Trial (RCT)- (DIVA)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Justine's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Hospital for Sick Children</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centre de recherche du Centre hospitalier universitaire de Sherbrooke</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Montreal Children's Hospital of the MUHC</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>British Columbia Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>London Health Sciences Centre</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>
      In this 7-month randomized controlled trial, children aged 1-6 years with asthma attacks&#xD;
      triggered mostly by colds, will receive a high dose of vitamin D or a placebo every 3.5&#xD;
      months during their usual clinic visit. This study will test whether children receiving a&#xD;
      high dose of vitamin D have less frequent and less severe asthma exacerbations compared with&#xD;
      those receiving placebo.The study will also document the safety profile of this strategy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      IMPORTANT NOTE: Due to receiving a 2-year partial funding enabling only a single-centre pilot&#xD;
      trial, rather than an adequately-powered multicentre study, the primary outcome was modified&#xD;
      post hoc for the overall change from baseline in total serum 25OHD during the study as well&#xD;
      as at 3.5 and 7 months, similar to our previous pilot study.(NCT01999907) Post hoc secondary&#xD;
      outcomes included the group difference in the proportion of children with total 25OHD ≥75&#xD;
      nmol/L at 3.5 and 7 months and in the rate of oral corticosteroid courses per child. Other a&#xD;
      priory specified outcomes included the proportion of children with hypercalciuria (Ca:Cr)&#xD;
      &gt;1.25 (1-2 years), &gt;1 (2-5 years) nmol/nmol at any point in time; proportion of children with&#xD;
      ≥1 exacerbation requiring rescue oral steroids (former primary outcome); number of emergency&#xD;
      department (ED) visits; intensity and duration of asthma symptoms and cumulative use of&#xD;
      rescue ß2-agonist use, documented on Asthma Flare-up Diary for Young Children (ADYC); the&#xD;
      impact of parents' functional status during exacerbations ascertained on the Effect of a&#xD;
      child's asthma flare-up on parents; and duration of URTI.&#xD;
&#xD;
      Based on this analysis of this new post-hoc primary outcome, we have changed the intervention&#xD;
      and the primary outcome and obtained funding for a new large multicentre study NCT03365687.&#xD;
      it is thus important to share the results of this current trial with other investigators&#xD;
&#xD;
      PRIOR REPORTED DESCRIPTION Design: A multicenter triple-blind randomized parallel-group,&#xD;
      placebo-controlled trial of vitamin D3 supplementation. Children aged 1-5 years with (i)&#xD;
      physician-diagnosed asthma, predominantly triggered by upper respiratory tract infections&#xD;
      (URTIs), (ii) ≥4 reported URTIs in the past year, and (iii) ≥1 exacerbation requiring OCS (a&#xD;
      recognised marker of moderate and severe exacerbations) in the past 6 months or ≥2 in the&#xD;
      past 12 months, will be randomly allocated to one of two treatments in blocks of 4-6,&#xD;
      stratified on recruitment site: Intervention group (n=432)-100,000 IU oral vitamin D3;&#xD;
      control group (n=432)-identical placebo, for 2 oral doses, 3.5 months apart. Co-intervention&#xD;
      with asthma therapy (preventive or pre-emptive ICS) will be left to the discretion of the&#xD;
      physician and documented. Children will be followed every 3.5 months as per usual practice,&#xD;
      with a home visit 10 days after each bolus, during which urine and blood will be sampled for&#xD;
      urinary calcium:creatinine ratio, serum vitamin D, markers of calcium metabolism, and&#xD;
      mechanistic exploration. A validated diary will serve to document the intensity and severity&#xD;
      of exacerbations. In two sites, preschool lung function will be documented (if ≥ 3yrs).&#xD;
      Outcomes: Primary endpoint-number of exacerbations requiring rescue oral corticosteroids&#xD;
      (OCS) per child, documented by medical and pharmacy records. Secondary outcomes: duration and&#xD;
      severity of exacerbations (symptoms &amp; β2-agonist use, by diary; emergency visits, by medical&#xD;
      records), parental functional status (by validated instrument), asthma therapy&#xD;
      intensification and health care and direct costs (by health records &amp; parent reports).&#xD;
      Safety, mechanistic, exploratory outcomes: hypercalciuria, calcium metabolism, excess vitamin&#xD;
      D, change in serum gene expression at 10 days (first 25 patients); and change from baseline&#xD;
      at 7 months in preschool lung function (2 sites). Based on 3 published RCTs, a sample of 432&#xD;
