<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/NCT04502667</url>
  </required_header>
  <id_info>
    <org_study_id>R-2020-3603-020</org_study_id>
    <nct_id>NCT04502667</nct_id>
  </id_info>
  <brief_title>Efficacy of Vitamin D Treatment in Pediatric Patients Hospitalized by COVID-19</brief_title>
  <acronym>COVID-19</acronym>
  <official_title>Efficacy of Vitamin D Treatment in Pediatric Patients Hospitalized by COVID-19: Open Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Coordinación de Investigación en Salud, Mexico</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hospital Infantil de Mexico Federico Gomez</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital General de México Dr. Eduardo Liceaga</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Coordinación de Investigación en Salud, Mexico</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Open controlled clinical trial. Hospitalized pediatric patients with COVID-19 will be&#xD;
      included. Upon admission to hospital serum determination of vitamin D, interleukins, ferritin&#xD;
      and Dimer D will be performed. Subsequently, randomization will be performed to identify&#xD;
      which group the patient belongs. Adverse effects will be evaluated on a daily basis. Serum&#xD;
      levels of interleukin (IL) -2, 6, 7,10, ferritin and dimer-D will be taken at the beginning&#xD;
      of hospitalization and on the 7th day after admission. It will be recorded if the patient&#xD;
      presents deterioration of the respiratory function that requires endotracheal intubation and&#xD;
      / or admission to intensive care and / or if he dies, and at what time of hospitalization&#xD;
      does this outcome occur. The study will culminate when the patient is discharged from&#xD;
      hospitalization.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hospitalized pediatric patients with COVID-19 will be included. The diagnosis of COVID-19&#xD;
      performed through RT-PCR. Upon admission to hospital, a serum determination of Vitamin D,&#xD;
      interleukins, ferritin and dimer-D will be performed. Subsequently, randomization will be&#xD;
      performed to identify which group the patient belongs to. In case of being in the vitamin D&#xD;
      group, in children under 12 months they will be given 1000U and in children over 12 months&#xD;
      they will be given 2000U every 24 hours orally. Adverse effects will be evaluated on a daily&#xD;
      basis. Subsequently, serum levels of interleukin (IL) -2, 6, 7,10, ferritin and dimer-D will&#xD;
      be taken on day 7 of admission. It will be recorded if the patient presents deterioration of&#xD;
      the respiratory function that requires endotracheal intubation and / or admission to&#xD;
      intensive care and / or if he dies, and at what time of hospitalization does this outcome&#xD;
      occur. The study will culminate when the patient is discharged from hospitalization. On the&#xD;
      day of hospital discharge, a blood sample will be taken to determine vitamin D.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 15, 2020</start_date>
  <completion_date type="Actual">September 15, 2021</completion_date>
  <primary_completion_date type="Actual">March 31, 2021</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>
    <intervention_model_description>Open controlled clinical trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>INTERLEUKINS (IL-2,6,7,10) (pg/ml)</measure>
    <time_frame>7 days</time_frame>
    <description>Taken on admission of the patient to hospitalization (through venipuncture measured by an in-vitro diagnostic enzyme immunoassay (ELISA) for quantitative determination) and on day 7 of hospitalization.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>FERRITIN (ng/ml)</measure>
    <time_frame>7 days</time_frame>
    <description>Taken on admission of the patient to hospitalization (through venipuncture measured by an in-vitro diagnostic enzyme immunoassay (ELISA) for quantitative determination) and on day 7 of hospitalization.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>DIMER-D</measure>
    <time_frame>7 days</time_frame>
    <description>Taken on admission of the patient to hospitalization (through venipuncture measured by an in-vitro diagnostic enzyme immunoassay (ELISA) for quantitative determination) and on day 7 of hospitalization.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Vitamin D (ng/ml)</measure>
    <time_frame>the beginning and through study completion, an average of 21 days</time_frame>
    <description>determination of 25-hydroxy-Vitamin D in human serum</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Covid19</condition>
  <condition>Vitamin D</condition>
  <condition>Children, Only</condition>
  <arm_group>
    <arm_group_label>cholecalciferol (Vitamin D)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Children under 12 months they will be given 1000U and in children over 12 months they will be given 2000U every 24 hours orally during hospitalization</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cholecalciferol</intervention_name>
    <description>1000U or 2000U every 24 hours orally</description>
    <arm_group_label>cholecalciferol (Vitamin D)</arm_group_label>
    <other_name>vitamin D</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria&#xD;
&#xD;
          1. Age over 1 month and under 17 years&#xD;
&#xD;
          2. Confirmed diagnosis of COVID-19 infection with the results of real-time PCR&#xD;
