<?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>IRCT20250416065355N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-05-14</date_registration>
      <primary_sponsor>Zahedan University of Medical Sciences</primary_sponsor>
      <public_title>Studying the  Electrocardiographic changes in patients with Iron deficiency anemia and minor thalassemia</public_title>
      <acronym>EKG</acronym>
      <scientific_title>Evaluation of Electrocardiographic Changes in Pateints WithIron Deficiency Anemia and Minor Thalassemia in Ali-Asghar Hospital in Zahedan in 2025</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>135</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/83000</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: This study is a prospective, single-blinded, controlled clinical trial designed to compare hematologic and electrocardiographic (ECG) parameters in children diagnosed with Iron Deficiency Anemia (IDA), Minor Thalassemia, and healthy Controls. A total of 135 children aged 5 to 18 years are enrolled and divided equally into three groups (n = 45 per group). Sampling is conducted using a convenient and accessible method at Ali Asghar Hospital in Zahedan. Participants are allocated to study groups based on their clinical diagnosis. The study is non-randomized; however, investigators responsible for data collection and analysis are blinded to group assignments to reduce assessment bias.Children in the IDA group receive ferrous sulfate at a dose of 5 mg/kg/day for 3 months. Those in the Minor Thalassemia group receive folic acid at a dose of 1 mg/day for 3 months. The Control group receives no pharmacological intervention. Body weight is measured monthly to adjust the dose of ferrous sulfate as needed.All participants follow a similar, age-appropriate, and healthy diet during the study. At the end of the treatment period, ECG parameters are assessed by a pediatric cardiologist who is also one of the study authors, ensuring expert and standardized evaluation, Blinding description: This study is conducted as a single-blinded trial, in which the investigators responsible for data collection and outcome assessment are blinded to group allocation. Although participants and those administering the interventions are aware of the treatment assignments, the investigators analyzing the data do not have access to group information during the evaluation phase. This approach minimizes potential assessment bias and helps ensure the objectivity and validity of the results.</study_design>
      <phase>2</phase>
      <hc_freetext>Condition 1: Iron deficiency anemia and thalassemia minor. Condition 2: Minor thalassemia.</hc_freetext>
      <i_freetext>Intervention 1: In Intervention Group 1, children aged 5 to 18 years with iron deficiency anemia were treated with ferrous sulfate. The medication was administered at a daily dose of 5 mg of elemental iron per kilogram of body weight for a duration of 3 months and was given after meals due to potential gastrointestinal side effects. Intervention 2: In Intervention Group 2, children aged 5 to 18 years with minor thalassemia were treated with folic acid. The medication was administered at a daily dose of 1 mg for a duration of 3 months.</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>Noor Mohammad Noori</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Khalij Fars BLVD, Ali Ibn Abitalib Hospital</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9816743111</zip>
        <telephone>+98 54 3329 5611</telephone>
        <email>dr_noori_cardio@yahoo.com</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Noor Mohammad Noori</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Azadi Street, Ali Asghar Hospital</address>
        <city>zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9813643353</zip>
        <telephone>+98 54 3322 9690</telephone>
        <email>Dr_noori_cardio@yahoo.com</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Children aged 5 to 18 years.
The child has minor thalassemia  or iron deficiency anemia.</inclusion_criteria>
      <agemin>5 years</agemin>
      <agemax>18 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The presence of any other underlying disease.
Other types of anemia
Using drugs that impair iron absorption
failing to adhere to regular treatment
Having  previous iron or anti-inflammatory treatments</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>D50.9</hc_code>
      <hc_code>D56.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Iron deficiency anemia, unspecified</hc_keyword>
      <hc_keyword>Thalassemia minor</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In Intervention Group 1, children aged 5 to 18 years with iron deficiency anemia were treated with ferrous sulfate. The medication was administered at a daily dose of 5 mg of elemental iron per kilogram of body weight for a duration of 3 months and was given after meals due to potential gastrointestinal side effects.</i_keyword>
      <i_keyword>In Intervention Group 2, children aged 5 to 18 years with minor thalassemia were treated with folic acid. The medication was administered at a daily dose of 1 mg for a duration of 3 months.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>ECG results. Timepoint: 3months. Method of measurement: ECG measurements (PWd, QTd, QTcd, Tp-e interval, Tp-e dispersion).</prim_outcome>
      <prim_outcome>Hemoglobin level. Timepoint: 3months. Method of measurement: compelet blood count.</prim_outcome>
      <prim_outcome>Ferritin. Timepoint: 3months. Method of measurement: Serum  Iron.</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>Zahedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-11-22</approval_date>
        <contact_name>Ethics Committee of Zahedan University of Medical Sciences</contact_name>
        <contact_address>Dr. Hesabi Square - University of Medical Sciences Campus Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
