<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/NCT04411901</url>
  </required_header>
  <id_info>
    <org_study_id>Original study</org_study_id>
    <nct_id>NCT04411901</nct_id>
  </id_info>
  <brief_title>The Role of Vitamin D3 in Pediatric Bronchiectasis Severity</brief_title>
  <official_title>The Role of Vitamin D3 in Pediatric Bronchiectasis Severity( CF Versus Non CF Bronchioectasis)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Heba Omara</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams University</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Vitamin D3 therapy was effective in decreasing the frequency of pulmonary exacerbations and&#xD;
      preserving lung functions , thereby improving the disease severity even more in non CF than&#xD;
      CF bronchiectasis patients&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objectives: To compare the effect of vitamin D3 on modifying the disease severity in CF and&#xD;
      non CF bronchiectasis pediatric patients.&#xD;
&#xD;
      Patients and Methods: This was a randomized clinical trial evaluating the role of oral&#xD;
      vitamin D3 supplementation for 6 months in forty patients with CF and non CF bronchiectasis&#xD;
      under the age of 18 years with vitamin D deficiency or insufficiency . The primary outcome&#xD;
      was to reach the sufficient Vitamin D level. The secondary outcome was to follow up the&#xD;
      frequency of pulmonary exacerbations and lung function after vitamin D3 supplementation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2018</start_date>
  <completion_date type="Actual">March 20, 2019</completion_date>
  <primary_completion_date type="Actual">September 6, 2018</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>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>reach sufficient vitamin D level</measure>
    <time_frame>6 months</time_frame>
    <description>vitamin D more than 30 ng/dl</description>
  </primary_outcome>
  <primary_outcome>
    <measure>decrease disease severity</measure>
    <time_frame>6 months</time_frame>
    <description>decrease excerbations and increase lung function</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Cystic Fibrosis and Non CF Bronchiectasis</condition>
  <arm_group>
    <arm_group_label>vitamin D 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>oral vitamin D3 drops and tablets</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cholecalciferol (vitaminD3)</intervention_name>
    <description>Theraputic vitamin D3 for CF and non CF bronchiectasis children</description>
    <arm_group_label>vitamin D 3</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ages less than 18 years .&#xD;
&#xD;
          -  Patients with documented diagnosis of CF (by the presence of a twice positive sweat&#xD;
             chloride test and or paired CFTR DNA genetic mutations).&#xD;
&#xD;
          -  Patients with non CF bronchiectasis diagnosed clinically and radiologically ( sweat&#xD;
             chloride test negative) with a high resolution CT-confirmed diagnosis and clinical&#xD;
             history consistent with bronchiectasis .&#xD;
&#xD;
          -  Vitamin D deficient or insufficient CF and non CF bronchiectasis patients&#xD;
&#xD;
        Exclusion Criteria: if they had&#xD;
&#xD;
          -  sufficient Vitamin D level .&#xD;
&#xD;
          -  chronic lung diseases other than CF and non CF bronchiectasis , liver or renal&#xD;
             diseases.&#xD;
&#xD;
          -  reported taking vitamin-D supplements or steroid therapy in the last 6 weeks.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Children hospital</name>
      <address>
        <city>Cairo</city>
        <state>Abbasia</state>
        <zip>02</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>May 28, 2020</last_update_submitted>
  <last_update_submitted_qc>May 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Heba Omara</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>Cystic Fibrosis</mesh_term>
    <mesh_term>Bronchiectasis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cholecalciferol</mesh_term>
    <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/NCT04411901
org study id: Original study
nct id: NCT04411901
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Vitamin D3 therapy was effective in decreasing the frequency of pulmonary exacerbations and
      preserving lung functions , thereby improving the disease severity even more in non CF than
      CF bronchiectasis patients
Objectives: To compare the effect of vitamin D3 on modifying the disease severity in CF and
      non CF bronchiectasis pediatric patients.

      Patients and Methods: This was a randomized clinical trial evaluating the role of oral
      vitamin D3 supplementation for 6 months in forty patients with CF and non CF bronchiectasis
      under the age of 18 years with vitamin D deficiency or insufficiency . The primary outcome
      was to reach the sufficient Vitamin D level. The secondary outcome was to follow up the
      frequency of pulmonary exacerbations and lung function after vitamin D3 supplementation.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: reach sufficient vitamin D level
time frame: 6 months
description: vitamin D more than 30 ng/dl
measure: decrease disease severity
time frame: 6 months
description: decrease excerbations and increase lung function
arm group label: vitamin D 3
arm group type: Experimental
description: oral vitamin D3 drops and tablets
intervention type: Drug
intervention name: Cholecalciferol (vitaminD3)
description: Theraputic vitamin D3 for CF and non CF bronchiectasis children
arm group label: vitamin D 3
criteria: 
gender: All
minimum age: 1 Year
maximum age: 17 Years
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Sponsor-Investigator
investigator affiliation: Ain Shams University
investigator full name: Heba Omara
investigator title: Principal investigator
mesh term: Cystic Fibrosis
mesh term: Bronchiectasis
mesh term: Cholecalciferol
mesh term: Vitamin D
sharing ipd: No