<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/NCT01705314</url>
  </required_header>
  <id_info>
    <org_study_id>VitD2012</org_study_id>
    <nct_id>NCT01705314</nct_id>
  </id_info>
  <brief_title>A Randomized Trial of Vitamin D to Reduce Respiratory Infection</brief_title>
  <official_title>Effect of Vitamin D3 Supplementation to Reduce Respiratory Infections in Children and Adolescents in Vietnam: A Blinded, Placebo-controlled Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>McMaster University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>McMaster University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this study is to assess the effectiveness of vitamin D in reducing&#xD;
      laboratory-confirmed influenza and in reducing non-influenza viral respiratory tract&#xD;
      infections. A cohort of children between the ages of 3 and 17 years from the Thanh Ha&#xD;
      Commune, Thanh Liem District, Ha Nam Province, Vietnam will be randomized to either weekly&#xD;
      vitamin D supplements or placebo. Participants who develop acute respiratory infection over a&#xD;
      12-month period, will be tested for influenza, the co-primary outcome, and other respiratory&#xD;
      viruses, the other co-primary outcome, by RT-PCR.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2014</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</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>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Laboratory-confirmed non-influenza infection</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Laboratory-confirmed influenza infection</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1300</enrollment>
  <condition>Respiratory Infection</condition>
  <arm_group>
    <arm_group_label>vitamin D supplements</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>children and adolescents that are randomized to the intervention will receive 7 mls of D-drops (14,000U/week of vitamin D) for eight months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>vitamin D placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>children and adolescents that are randomized to placebo will receive 7 mls of placebo drops for eight months</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>vitamin D supplements</intervention_name>
    <description>Participants will receive 7mls of D-drops (14,000U/week of vitamin D)</description>
    <arm_group_label>vitamin D supplements</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>7mls of placebo drops per week for 8 months.</description>
    <arm_group_label>vitamin D placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Between the ages of 3 and 17&#xD;
&#xD;
          -  Residing in Thanh Liem District, Ha Nam Province, Vietnam&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Born prematurely at less than 32 weeks gestation&#xD;
&#xD;
          -  Any chronic illness (except asthma)&#xD;
&#xD;
          -  Currently using medication known to interfere with vitamin D metabolism&#xD;
&#xD;
          -  Children with a sibling participating in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mark Loeb, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>McMaster University, Hamilton, ON, Canada</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Institute of Hygiene and Epidemiology</name>
      <address>
        <city>Hanoi</city>
        <country>Vietnam</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Vietnam</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>October 9, 2012</study_first_submitted>
  <study_first_submitted_qc>October 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 12, 2012</study_first_posted>
  <last_update_submitted>October 24, 2016</last_update_submitted>
  <last_update_submitted_qc>October 24, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 26, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>human influenza children</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Respiratory Tract Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin D</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/NCT01705314
org study id: VitD2012
nct id: NCT01705314
lead sponsor: 
has dmc: No
The goal of this study is to assess the effectiveness of vitamin D in reducing
      laboratory-confirmed influenza and in reducing non-influenza viral respiratory tract
      infections. A cohort of children between the ages of 3 and 17 years from the Thanh Ha
      Commune, Thanh Liem District, Ha Nam Province, Vietnam will be randomized to either weekly
      vitamin D supplements or placebo. Participants who develop acute respiratory infection over a
      12-month period, will be tested for influenza, the co-primary outcome, and other respiratory
      viruses, the other co-primary outcome, by RT-PCR.
allocation: Randomized
intervention model: Parallel Assignment
masking: Triple (Participant, Care Provider, Investigator)
measure: Laboratory-confirmed non-influenza infection
time frame: 12 months
measure: Laboratory-confirmed influenza infection
time frame: 12 months
arm group label: vitamin D supplements
arm group type: Experimental
description: children and adolescents that are randomized to the intervention will receive 7 mls of D-drops (14,000U/week of vitamin D) for eight months
arm group label: vitamin D placebo
arm group type: Placebo Comparator
description: children and adolescents that are randomized to placebo will receive 7 mls of placebo drops for eight months
intervention type: Dietary Supplement
intervention name: vitamin D supplements
description: Participants will receive 7mls of D-drops (14,000U/week of vitamin D)
arm group label: vitamin D supplements
intervention type: Dietary Supplement
intervention name: placebo
description: 7mls of placebo drops per week for 8 months.
arm group label: vitamin D placebo
criteria: 
gender: All
minimum age: 3 Years
maximum age: 17 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mark Loeb, MD
role: Principal Investigator
affiliation: McMaster University, Hamilton, ON, Canada
facility: 
country: Vietnam
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Respiratory Tract Infections
mesh term: Vitamin D
sharing ipd: No