<?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>IRCT20160813029327N14</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-07-17</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Assessment of Vitamin D Effectiveness on Asthma Treatment</public_title>
      <acronym></acronym>
      <scientific_title>Assessment of Vitamin D Injection Dose Adjustment on Vitamin D Deficient Asthmatic Patients Improvement and Treatment</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-10-17</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/29978</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment.</study_design>
      <phase>3</phase>
      <hc_freetext>Asthma.</hc_freetext>
      <i_freetext>Intervention group: It includes asthmatic patients with 25(OH)D3 baseline under 20 ng/ml (Vitamin D deficiency). So They need to take blood test in order to evaluate 25(OH)D3 baseline first. After they are diagnosed with Vitamin D deficiency, Vitamin D Ampoule 300,000 IU is injected to them intramuscularly(IM) once in the first month of the study and the second Vitamin D Ampoule injection, one month after the first injection, is taken again IM. Furthermore, their respiratory condition should be checked by the spirometry test and St. George's respiratory questionnaire once in the first step of the study and Then again, two months later. Moreover, another blood test two month after the first injection should be taken to see if their 25(OH)D3 baseline is corrected. Finally the results of Blood test, Spirometry test and St. George's respiratory questionnaire which were collected in the first step of the study will be compared with the ones collected after two months of follow up to see if this type of intervention is beneficial for the patients..</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 further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Mehdi Rajabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 99, Islamic Azad University of Pharmaceutical Science, Yakhchal St, Gholhak Area, Shariati Ave</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6466_19395</zip>
        <telephone>+98 21 2264 0051</telephone>
        <email>mehdirj@aol.co.uk</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hamid Reza Moezi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Damavand Avenue, Imam Hossein Square, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>17117</zip>
        <telephone>+98 21 3334 8035</telephone>
        <email>hmoezzi@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with Moderate to Severe Asthma
Under Treatment Asthmatic Patients
Vitamin D Deficient Patients</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with Infectious Lung Disease
Pregnant and Breastfeeding Women
Patients with Parathyroid Problems
Severe Kidney Disease
Severe Liver Disease</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J45</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Disorder of The Airways</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: It includes asthmatic patients with 25(OH)D3 baseline under 20 ng/ml (Vitamin D deficiency). So They need to take blood test in order to evaluate 25(OH)D3 baseline first. After they are diagnosed with Vitamin D deficiency, Vitamin D Ampoule 300,000 IU is injected to them intramuscularly(IM) once in the first month of the study and the second Vitamin D Ampoule injection, one month after the first injection, is taken again IM. Furthermore, their respiratory condition should be checked by the spirometry test and St. George's respiratory questionnaire once in the first step of the study and Then again, two months later. Moreover, another blood test two month after the first injection should be taken to see if their 25(OH)D3 baseline is corrected. Finally the results of Blood test, Spirometry test and St. George's respiratory questionnaire which were collected in the first step of the study will be compared with the ones collected after two months of follow up to see if this type of intervention is beneficial for the patients.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>25(OH)D3 Baseline. Timepoint: Assessment of 25(OH)D3 Baseline before Starting The Intervention and Again 2 Months After The First Injection of Vitamin D Ampoule. Method of measurement: Blood Test.</prim_outcome>
      <prim_outcome>Forced Expiratory Volume In First Second. Timepoint: Assessment of Forced Expiratory Volume In First Second, before Starting The Intervention and Again 2 Months After The First Injection of Vitamin D Ampoule. Method of measurement: Spirometry Device.</prim_outcome>
      <prim_outcome>Forced Vital Capacity. Timepoint: Assessment of Forced Vital Capacity, before Starting The Intervention and Again 2 Months After The First Injection of Vitamin D Ampoule. Method of measurement: Spirometry Device.</prim_outcome>
      <prim_outcome>Proportion of a Person's Vital Capacity that He Is Able to Expire in The First Second of Forced Expiration. Timepoint: Assessment of Proportion of a Person's Vital Capacity that He Is Able to Expire in The First Second of Forced Expiration, before Starting The Intervention and Again 2 Months After The First Injection of Vitamin D Ampoule. Method of measurement: Spirometry Device.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality of Life. Timepoint: Assessment of Quality of Life of The Patient before Starting The Intervention and Again 2 Months After The First Injection of Vitamin D Ampoule. Method of measurement: St. George's Respiratory Questionnaire.</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>Arian Dokht Eini Sadr</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-02-01</approval_date>
        <contact_name>Ethics Committee of Teharan Islamic Azad University of Pharmaceutical Scienses</contact_name>
        <contact_address>No 99, Yakhchal Street, Gholhak Area, Shariati Ave Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
