<?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>IRCT20171222037986N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-08-01</date_registration>
      <primary_sponsor>Sanandaj University of Medical Sciences</primary_sponsor>
      <public_title>The role of vitamin D in the course of asthma</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the vitamin D supplementation effect on the course of asthma</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-03-13</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>52</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/30252</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>asthma.</hc_freetext>
      <i_freetext>According to the Approved guideline by the Northamptonshire Prescribing Advisory Group, the treatment of vitamin D deficiency: patients with deficiency of vitamin D (&lt;25nmol/l): At the primary care level the Fultium-D3 800IU capsule, 4 capsules daily for 84 days (12 weeks) At the second care level, D3-50 50,000 IU, one tablet daily for 6 days or Cholecalciferol 300,000 units can be injected intramuscular monthly for 3 months For patients with insufficiency of vitamin D (25-50 nmol/l), according to the patient's calcium level and according to the physician opinion. the clinic of Besat Hospital of Sanandaj.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
All data is from the proposal, raw data and project reports

When:
Data is available from the legal system six months after publication for two years

To whom:
All persons will be able to access the Kurdistan University of Medical Sciences's request to the Kurdistan University of Medical Sciences.

Conditions:
For legal issues and the need to use data in future studies

Where to obtain:
By submitting a request to the Delegation for Research and Technology and approving the Ethics Committee - Rasoul Nasiri Kalmarzi MD

How to obtain:
After submitting a request to the Kurdistan Research and Technology Dept. of Science and Technology, a call for submission is given.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Saywan Ahmadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kurdistan University of Medical Sciences,  Pasdaran St., Sanandaj, Iran</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6618634683</zip>
        <telephone>+98 87 3366 4645</telephone>
        <email>saywanahmadi1992@gmail.com</email>
        <affiliation>Sanandaj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Rasoul Nasiri Kalmarzi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kurdistan University of Medical Sciences, Pasdaran St., Sanandaj, Iran</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6618634683</zip>
        <telephone>+98 87 3323 0524</telephone>
        <email>rasool_nsr@yahoo.com</email>
        <affiliation>Sanandaj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients diagnosed with asthma based on history and physical examination or PFT findings.
Willing to participate in the study
No previous disease are known.
Vitamin D Deficiency</inclusion_criteria>
      <agemin>6 years</agemin>
      <agemax>18 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The person's unwillingness to continue to collaborate on the study
Recognition of any disorder or chronic illness during the study (including kidney or liver disease)
Malignancy
Musculoskeletal disorders including rickets and osteomalacia
Taking vitamin D 'as a medicine or a nutritional supplement
Use of drugs that may have an effect on vitamin D metabolism, including anticonvulsants
The normal level of vitamin D after measuring its serum levels</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J45</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Asthma</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>According to the Approved guideline by the Northamptonshire Prescribing Advisory Group, the treatment of vitamin D deficiency: patients with deficiency of vitamin D (&lt;25nmol/l): At the primary care level the Fultium-D3 800IU capsule, 4 capsules daily for 84 days (12 weeks) At the second care level, D3-50 50,000 IU, one tablet daily for 6 days or Cholecalciferol 300,000 units can be injected intramuscular monthly for 3 months For patients with insufficiency of vitamin D (25-50 nmol/l), according to the patient's calcium level and according to the physician opinion. the clinic of Besat Hospital of Sanandaj</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Asthma severity. Timepoint: 12 weeks. Method of measurement: based on examinations, PFT and History tacking.</prim_outcome>
      <prim_outcome>Exacerbation. Timepoint: Upon arrival  to 12 weeks later. Method of measurement: Coughing attacks, shortness of breath and wheezing caused by exacerbation of asthma.</prim_outcome>
      <prim_outcome>FEV1. Timepoint: Coming in and 12 weeks later. Method of measurement: Spirograph chart.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Sanandaj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-03-13</approval_date>
        <contact_name>Kurdistan University of Medical Science</contact_name>
        <contact_address>Kurdistan University of Medical Sciences Vice Chancellor in Research Affair, Pasdaran Ave., Sanandaj, Iran Sanandaj Kurdistan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
