<?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>IRCT20221211056777N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-04-03</date_registration>
      <primary_sponsor>Shahre-kord University of Medical Sciences</primary_sponsor>
      <public_title>Effect of coenzyme Q10 supplement to decrease cardiac complications in β-Thalassemia major patients</public_title>
      <acronym></acronym>
      <scientific_title>Effect of coenzyme Q10 supplement to decrease cardiac complications predictor factors in β-Thalassemia major patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-04-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72654</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Supportive.</study_design>
      <phase>3</phase>
      <hc_freetext>Beta Thalassemia major.</hc_freetext>
      <i_freetext>50 individuals with major thalassemia will be selected. Laboratory parameters (Troponin, D-dimer, Nt-proBNP, EF, PAP) will be examined initially and recorded along with demographic information in a checklist made by the researcher. Along with standard treatment (iron chelators such as deferoxamine, deferasirox, etc) they will also receive a daily dose of 100mg of Co-enzyme Q10 tablets (Golden Life) for eight weeks. After the eight weeks of medication, the parameters will be examined again..</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:
To share the data and documents of this research, only the information related to the main outcome will be shared. Also, files that can be published and do not violate people's privacy will be published.

When:
The access period will start 6 months after the results are published.

To whom:
Our data will only be available to researchers working in academic and scientific institutions.

Conditions:
If there are conditions, all our data will be shared except personal information of people. The use of our data will only be allowed for similar research and review of our data by other researchers. All those who work in universities and scientific centers and decide to conduct similar research or check the accuracy of our data can access our data.

Where to obtain:
In order to receive information, all eligible people can collect data by referring to the person in charge of the project. The contact methods are the email address nimanimanimana@gmail.com or the contact number 00989140868595.

