<?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>IRCT20230816059165N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-11-04</date_registration>
      <primary_sponsor>The University of Shiraz</primary_sponsor>
      <public_title>The Effect of Iron Supplementation on the Factors Affecting the Aerobic Capacity of Women Athletes</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Iron Supplementation on the Factors Affecting the Aerobic Capacity of Women Athletes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-06-08</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72252</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Basic scienece, Randomization description: Simple randomization method with individual randomization unit: In this way, the 14 subjects of the present study were divided into two groups of 7 by the laboratory manager without considering any specific case among them, Blinding description: In the present study, the subjects had no information about which of the two iron supplement and placebo groups they had taken, and they were kept blind in the study.
The administration of the supplement and placebo was done by the laboratory official taking into account ethical considerations, so that they knew which package contained iron and which one contained placebo, and gave iron supplement to one group and placebo to another group. Is. After this step was done, only the researcher and supervisor were informed.
The doctor in charge of the present study has also approved the permission to use iron supplements and has been involved in all stages of the work.</study_design>
      <phase>3</phase>
      <hc_freetext>The Effect of Iron Supplementation on the Factors Affecting the Aerobic Capacity of Women Athletes.</hc_freetext>
      <i_freetext>Intervention group: daily intake of 100 mg of elemental iron (one 100 mg tablet of polymaltose iron trihydroxide complex for 3 weeks), every night 1 hour before sleep.  Manufacturer: Viralian Group.</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 Because of students' unauthorized use of data and data creation through other people's data, which ultimately devalues other people's research.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ghazal Safa</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 54, Saadi St., Khajoo Crossroad., Sirjan</address>
        <city>Sirjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7814615431</zip>
        <telephone>+98 34 4220 7370</telephone>
        <email>ghazal.safa94@gmail.com</email>
        <affiliation>The University of Shiraz</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ghazal Safa</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 54, Saadi St., Khajoo Crossroad., Sirjan</address>
        <city>Sirjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7814615431</zip>
        <telephone>+98 34 4220 7370</telephone>
        <email>ghazal.safa94@gmail.com</email>
        <affiliation>The University of Shiraz</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Completing the informed consent form and having full consent to participate in the current research
Not having a variety of special and chronic diseases
Not having pain in a particular area of the body
Type and time of drug administration (if used)</inclusion_criteria>
      <agemin>16 years</agemin>
      <agemax>33 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: daily intake of 100 mg of elemental iron (one 100 mg tablet of polymaltose iron trihydroxide complex for 3 weeks), every night 1 hour before sleep.  Manufacturer: Viralian Group</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Investigating the percentage of changes and significant differences between the two studied groups in the aerobic capacity of female handball players. Timepoint: Measuring blood volume of the participants before the intervention and 21 days after consuming 100 mg of iron (a 100 mg tablet of polymaltose iron trihydroxide complex). Method of measurement: Maximum aerobic capacity, pressure perception scale, time to reach paralysis, lung ventilation and respiratory efficiency including EQO2 and EQCO2 using Bruce test and using gas analyzer (Gas Analyzer: Cortex Biophysik Germany) which will be entered manually in the treadmill data. is measured and at the end the aerobic capacities of people are calculated and recorded by the device.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>No significant difference was observed between the two studied groups in respiratory indices (Vo2max; RPE; VE; TTE; EQO2; EQCO2). Timepoint: Measuring blood volume of the participants before the intervention and 21 days after consuming 100 mg of iron (a 100 mg tablet of polymaltose iron trihydroxide complex). Method of measurement: Maximum aerobic capacity, pressure perception scale, time to reach paralysis, lung ventilation and respiratory efficiency including EQO2 and EQCO2 using Bruce test and using gas analyzer (Gas Analyzer: Cortex Biophysik Germany) which will be entered manually in the treadmill data. is measured and at the end the aerobic capacities of people are calculated and recorded by the device.</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>The University of Shiraz</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-11-09</approval_date>
        <contact_name>Shiraz University Research Ethics Committee</contact_name>
        <contact_address>No. 54, Saadi St., Khajoo Crossroad; Sirjan Sirjan Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
