<?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>IRCT20201110049334N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-01-30</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of estrogen therapy on the height of children with chronic kidney disease</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of estrogen therapy on final height of short girls with chronic kidney disease (CKD) and delayed puberty</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>75</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/53097</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>3</phase>
      <hc_freetext>Short stature.</hc_freetext>
      <i_freetext>Intervention 1: ّFirst intervention group: In this group,  patients (N = 25) receive injection of growth hormone (Genotropin manufactured by Pfizer, US) from the beginning of short stature,  at the rate of 0.05 mg/kg, once a day for 4-6 years and oral Estrogen (Ethinyl Estradiol, manufactured by Aburaihan, Iran) from the age of 11at the rate of 5 µg ( it will double every 3 to 6 months until to reach a dose of 30 µg) once a day and continues until the age of 16. Intervention 2: Second intervention group: In this group,  patients (N = 25) receive injection of growth hormone (Genotropin manufactured by Pfizer, US) from the beginning of short stature,  at the rate of 0.05 mg/kg, once a day for 4-6 years and oral Estrogen (Ethinyl Estradiol, manufactured by Aburaihan, Iran) from the age of 13 at the rate of 5 µg ( it will double every 3 to 6 months until to reach a dose of 30 µg) once a day and continues until the age of 16. Intervention 3: Control group: in this group patients (N = 25) do not receive growth hormone and estrogen until the age of 15 and are the same with both intervention groups in terms of age, sex, average parental height and stage of chronic kidney disease (There is no intervention in this 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>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>Davod Amirkashani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No193, zafar St, Modares Highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1919816766</zip>
        <telephone>+98 21 2304 6253</telephone>
        <email>amirkashani.d@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Davod Amirkashani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No193, zafar St, Modares Highway.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1919816766</zip>
        <telephone>+98 21 2304 6253</telephone>
        <email>amirkashani.m@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patient and parent consent to participate in the study.
Patients with chronic kidney disease (CKD).
Patients must be girls.
With short stature (height and growth velocity respectively below 3th and 25th  percentile for more than 1 year).
In all patients, beginning of dialysis around 3.5 to 5 years.
Growth hormone has been started in all patients from the age of 5.5 to 8 years, despite therapeutic indications.</inclusion_criteria>
      <agemin>3 years</agemin>
      <agemax>7 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Incidence puberty before the estrogen therapy
Kidney transplantation before the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N25</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Disorders resulting from impaired renal tubular function</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>ّFirst intervention group: In this group,  patients (N = 25) receive injection of growth hormone (Genotropin manufactured by Pfizer, US) from the beginning of short stature,  at the rate of 0.05 mg/kg, once a day for 4-6 years and oral Estrogen (Ethinyl Estradiol, manufactured by Aburaihan, Iran) from the age of 11at the rate of 5 µg ( it will double every 3 to 6 months until to reach a dose of 30 µg) once a day and continues until the age of 16.</i_keyword>
      <i_keyword>Second intervention group: In this group,  patients (N = 25) receive injection of growth hormone (Genotropin manufactured by Pfizer, US) from the beginning of short stature,  at the rate of 0.05 mg/kg, once a day for 4-6 years and oral Estrogen (Ethinyl Estradiol, manufactured by Aburaihan, Iran) from the age of 13 at the rate of 5 µg ( it will double every 3 to 6 months until to reach a dose of 30 µg) once a day and continues until the age of 16.</i_keyword>
      <i_keyword>Control group: in this group patients (N = 25) do not receive growth hormone and estrogen until the age of 15 and are the same with both intervention groups in terms of age, sex, average parental height and stage of chronic kidney disease (There is no intervention in this group).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Final height after 15 years old. Timepoint: Before the intervention and after the age of 15. Method of measurement: Height gauge.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Bone density. Timepoint: Before the intervention and after the age of 15. Method of measurement: Dexa bone densitometry.</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>2020-10-26</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Next to the Milad Tower, Shahid Hemmat Highway Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