How to obtain:
To receive information after sending the request, the requests will be reviewed within 10 days. If the above conditions are met, the information will be sent to the provided email within 30 days at most.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nima Asgar dehkordi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 7, 17th Ave., 17 shahrivar st.</address>
        <city>Shahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8815917533</zip>
        <telephone>+98 38 3333 7728</telephone>
        <email>nimanimanimana@gmail.com</email>
        <affiliation>Shahre-kord University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nima Asgar dehkordi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 7, 17th Ave., 17 shahrivar st.</address>
        <city>Shahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8815917533</zip>
        <telephone>+98 38 3333 7728</telephone>
        <email>nimanimanimana@gmail.com</email>
        <affiliation>Shahre-kord University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Beta Thalassemia major
Informed consent to participate in the intervention
No history of underlying disease
Not to use other supplements</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnancy or breastfeeding</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>D56.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Beta thalassemia</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>50 individuals with major thalassemia will be selected. Laboratory parameters (Troponin, D-dimer, Nt-proBNP, EF, PAP) will be examined initially and recorded along with demographic information in a checklist made by the researcher. Along with standard treatment (iron chelators such as deferoxamine, deferasirox, etc) they will also receive a daily dose of 100mg of Co-enzyme Q10 tablets (Golden Life) for eight weeks. After the eight weeks of medication, the parameters will be examined again.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Blood quantitative Troponin level. Timepoint: Before the intervention and eight weeks after the intervention. Method of measurement: Biochemical laboratory kit.</prim_outcome>
      <prim_outcome>Blood N-terminal prohormone of brain natriuretic peptide (Nt-proBNP) level. Timepoint: Before the intervention and eight weeks after the intervention. Method of measurement: Biochemical laboratory kit.</prim_outcome>
      <prim_outcome>Blood D-dimer level. Timepoint: Before the intervention and eight weeks after the intervention. Method of measurement: Biochemical laboratory kit.</prim_outcome>
      <prim_outcome>Cardiac ejection fraction (EF). Timepoint: Before the intervention and eight weeks after the intervention. Method of measurement: Echocardiography.</prim_outcome>
      <prim_outcome>Pulmonary artery pressure (PAP). Timepoint: Before the intervention and eight weeks after the intervention. Method of measurement: Echocardiography.</prim_outcome>
      <prim_outcome>Left ventricle end diastolic diameter (LVDD). Timepoint: Before the intervention and eight weeks after the intervention. Method of measurement: Echocardiography.</prim_outcome>
      <prim_outcome>Left ventricle end systolic diameter (LVDS). Timepoint: Before the intervention and eight weeks after the intervention. Method of measurement: Echocardiography.</prim_outcome>
      <prim_outcome>Pulsed wave (PW). Timepoint: Before the intervention and eight weeks after the intervention. Method of measurement: Echocardiography.</prim_outcome>
      <prim_outcome>Interventricular septum thickness (IVSd). Timepoint: Before the intervention and eight weeks after the intervention. Method of measurement: Echocardiography.</prim_outcome>
      <prim_outcome>Left atrium diameter (LA). Timepoint: Before the intervention and eight weeks after the intervention. Method of measurement: Echocardiography.</prim_outcome>
      <prim_outcome>Aorta diameter (Ao). Timepoint: Before the intervention and eight weeks after the intervention. Method of measurement: Echocardiography.</prim_outcome>
      <prim_outcome>Right ventricular dysfunction (RVD). Timepoint: Before the intervention and eight weeks after the intervention. Method of measurement: Echocardiography.</prim_outcome>
      <prim_outcome>Right ventricular peak systolic myocardial velocity (RVSm). Timepoint: Before the intervention and eight weeks after the intervention. Method of measurement: Echocardiography.</prim_outcome>
      <prim_outcome>Tricuspid Annular Plane Systolic Excursion (TAPSE). Timepoint: Before the intervention and eight weeks after the intervention. Method of measurement: Echocardiography.</prim_outcome>
      <prim_outcome>Tricuspid regurgitation gradient (TRG). Timepoint: Before the intervention and eight weeks after the intervention. Method of measurement: Echocardiography.</prim_outcome>
      <prim_outcome>Aortic valve pressure gradient (AVPG). Timepoint: Before the intervention and eight weeks after the intervention. Method of measurement: Echocardiography.</prim_outcome>
      <prim_outcome>P wave characteristics. Timepoint: Before the intervention and eight weeks after the intervention. Method of measurement: Electrocardiography.</prim_outcome>
      <prim_outcome>PR interval. Timepoint: Before the intervention and eight weeks after the intervention. Method of measurement: Electrocardiography.</prim_outcome>
      <prim_outcome>QRS wave characteristics. Timepoint: Before the intervention and eight weeks after the intervention. Method of measurement: Electrocardiography.</prim_outcome>
      <prim_outcome>ST segment characteristics. Timepoint: Before the intervention and eight weeks after the intervention. Method of measurement: Electrocardiography.</prim_outcome>
      <prim_outcome>QT interval. Timepoint: Before the intervention and eight weeks after the intervention. Method of measurement: Electrocardiography.</prim_outcome>
      <prim_outcome>T wave characteristics. Timepoint: Before the intervention and eight weeks after the intervention. Method of measurement: Electrocardiography.</prim_outcome>
      <prim_outcome>Heart Axis. Timepoint: Before the intervention and eight weeks after the intervention. Method of measurement: Electrocardiography.</prim_outcome>
      <prim_outcome>ECG Rhythm. Timepoint: Before the intervention and eight weeks after the intervention. Method of measurement: Electrocardiography.</prim_outcome>
      <prim_outcome>Heart Rate. Timepoint: Before the intervention and eight weeks after the intervention. Method of measurement: Electrocardiography.</prim_outcome>
      <prim_outcome>Peak velocity of early diastolic transmitral flow (E). Timepoint: Before the intervention and eight weeks after the intervention. Method of measurement: Echocardiography.</prim_outcome>
      <prim_outcome>Peak velocity of early diastolic mitral annular motion (E'). Timepoint: Before the intervention and eight weeks after the intervention. Method of measurement: Echocardiography.</prim_outcome>
      <prim_outcome>Passive blood flow from the left atrium to the left ventricle (E wave). Timepoint: Before the intervention and eight weeks after the intervention. Method of measurement: Echocardiography.</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>Shahre-kord University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-11-27</approval_date>
        <contact_name>Ethics committee of Shahrekord University of Medical Science</contact_name>
        <contact_address>Kashani street Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
