<?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>IRCT20190610043857N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-06-30</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Effect of nutrition education on the status of iron deficiency anemia</public_title>
      <acronym></acronym>
      <scientific_title>Evaluating the effect of digital game-based nutrition education on iron deficiency anemia indicators in adolescent girls</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>176</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40182</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomized balanced block:

Eligible people will be randomly assigned into  two groups: randomized block randomization will be done with a fixed block size of four.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Iron deficiency anemia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group :Adolescent girl in the intervention group will participate in a nutrition education program using an online game for The 14 weeks. The computer game is consisted of seven different levels, in which each level will be opened every single week for students, so that the whole game will be played during the 14 weeks. Intervention 2: control group :Girls in the control group will receive only nutritional recommendations for iron deficiency anemia through PowerPoint and  Pamphlet.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is before publishing the article, we don't agree to share our results with others.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Omid sabetghadam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nutrition and Food Sciences of Shiraz, Razi street, Modares Blvd.</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7153675541</zip>
        <telephone>+98 71372510015</telephone>
        <email>sayans194@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Sohrabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nutrition and Food Sciences of Shiraz, Razi street, Modares Blvd</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7153675541</zip>
        <telephone>+98 71372510015</telephone>
        <email>Zahra_2043@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Adolescent girls (19-10 years old) who can use smart phones</inclusion_criteria>
      <agemin>10 years</agemin>
      <agemax>19 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Having Cardiovascular disease or other chronic diseases
Severe monthly bleeding during menstruation
Having Infection or Fractures
Students who have been treated with iron supplements or other vitamin or mineral supplements during the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>D50</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Iron deficiency anemia</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group :Adolescent girl in the intervention group will participate in a nutrition education program using an online game for The 14 weeks. The computer game is consisted of seven different levels, in which each level will be opened every single week for students, so that the whole game will be played during the 14 weeks</i_keyword>
      <i_keyword>control group :Girls in the control group will receive only nutritional recommendations for iron deficiency anemia through PowerPoint and  Pamphlet.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Ferritin. Timepoint: Baseline and after 14 weeks of intervention. Method of measurement: ELISA method.</prim_outcome>
      <prim_outcome>Transferrin. Timepoint: Baseline and after 14 weeks of intervention. Method of measurement: Calorimetry.</prim_outcome>
      <prim_outcome>Hemoglobin. Timepoint: Baseline and after 14 weeks of intervention. Method of measurement: Cell counter.</prim_outcome>
      <prim_outcome>Serum Iron. Timepoint: Baseline and after 14 weeks of intervention. Method of measurement: Calorimetry.</prim_outcome>
      <prim_outcome>Total Iron Binding Capacity (TIBC). Timepoint: Baseline and after 14 weeks of intervention. Method of measurement: Calorimetry.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Score of knowledge. Timepoint: Baseline and after 14 weeks of intervention. Method of measurement: Questionnaire on Knowledge of Adolescent Girls about Iron Deficiency Anemia.</sec_outcome>
      <sec_outcome>Height. Timepoint: Baseline and after 14 weeks of intervention. Method of measurement: Stadiometer.</sec_outcome>
      <sec_outcome>Weight. Timepoint: Baseline and after 14 weeks of intervention. Method of measurement: Digital scale.</sec_outcome>
      <sec_outcome>Score of attitude. Timepoint: Baseline and after 14 weeks of intervention. Method of measurement: Questionnaire on attitude of adolescent girls about iron deficiency anemia.</sec_outcome>
      <sec_outcome>Score of performance. Timepoint: Baseline and after 14 weeks of intervention. Method of measurement: Questionnaire on the performance of adolescent girls about iron deficiency anemia.</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-10-27</approval_date>
        <contact_name>Ethics committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Center building of Shiraz University of Medical Sciences , infront of felestin street, zand avenue, Shiraz. Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