      per arm (400+7.5% attrition) will provide 80% power (2-tailed alpha of 5%) to detect a 25%&#xD;
      reduction in number of exacerbations requiring OCS/child (0.55 vs. 0.4125).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">July 2016</completion_date>
  <primary_completion_date type="Actual">July 2016</primary_completion_date>
  <phase>Phase 2/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>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in serum 25OHD</measure>
    <time_frame>During the 7-month follow-up period</time_frame>
    <description>Group difference in the adjusted change from baseline 25OHD over time and specifically at 3.5 and 7 months</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of children with total 25OHD ≥75 nmol/L</measure>
    <time_frame>at 3.5 and 7 months</time_frame>
    <description>Group difference in the proportion of children with total 25OHD ≥75 nmol/L</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Hypercalciuria</measure>
    <time_frame>At any point during the 7-month follow-up period</time_frame>
    <description>Group difference in the proportion of children with ≥1 occurrence of hypercalciuria (urinary calcium: creatinine greater than 1.25mmol/mmol for children aged 1-2yrs (or greater than 1mmol/mmol for those aged 2-5yrs)</description>
  </other_outcome>
  <other_outcome>
    <measure>Elevated serum 25-hydroxyvitamin D (25OHD)</measure>
    <time_frame>At any point during the 7-month follow-up period</time_frame>
    <description>Proportion of children with ≥1 occurrence of elevated serum 25OHD (greater than 250nmol/L)</description>
  </other_outcome>
  <other_outcome>
    <measure>Perturbation of the calcium homeostasis</measure>
    <time_frame>At any point during the 7-month follow-up period</time_frame>
    <description>Proportion of children with ≥1 occurrence of a perturbation of the calcium homeostasis (serum Ca, Ph, Alkaline phosphatase), defined as outside normal laboratory values</description>
  </other_outcome>
  <other_outcome>
    <measure>RNA expression</measure>
    <time_frame>Over the 7 months after the intial dose of Vit D/Placebo</time_frame>
    <description>Group difference in the change from baseline in RNA expression measured between 0, 10 days, 3.5 months and 7 months post initial dose of Vit D/Placebo</description>
  </other_outcome>
  <other_outcome>
    <measure>Duration of URTIs</measure>
    <time_frame>During an URTI during the 7-month follow-up period</time_frame>
    <description>Group difference in the duration of URTI as documented by parents at the end of each episode</description>
  </other_outcome>
  <other_outcome>
    <measure>Viral upper respiratory tract infections (URTI)</measure>
    <time_frame>During the 7-month follow-up period</time_frame>
    <description>Group difference in the number of reported viral upper respiratory tract infections</description>
  </other_outcome>
  <other_outcome>
    <measure>Emergency department visit for an asthma flare-up</measure>
    <time_frame>During the 7-month follow-up period</time_frame>
    <description>Group difference in the number of emergency department visits for asthma</description>
  </other_outcome>
  <other_outcome>
    <measure>Rescue β2-agonist use during an asthma flare-up</measure>
    <time_frame>During the 7-month follow-up period</time_frame>
    <description>Group difference in the cumulative daily use of rescue β2-agonist use as documented by parents on the 'Asthma Flare-up Diary for Young CHildren' during a URTI or an asthma exacerbation</description>
  </other_outcome>
  <other_outcome>
    <measure>Severity of asthma symptoms during an asthma flare-up</measure>
    <time_frame>During an URTI or flare-up during the 7-month follow-up period</time_frame>
    <description>Group difference in the severity on the asthma symptoms documented as the sum of daily score on the 'Asthma FLare-up DIary for Young Children' questionnaire</description>
  </other_outcome>
  <other_outcome>
    <measure>Duration of asthma symptoms during a flare-up</measure>
    <time_frame>During an URTI or flare-up during the 7-month follow-up period</time_frame>
    <description>Group difference in the duration of asthma symptoms documented on the 'Asthma FLare-up DIary for Young Children' questionnaire</description>
  </other_outcome>
  <other_outcome>
    <measure>Exacerbations requiring rescue oral corticosteroids</measure>
    <time_frame>During the 7-month follow-up period</time_frame>
    <description>Mean group rate of exacerbations requiring rescue oral corticosteroids/child</description>
  </other_outcome>
  <other_outcome>
    <measure>Patients with exacerbations requiring rescue oral corticosteroids</measure>
    <time_frame>During the 7-month follow-up period</time_frame>
    <description>Proportion of children with ≥1 exacerbation requiring rescue oral corticosteroids</description>
  </other_outcome>
  <other_outcome>
    <measure>Impact of exacerbations on caregivers' functional status</measure>
