<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/NCT03799406</url>
  </required_header>
  <id_info>
    <org_study_id>MS/16.01.38</org_study_id>
    <nct_id>NCT03799406</nct_id>
  </id_info>
  <brief_title>Vitamin D Supplementation for Acute Bronchiolitis</brief_title>
  <official_title>Does Oral Vitamin D Supplementation in Egyptian Infants With Acute Bronchiolitis Improve the Outcome? A Double Blind Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mansoura University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mansoura University</source>
  <oversight_info>
    <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>
      This study was conducted to evaluate the effect of oral vitamin D supplementation on the&#xD;
      clinical course of acute bronchiolitis, and to investigate whether vitamin D deficiency among&#xD;
      infants who required hospital-based care for bronchiolitis is associated with the severity of&#xD;
      the acute episode.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a double blind randomized controlled trial which was conducted on 60 infants who&#xD;
      required hospital-based care for acute bronchiolitis. The patients were recruited in the&#xD;
      period from October 2018 to January 2019. Informed consents were obtained from all&#xD;
      caregivers, and approved by Institutional Research Board of our University.&#xD;
&#xD;
      The diagnosis of acute bronchiolitis was based on a first episode of respiratory distress&#xD;
      with wheezing and/ or crackles, preceded by an infection of the upper airways (rhinorrhea,&#xD;
      coryza, cough, fever). Disease severity was evaluated using Modified-Tal scoring systems for&#xD;
      bronchiolitis, since it is repeatable and can reliably be used in research and clinical&#xD;
      practice&#xD;
&#xD;
      Sample size:&#xD;
&#xD;
      Our hospital data have shown that the mean LOS for cases admitted with acute bronchiolitis&#xD;
      was 3 ± 2 days. Assuming a reduction in length of hospital stay by 50% and study power of 80%&#xD;
      to detect a clinical significance (α error) of 0.05 between interventional groups, we&#xD;
      calculated a sample size of 30 patients in each treatment group.&#xD;
&#xD;
      Randomization and Enrollment:&#xD;
&#xD;
      Patients were randomized to receive vitamin D3 treatment [100 IU/Kg/day in acute&#xD;
      bronchiolitis] (vitamin D group) or placebo (placebo group) all through the period of&#xD;
      admission as a previous cohort observational study has postulated that vitamin D daily dose&#xD;
      close to 100 IU/kg body weight is favorable for infants up to age 12 months. Both groups were&#xD;
      equal in number. Both vitamin D3 and placebo were in drop form and were identical in shape&#xD;
      and nearly the same taste and color. The assignments were kept in sealed envelopes till data&#xD;
      analysis. The randomization and allocation process were done by a higher nursing staff&#xD;
      blinded to the study. Throughout the study, the medical staff, and parents were blind to&#xD;
      assignments.&#xD;
&#xD;
      All patients were hospitalized and received treatment. The treatment consisted of intravenous&#xD;
      fluids, oxygenation, and antipyretics if needed, and nebulized hypertonic saline. Nebulized&#xD;
      adrenaline or salbutamol was added in severe cases according to the decision of a senior&#xD;
      pediatrician. The validated clinical score for acute bronchiolitis were taken after a period&#xD;
      of adjustment of at least 5 min and with the child quiet, not crying, without fever, and&#xD;
      breathing room air. Respiratory rate were determined by observation of the thoracic movement&#xD;
      over a full minute. The degree of accessory muscle use was based on the degree of intercostal&#xD;
      or subcostal retraction. Physical examination as well as clinical severity score was recorded&#xD;
      for each case at admission and every 12 hours, and at discharge. On discharge, all caregivers&#xD;
      of breastfed, partially breastfed and bottle fed infants were advised to continue vitamin D&#xD;
      supplementation at dose 400 IU per day&#xD;
&#xD;
      All patients were submitted to careful history taking, complete clinical examination and the&#xD;
      following laboratory investigations.&#xD;
&#xD;
        -  Complete blood count&#xD;
&#xD;
        -  Basal serum vitamin D3 (The 25-hydroxy vitamin D): was done before enrollment of&#xD;
           patients in the randomized trial.&#xD;
&#xD;
      Venous blood samples were collected from every subject by sterile venipuncture using&#xD;
