<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20131217015835N7</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-05-17</date_registration>
      <primary_sponsor>Chancellor of Research and Technology, Zanjan University of Medical Sciences (Primary sponsor)</primary_sponsor>
      <public_title>Comparison  of the effect of Zinc and Vitamin D supplementation on Acute Bronchiolitis</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of Zinc and Vitamin  D supplementation on Acute Bronchiolitis in 2 to 23 months old children, a clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-09-27</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>135</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/14985</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple and individual randomization is chosen. Random number table is used. We will use numbers from 1 to 135 in this table and we will read these numbers from up to down and we will write the succession. Then we will give Vitamin D to numbers 1 to 45 and Zinc to numbers 46 to 90 and no drugs to numbers 91 to 135. Then for allocation concealment we will use sequentially numbered, sealed, opaque envelopes. Every one who will enter  our study will chose one envelope which has one number of the table in it and the group will be chosen for that person, Blinding description: In this trial participants and the outcome evaluators are blind. Participants know that they take supplements  besides routine drugs but instead of the name of the supplements we use  codes. The evaluators evaluate the outcomes according to the codes.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Acute bronchiolitis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: First group takes 2 mg/kg/day(max 20 mg) syrup Zinc Sulfate10  of Alhavy Company for 1 week or during hospitalization if the days of admission are less than 1 week. Intervention 2: Intervention group: Second group takes 100 unit per kg  per day drop Vitamin D (1000 IU in 1 ml) of Vitabiotic company for 1 week or during hospitalization if the days of admission are less than 1 week. Intervention 3: Control group: Third group does not take any supplements.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Parisa Khoshnevis Asl</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pediatrics department, Ayatollah Moussavi Hospital, Gavazang street, Zanjan, Iran</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4513956183</zip>
        <telephone>+98 24 3313 0000</telephone>
        <email>khoshnevis@zums.ac.ir</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Parisa Khoshnevis Asl</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pediatrics department, Ayatollah Moussavi Hospital, Gavazang street, Zanjan, Iran</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4513956183</zip>
        <telephone>+98 24 3313 0000</telephone>
        <email>khoshnevis@zums.ac.ir</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age under 2 years old
The first wheezing attack with respiratory infection
Pulse Rate less than 180
Respiratory Rate less than 100</inclusion_criteria>
      <agemin>2 months</agemin>
      <agemax>23 months</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Use of supplementary more than routine
Previous wheezing or use of bronchodilator
Prematurity
Cardiopulmonary disease
Aspiration
Neuromuscular disease
Immune deficiency
Need for mechanical ventilation
Previous use of corticostroid in 2 last weeks
Intolerancy or cuasing side effects after using the medicine</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J21.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acute bronchiolitis, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: First group takes 2 mg/kg/day(max 20 mg) syrup Zinc Sulfate10  of Alhavy Company for 1 week or during hospitalization if the days of admission are less than 1 week.</i_keyword>
      <i_keyword>Intervention group: Second group takes 100 unit per kg  per day drop Vitamin D (1000 IU in 1 ml) of Vitabiotic company for 1 week or during hospitalization if the days of admission are less than 1 week.</i_keyword>
      <i_keyword>Control group: Third group does not take any supplements.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Wheezing. Timepoint: first day,third day,and seventh day in the hospital. Method of measurement: using stethoscope.</prim_outcome>
      <prim_outcome>Respiratory rate. Timepoint: first day,third day,and seventh day in the hospital. Method of measurement: counting of chest movements.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The duration of staying in the hospital. Timepoint: first day,third day,seventh day. Method of measurement: counting the days of staying in the hospital.</sec_outcome>
      <sec_outcome>The duration of fever. Timepoint: first day,third day,seventh day. Method of measurement: thermometer.</sec_outcome>
      <sec_outcome>Percent of arterial saturation of oxygen. Timepoint: first day,third day,seventh day. Method of measurement: pulseoxymeter.</sec_outcome>
      <sec_outcome>The duration of existence of cough. Timepoint: first day,third day.seventh day. Method of measurement: asking from the patient.</sec_outcome>
      <sec_outcome>Side effects of drugs. Timepoint: first day,third day,seventh day. Method of measurement: asking from the patient and physical examination.</sec_outcome>
      <sec_outcome>The duration of cyanosis. Timepoint: first day,third day,seventh day. Method of measurement: observe the color of skin.</sec_outcome>
      <sec_outcome>The duration of respiratoty distress. Timepoint: first day,third day,seventh day. Method of measurement: observe useing of respiratory muscles which are not the main ones.</sec_outcome>
      <sec_outcome>The duration of dehydration. Timepoint: first day,third day,seventh day. Method of measurement: amount of urine out put and mucusal  dryness and skin turgor.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Chancellor of Research and Technology, Zanjan University of Medical Sciences (Primary sponsor)</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-07-23</approval_date>
        <contact_name>ethics commite of zanjan university of medical sciences</contact_name>
        <contact_address>zanjan university of medical sciences ,azadi square Zanjan Zanjan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