    <time_frame>During an URTI or flare-up during the 7-month follow-up period</time_frame>
    <description>Group difference in the caregivers' functional status measured on the 'Effect of a child's asthma flare-up on parents' questionnaire</description>
  </other_outcome>
  <other_outcome>
    <measure>Impact of exacerbations on caregivers' workday lost</measure>
    <time_frame>During an URTI or flare-up during the 7-month follow-up period</time_frame>
    <description>Group difference in the caregivers' number of workday lost</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">47</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>2 ml identical placebo taken by mouth at baseline and 3.5 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vitamin D</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Vitamin D (100,000IU) given in a 2 ml oral dose at baseline and 3.5months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>vitamin D</intervention_name>
    <description>Two doses of cholecalciferol 100,000 unit (2 mL) given 3.5 months apart, once in the fall, once in the winter</description>
    <arm_group_label>Vitamin D</arm_group_label>
    <other_name>cholecalciferol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>Two doses of identical placebo (2 mL) given 3.5 months part, once in the fall, once in the winter</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age 1-5 years&#xD;
&#xD;
          -  physician-diagnosed asthma as per the Global Initiative for Asthma (GINA) guidelines&#xD;
&#xD;
          -  URTIs as the main asthma trigger (parental report)&#xD;
&#xD;
          -  ≥4 URTIs in the past 12 months (parental report)&#xD;
&#xD;
          -  ≥1 asthma exacerbation requiring rescue oral corticosteroids (OCS) in the past 6&#xD;
             months or ≥2 in the past 12 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  intake or intention to use more than 400 IU/day of vitamin D supplement&#xD;
&#xD;
          -  extreme prematurity (&lt;28 weeks gestation)&#xD;
&#xD;
          -  infants &lt;12 months of age&#xD;
&#xD;
          -  no vitamin D supplementation when breast-fed&#xD;
&#xD;
          -  recent (&lt;1 year) immigrants from a region at high risk of rickets&#xD;
&#xD;
          -  children with vitamin D restrictive diets e.g. vegans&#xD;
&#xD;
          -  other chronic respiratory disease (broncho-pulmonary dysplasia; cystic fibrosis)&#xD;
&#xD;
          -  condition(s) that alter calcium or vitamin D metabolism/absorption&#xD;
             (hypo/hyperparathyroidism, kidney/liver disease, inflammatory bowel disease)&#xD;
&#xD;
          -  medications that interfere with vitamin D metabolism (anti-epileptics, diuretics,&#xD;
             antacids, anti-fungal drug)&#xD;
&#xD;
          -  vitamin D supplementation &gt;1000 IU/ day in last 3 months&#xD;
&#xD;
          -  anticipated difficult follow-up (unable to attend clinic visits; plan to leave the&#xD;
             province).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>5 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Francine M Ducharme, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Justine's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU Sainte Justine</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3T1C5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>July 18, 2014</study_first_submitted>
  <study_first_submitted_qc>July 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 23, 2014</study_first_posted>
  <last_update_submitted>June 19, 2018</last_update_submitted>
  <last_update_submitted_qc>June 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 21, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>St. Justine's Hospital</investigator_affiliation>
    <investigator_full_name>Professor Francine Ducharme</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>RCT</keyword>
  <keyword>asthma</keyword>
  <keyword>pediatric</keyword>
  <keyword>virus</keyword>
  <keyword>corticosteroid</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</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>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>November 19, 2020</submitted>
    <returned>December 16, 2020</returned>
    <submitted>March 16, 2022</submitted>
    <returned>July 15, 2022</returned>
    <submitted>April 18, 2023</submitted>
  </pending_results>
  <!-- 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/NCT02197702
org study id: DIVA
nct id: NCT02197702
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
In this 7-month randomized controlled trial, children aged 1-6 years with asthma attacks
      triggered mostly by colds, will receive a high dose of vitamin D or a placebo every 3.5
      months during their usual clinic visit. This study will test whether children receiving a
      high dose of vitamin D have less frequent and less severe asthma exacerbations compared with
      those receiving placebo.The study will also document the safety profile of this strategy.