      disposable syringes. Each sample was then distributed as follows:&#xD;
&#xD;
        1. One ml of blood was disposed into a plastic tube containing EDTA solution for performing&#xD;
           complete blood count using electronic cell counter (sysmex kx-21,Japon).&#xD;
&#xD;
        2. |Two ml blood was delivered into plain tube and centrifuged to obtain a clear non&#xD;
           hemolyzed serum which was used for performing 25 (OH) vitamin D assays. The specimens&#xD;
           were stored at - 20 until the time of the analysis. The serum 25 (OH) D levels were&#xD;
           measured using the Enzyme-Linked Immunosorbent Assay (ELISA) method.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2016</start_date>
  <completion_date type="Actual">December 1, 2018</completion_date>
  <primary_completion_date type="Actual">March 1, 2017</primary_completion_date>
  <phase>Phase 2</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>length of hospital stay</measure>
    <time_frame>3 to 5 days</time_frame>
    <description>Length of hospital stay in days</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Bronchiolitis</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>cholecalciferol at dose of 100 IU/Kg/day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cholecalciferol</intervention_name>
    <description>Therapeutic trial of vitamin D supplementation during acute episode of bronchiolitis</description>
    <arm_group_label>Intervention group</arm_group_label>
    <other_name>Vitamin D</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo supplementation during acute episode of bronchiolitis</description>
    <arm_group_label>Placebo group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Infants aged 1-24 months of age, diagnosed clinically as acute bronchiolitis and&#xD;
             presented with any of the following:&#xD;
&#xD;
               1. Persistent resting oxygen saturation below 92% in room air.&#xD;
&#xD;
               2. Marked tachypnea.&#xD;
&#xD;
               3. Intercostal retractions indicating respiratory distress.&#xD;
&#xD;
               4. Inability to maintain oral hydration.&#xD;
&#xD;
               5. Parent unable to care for child at home.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Infants with history of prematurity (&lt; 37 weeks), chronic cardiopulmonary disease,&#xD;
             immunodeficiency, neuromuscular disease, and any other chronic medical condition.&#xD;
&#xD;
          2. Patients receiving any micronutrient supplementation or therapies containing vitamin D&#xD;
             for 4 weeks prior to the study period.&#xD;
&#xD;
          3. Infants with previous episodes of wheezing or a physician's diagnosis of asthma.&#xD;
&#xD;
          4. Patients with acute bronchiolitis having very severe clinical score.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>24 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>amal osman, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mansoura University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mansoura University Children's Hospital</name>
      <address>
        <city>Mansourah</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 29, 2018</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>January 9, 2019</last_update_submitted>
  <last_update_submitted_qc>January 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mansoura University</investigator_affiliation>
    <investigator_full_name>Amal Osman</investigator_full_name>
    <investigator_title>Lecturer of Pediatrics, Mansoura University</investigator_title>
  </responsible_party>
  <keyword>Acute bronchiolitis</keyword>
  <keyword>Vitamin D</keyword>
  <keyword>Modified Tal score</keyword>
  <keyword>Randomized</keyword>
  <keyword>Controlled trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bronchiolitis</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/NCT03799406
org study id: MS/16.01.38
nct id: NCT03799406
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
This study was conducted to evaluate the effect of oral vitamin D supplementation on the
      clinical course of acute bronchiolitis, and to investigate whether vitamin D deficiency among
      infants who required hospital-based care for bronchiolitis is associated with the severity of
      the acute episode.
This is a double blind randomized controlled trial which was conducted on 60 infants who
      required hospital-based care for acute bronchiolitis. The patients were recruited in the
      period from October 2018 to January 2019. Informed consents were obtained from all
      caregivers, and approved by Institutional Research Board of our University.

