<?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>IRCT20201107049296N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-08-19</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the effect of oral L-Carnitine on liver enzymes in children diagnosed with ALL</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effect of oral L-Carnitine on liver enzymes in children diagnosed with ALL in the maintenance phase of therapy: A randomized clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-09-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>98</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72097</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, the stratified block randomization method will be used using blocks with a size of 4 and stratified according to age. We will use the site https://www.sealedenvelope.com to provide random sequences. For the sequence concealment, it will be given to an independent individual and will be revealed case by case to the project researcher in coded form with A and B labels, Blinding description: Blinding will be done using a placebo syrup identical in form to the original drug. Allocation between the groups is done based on the coded labels A and B on the glass of syrups, and only the independent person responsible for coding is aware of the type of labels.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Acute lymphoblastic leukaemia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: L-carnitine syrup (َAlborz pharmaceutical company, Iran) with a dose of 50 mg/Kg will be given in three  times a day every 8 hours for a period of two months. The chemotherapy protocol will be weekly methotrexate at a dose of 20 mg/m2 (body surface) and 6 mercaptopurine daily at a dose of mg/m2 (body surface). Intervention 2: Control group: A placebo of the same shape and color in the same package as the intervention drugs (َAlborz pharmaceutical company, Iran) will be used in three divided doses every 8 hours for a period of two months. The chemotherapy protocol will be weekly methotrexate at a dose of 20 mg/m2 (body surface) and 6 mercaptopurine daily at a dose of mg/m2 (body surface).</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 Ownership of the data rests with the study sponsor.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Aziz Eghbali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Aliasghar children’s hospital, Dastgerdi st., Zafar st., Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1919816766</zip>
        <telephone>+98 21 2268 8027</telephone>
        <email>eghbali.a@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Aziz Eghbali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Aliasghar children’s hospital, Dastgerdi st., Zafar st., Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1919816766</zip>
        <telephone>+98 21 2268 8027</telephone>
        <email>eghbali.a@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Children with acute lymphoblastic leukemia (ALL)
Age between 5 and 18 years
In maintenance phase of chemotherapy (under treatment with methotrexate and 6-mercaptopurine)
The serum level of liver enzymes between two and a half to ten times normal
Total bilirubin between 1.5 and 3 mg/dL
Gamma glutamyl transferase (GGT) serum level greater than or equal to 60
Parental informed consent to participate in the trial</inclusion_criteria>
      <agemin>5 years</agemin>
      <agemax>18 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having viral hepatitis, including A, B and C
Active infection with any of the Epstein-Barr viruses, Cytomegalovirus, herpes simplex
Active bacterial infection
Any type of underlying liver dysfunction
Renal dysfunction is defined by a creatinine number higher than 2 times the upper normal level
Taking aspirin
Contracting AIDS
Current Hypothyroidism
History of epilepsy
Sickle cell anemia
Suffering from malabsorption disorders</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C91.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acute lymphoblastic leukaemia</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Surgery</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: L-carnitine syrup (َAlborz pharmaceutical company, Iran) with a dose of 50 mg/Kg will be given in three  times a day every 8 hours for a period of two months. The chemotherapy protocol will be weekly methotrexate at a dose of 20 mg/m2 (body surface) and 6 mercaptopurine daily at a dose of mg/m2 (body surface).</i_keyword>
      <i_keyword>Control group: A placebo of the same shape and color in the same package as the intervention drugs (َAlborz pharmaceutical company, Iran) will be used in three divided doses every 8 hours for a period of two months. The chemotherapy protocol will be weekly methotrexate at a dose of 20 mg/m2 (body surface) and 6 mercaptopurine daily at a dose of mg/m2 (body surface).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Serum level of alanine transaminase (ALT). Timepoint: 4, 6, 8, 10 and 12 weeks after the intervention. Method of measurement: Serum spectrophotometry.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Aspartate transferase (AST) serum level. Timepoint: 4, 6, 8, 10 and 12 weeks after the intervention. Method of measurement: Serum Spectrophotometry.</sec_outcome>
      <sec_outcome>Blood serum bilirubin level. Timepoint: 4, 6, 8, 10 and 12 weeks after the intervention. Method of measurement: Serum spectrophotometry.</sec_outcome>
      <sec_outcome>Serum alkaline phosphatase level. Timepoint: 4, 6, 8, 10 and 12 weeks after the intervention. Method of measurement: Serum spectrophotometry.</sec_outcome>
      <sec_outcome>Blood platelet count. Timepoint: 4, 6, 8, 10 and 12 weeks after the intervention. Method of measurement: Cell counter.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-01-28</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Iran university of medical science., Next to Milad Tower., Hemmat Highway., Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