IMPORTANT NOTE: Due to receiving a 2-year partial funding enabling only a single-centre pilot
      trial, rather than an adequately-powered multicentre study, the primary outcome was modified
      post hoc for the overall change from baseline in total serum 25OHD during the study as well
      as at 3.5 and 7 months, similar to our previous pilot study.(NCT01999907) Post hoc secondary
      outcomes included the group difference in the proportion of children with total 25OHD ≥75
      nmol/L at 3.5 and 7 months and in the rate of oral corticosteroid courses per child. Other a
      priory specified outcomes included the proportion of children with hypercalciuria (Ca:Cr)
      >1.25 (1-2 years), >1 (2-5 years) nmol/nmol at any point in time; proportion of children with
      ≥1 exacerbation requiring rescue oral steroids (former primary outcome); number of emergency
      department (ED) visits; intensity and duration of asthma symptoms and cumulative use of
      rescue ß2-agonist use, documented on Asthma Flare-up Diary for Young Children (ADYC); the
      impact of parents' functional status during exacerbations ascertained on the Effect of a
      child's asthma flare-up on parents; and duration of URTI.

      Based on this analysis of this new post-hoc primary outcome, we have changed the intervention
      and the primary outcome and obtained funding for a new large multicentre study NCT03365687.
      it is thus important to share the results of this current trial with other investigators

      PRIOR REPORTED DESCRIPTION Design: A multicenter triple-blind randomized parallel-group,
      placebo-controlled trial of vitamin D3 supplementation. Children aged 1-5 years with (i)
      physician-diagnosed asthma, predominantly triggered by upper respiratory tract infections
      (URTIs), (ii) ≥4 reported URTIs in the past year, and (iii) ≥1 exacerbation requiring OCS (a
      recognised marker of moderate and severe exacerbations) in the past 6 months or ≥2 in the
      past 12 months, will be randomly allocated to one of two treatments in blocks of 4-6,
      stratified on recruitment site: Intervention group (n=432)-100,000 IU oral vitamin D3;
      control group (n=432)-identical placebo, for 2 oral doses, 3.5 months apart. Co-intervention
      with asthma therapy (preventive or pre-emptive ICS) will be left to the discretion of the
      physician and documented. Children will be followed every 3.5 months as per usual practice,
      with a home visit 10 days after each bolus, during which urine and blood will be sampled for
      urinary calcium:creatinine ratio, serum vitamin D, markers of calcium metabolism, and
      mechanistic exploration. A validated diary will serve to document the intensity and severity
      of exacerbations. In two sites, preschool lung function will be documented (if ≥ 3yrs).
      Outcomes: Primary endpoint-number of exacerbations requiring rescue oral corticosteroids
      (OCS) per child, documented by medical and pharmacy records. Secondary outcomes: duration and
      severity of exacerbations (symptoms & β2-agonist use, by diary; emergency visits, by medical
      records), parental functional status (by validated instrument), asthma therapy
      intensification and health care and direct costs (by health records & parent reports).