&#xD;
          3. That they agreed to participate in the study.&#xD;
&#xD;
          4. That the patient tolerates the enteral route&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
        1. Have received vitamin D in the four weeks prior to hospitalization.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>JESSIE ZURITA-CRUZ</last_name>
    <role>Principal Investigator</role>
    <affiliation>Coordinación de Investigación en Salud, Mexico</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Centro Medico Nacional Siglo XXI</name>
      <address>
        <city>Mexico City</city>
        <state>Distrito Federal</state>
        <zip>06720</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>August 4, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>April 7, 2022</last_update_submitted>
  <last_update_submitted_qc>April 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Coordinación de Investigación en Salud, Mexico</investigator_affiliation>
    <investigator_full_name>Jessie Nallelly Zurita Cruz</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</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>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/NCT04502667
org study id: R-2020-3603-020
nct id: NCT04502667
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Open controlled clinical trial. Hospitalized pediatric patients with COVID-19 will be
      included. Upon admission to hospital serum determination of vitamin D, interleukins, ferritin
      and Dimer D will be performed. Subsequently, randomization will be performed to identify
      which group the patient belongs. Adverse effects will be evaluated on a daily basis. Serum
      levels of interleukin (IL) -2, 6, 7,10, ferritin and dimer-D will be taken at the beginning
      of hospitalization and on the 7th day after admission. It will be recorded if the patient
      presents deterioration of the respiratory function that requires endotracheal intubation and
      / or admission to intensive care and / or if he dies, and at what time of hospitalization
      does this outcome occur. The study will culminate when the patient is discharged from
      hospitalization.
Hospitalized pediatric patients with COVID-19 will be included. The diagnosis of COVID-19
      performed through RT-PCR. Upon admission to hospital, a serum determination of Vitamin D,
      interleukins, ferritin and dimer-D will be performed. Subsequently, randomization will be
      performed to identify which group the patient belongs to. In case of being in the vitamin D
      group, in children under 12 months they will be given 1000U and in children over 12 months
      they will be given 2000U every 24 hours orally. Adverse effects will be evaluated on a daily
      basis. Subsequently, serum levels of interleukin (IL) -2, 6, 7,10, ferritin and dimer-D will
      be taken on day 7 of admission. It will be recorded if the patient presents deterioration of
      the respiratory function that requires endotracheal intubation and / or admission to
      intensive care and / or if he dies, and at what time of hospitalization does this outcome
      occur. The study will culminate when the patient is discharged from hospitalization. On the
      day of hospital discharge, a blood sample will be taken to determine vitamin D.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Open controlled clinical trial
primary purpose: Treatment
masking: None (Open Label)
measure: INTERLEUKINS (IL-2,6,7,10) (pg/ml)
time frame: 7 days
description: Taken on admission of the patient to hospitalization (through venipuncture measured by an in-vitro diagnostic enzyme immunoassay (ELISA) for quantitative determination) and on day 7 of hospitalization.
measure: FERRITIN (ng/ml)
time frame: 7 days
description: Taken on admission of the patient to hospitalization (through venipuncture measured by an in-vitro diagnostic enzyme immunoassay (ELISA) for quantitative determination) and on day 7 of hospitalization.
measure: DIMER-D
time frame: 7 days
description: Taken on admission of the patient to hospitalization (through venipuncture measured by an in-vitro diagnostic enzyme immunoassay (ELISA) for quantitative determination) and on day 7 of hospitalization.
measure: Vitamin D (ng/ml)
time frame: the beginning and through study completion, an average of 21 days
description: determination of 25-hydroxy-Vitamin D in human serum
arm group label: cholecalciferol (Vitamin D)
arm group type: Experimental
description: Children under 12 months they will be given 1000U and in children over 12 months they will be given 2000U every 24 hours orally during hospitalization
arm group label: Control
arm group type: No Intervention
description: No intervention
intervention type: Drug
intervention name: Cholecalciferol
description: 1000U or 2000U every 24 hours orally
arm group label: cholecalciferol (Vitamin D)
other name: vitamin D
criteria: 
gender: All
minimum age: 1 Month
maximum age: 17 Years
healthy volunteers: No
last name: JESSIE ZURITA-CRUZ
role: Principal Investigator
affiliation: Coordinación de Investigación en Salud, Mexico
facility: 
country: Mexico
responsible party type: Principal Investigator
investigator affiliation: Coordinación de Investigación en Salud, Mexico
investigator full name: Jessie Nallelly Zurita Cruz
investigator title: principal investigator
mesh term: COVID-19
mesh term: Vitamin D
mesh term: Cholecalciferol
sharing ipd: No