      The diagnosis of acute bronchiolitis was based on a first episode of respiratory distress
      with wheezing and/ or crackles, preceded by an infection of the upper airways (rhinorrhea,
      coryza, cough, fever). Disease severity was evaluated using Modified-Tal scoring systems for
      bronchiolitis, since it is repeatable and can reliably be used in research and clinical
      practice

      Sample size:

      Our hospital data have shown that the mean LOS for cases admitted with acute bronchiolitis
      was 3 ± 2 days. Assuming a reduction in length of hospital stay by 50% and study power of 80%
      to detect a clinical significance (α error) of 0.05 between interventional groups, we
      calculated a sample size of 30 patients in each treatment group.

      Randomization and Enrollment:

      Patients were randomized to receive vitamin D3 treatment [100 IU/Kg/day in acute
      bronchiolitis] (vitamin D group) or placebo (placebo group) all through the period of
      admission as a previous cohort observational study has postulated that vitamin D daily dose
      close to 100 IU/kg body weight is favorable for infants up to age 12 months. Both groups were
      equal in number. Both vitamin D3 and placebo were in drop form and were identical in shape
      and nearly the same taste and color. The assignments were kept in sealed envelopes till data
      analysis. The randomization and allocation process were done by a higher nursing staff
      blinded to the study. Throughout the study, the medical staff, and parents were blind to
      assignments.

      All patients were hospitalized and received treatment. The treatment consisted of intravenous
      fluids, oxygenation, and antipyretics if needed, and nebulized hypertonic saline. Nebulized
      adrenaline or salbutamol was added in severe cases according to the decision of a senior
      pediatrician. The validated clinical score for acute bronchiolitis were taken after a period
      of adjustment of at least 5 min and with the child quiet, not crying, without fever, and
      breathing room air. Respiratory rate were determined by observation of the thoracic movement
      over a full minute. The degree of accessory muscle use was based on the degree of intercostal
      or subcostal retraction. Physical examination as well as clinical severity score was recorded
      for each case at admission and every 12 hours, and at discharge. On discharge, all caregivers
      of breastfed, partially breastfed and bottle fed infants were advised to continue vitamin D
      supplementation at dose 400 IU per day

      All patients were submitted to careful history taking, complete clinical examination and the
      following laboratory investigations.

        -  Complete blood count

        -  Basal serum vitamin D3 (The 25-hydroxy vitamin D): was done before enrollment of
           patients in the randomized trial.

      Venous blood samples were collected from every subject by sterile venipuncture using
      disposable syringes. Each sample was then distributed as follows:

        1. One ml of blood was disposed into a plastic tube containing EDTA solution for performing
           complete blood count using electronic cell counter (sysmex kx-21,Japon).

        2. |Two ml blood was delivered into plain tube and centrifuged to obtain a clear non
           hemolyzed serum which was used for performing 25 (OH) vitamin D assays. The specimens
           were stored at - 20 until the time of the analysis. The serum 25 (OH) D levels were
           measured using the Enzyme-Linked Immunosorbent Assay (ELISA) method.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: length of hospital stay
time frame: 3 to 5 days
description: Length of hospital stay in days
arm group label: Intervention group
arm group type: Active Comparator
description: cholecalciferol at dose of 100 IU/Kg/day
arm group label: Placebo group
arm group type: Placebo Comparator
description: placebo
intervention type: Drug
intervention name: Cholecalciferol
description: Therapeutic trial of vitamin D supplementation during acute episode of bronchiolitis
arm group label: Intervention group
other name: Vitamin D
intervention type: Other
intervention name: Placebo
description: Placebo supplementation during acute episode of bronchiolitis
arm group label: Placebo group
criteria: 
gender: All
minimum age: 1 Month
maximum age: 24 Months
healthy volunteers: No
last name: amal osman, M.D.
role: Principal Investigator
affiliation: Mansoura University
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Mansoura University
investigator full name: Amal Osman
investigator title: Lecturer of Pediatrics, Mansoura University
mesh term: Bronchiolitis
mesh term: Vitamin D
mesh term: Cholecalciferol
sharing ipd: No