      Safety, mechanistic, exploratory outcomes: hypercalciuria, calcium metabolism, excess vitamin
      D, change in serum gene expression at 10 days (first 25 patients); and change from baseline
      at 7 months in preschool lung function (2 sites). Based on 3 published RCTs, a sample of 432
      per arm (400+7.5% attrition) will provide 80% power (2-tailed alpha of 5%) to detect a 25%
      reduction in number of exacerbations requiring OCS/child (0.55 vs. 0.4125).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change from baseline in serum 25OHD
time frame: During the 7-month follow-up period
description: Group difference in the adjusted change from baseline 25OHD over time and specifically at 3.5 and 7 months
measure: Proportion of children with total 25OHD ≥75 nmol/L
time frame: at 3.5 and 7 months
description: Group difference in the proportion of children with total 25OHD ≥75 nmol/L
measure: Hypercalciuria
time frame: At any point during the 7-month follow-up period
description: Group difference in the proportion of children with ≥1 occurrence of hypercalciuria (urinary calcium: creatinine greater than 1.25mmol/mmol for children aged 1-2yrs (or greater than 1mmol/mmol for those aged 2-5yrs)
measure: Elevated serum 25-hydroxyvitamin D (25OHD)
time frame: At any point during the 7-month follow-up period
description: Proportion of children with ≥1 occurrence of elevated serum 25OHD (greater than 250nmol/L)
measure: Perturbation of the calcium homeostasis
time frame: At any point during the 7-month follow-up period
description: Proportion of children with ≥1 occurrence of a perturbation of the calcium homeostasis (serum Ca, Ph, Alkaline phosphatase), defined as outside normal laboratory values
measure: RNA expression
time frame: Over the 7 months after the intial dose of Vit D/Placebo
description: Group difference in the change from baseline in RNA expression measured between 0, 10 days, 3.5 months and 7 months post initial dose of Vit D/Placebo
measure: Duration of URTIs
time frame: During an URTI during the 7-month follow-up period
description: Group difference in the duration of URTI as documented by parents at the end of each episode
measure: Viral upper respiratory tract infections (URTI)
time frame: During the 7-month follow-up period
description: Group difference in the number of reported viral upper respiratory tract infections
measure: Emergency department visit for an asthma flare-up
time frame: During the 7-month follow-up period
description: Group difference in the number of emergency department visits for asthma
measure: Rescue β2-agonist use during an asthma flare-up
time frame: During the 7-month follow-up period
description: Group difference in the cumulative daily use of rescue β2-agonist use as documented by parents on the 'Asthma Flare-up Diary for Young CHildren' during a URTI or an asthma exacerbation
measure: Severity of asthma symptoms during an asthma flare-up
time frame: During an URTI or flare-up during the 7-month follow-up period
description: Group difference in the severity on the asthma symptoms documented as the sum of daily score on the 'Asthma FLare-up DIary for Young Children' questionnaire
measure: Duration of asthma symptoms during a flare-up
time frame: During an URTI or flare-up during the 7-month follow-up period
description: Group difference in the duration of asthma symptoms documented on the 'Asthma FLare-up DIary for Young Children' questionnaire
measure: Exacerbations requiring rescue oral corticosteroids
time frame: During the 7-month follow-up period
description: Mean group rate of exacerbations requiring rescue oral corticosteroids/child
measure: Patients with exacerbations requiring rescue oral corticosteroids
time frame: During the 7-month follow-up period
description: Proportion of children with ≥1 exacerbation requiring rescue oral corticosteroids
measure: Impact of exacerbations on caregivers' functional status
time frame: During an URTI or flare-up during the 7-month follow-up period
description: Group difference in the caregivers' functional status measured on the 'Effect of a child's asthma flare-up on parents' questionnaire
measure: Impact of exacerbations on caregivers' workday lost
time frame: During an URTI or flare-up during the 7-month follow-up period
description: Group difference in the caregivers' number of workday lost
arm group label: Placebo
arm group type: Placebo Comparator
description: 2 ml identical placebo taken by mouth at baseline and 3.5 months.
arm group label: Vitamin D
arm group type: Active Comparator
description: Vitamin D (100,000IU) given in a 2 ml oral dose at baseline and 3.5months.
intervention type: Dietary Supplement
intervention name: vitamin D
description: Two doses of cholecalciferol 100,000 unit (2 mL) given 3.5 months apart, once in the fall, once in the winter
arm group label: Vitamin D
other name: cholecalciferol
intervention type: Dietary Supplement
intervention name: placebo
description: Two doses of identical placebo (2 mL) given 3.5 months part, once in the fall, once in the winter
arm group label: Placebo
criteria: 
gender: All
minimum age: 1 Year
maximum age: 5 Years
healthy volunteers: No
last name: Francine M Ducharme, MD
role: Principal Investigator
affiliation: St. Justine's Hospital
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: St. Justine's Hospital
investigator full name: Professor Francine Ducharme
investigator title: Principal Investigator
mesh term: Asthma
mesh term: Vitamin D
mesh term: Cholecalciferol
sharing ipd: Undecided
submitted: November 19, 2020
returned: December 16, 2020
submitted: March 16, 2022
returned: July 15, 2022
submitted: April 18, 2023