<?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>IRCT20190722044303N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-12-25</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>The Effects of Coenzyme Q10 Supplementation in Pediatrics with Chronic Kideny Disease : A Randomized, Paralleled, Double blind, Controlled clinical trial</public_title>
      <acronym>co Q10</acronym>
      <scientific_title>The Effects of Coenzyme Q10 Supplementation in Pediatrics with Chronic Kideny Disease stage 2 - 4 : A Randomized, Paralleled, Double blind, Controlled clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-08-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/41020</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly divided into control and intervention groups using Blocked Randomization method. In this method, computer generated block sizes of 4 with equal probability will be used to enter eligible patients into one of the groups, intervention (Group B) and control (Group A). Initially one of the blocks will be randomly selected and the blocks will be repeatedly used to enter all eligible patients into one of the two groups.
Patients in the intervention group (Group B) will be treated with the usual treatment regimen, plus Co Q10, 3 mg / kg and up to 100 mg daily for 3 months. In the control group, patients will receive only the usual treatment regimen, Blinding description: In this study, the physician and participants are blind. After the diagnosis of the disease, the physician will give the patients the envelopes on which A or B are written. The patient will deliver the envelope to the investigator, and after checking the inclusion and exclusion criteria of the study, the patient will be assigned to either the control (A) or intervention (B) groups based on the envelopes. Only the investigator knows which group is intervention and which group is control.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic Kidney Disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: After entering the trial, patients will be prescribed to take co enzyme Q10 supplement from Nutri Century Corporation 3 mg per kg up to 100 mg daily adjuvant to their routine medication. Intervention 2: Control group: After entering the trial, patients will only receive their routine medications without Q10. Blood and urine tests will be taken at time 0 and three months after taking Q10.</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Pedram Shayesteh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.D3, Sarv 7 Building, Koohestan towers, Koohestan street, Ketab squire, Saadat abad, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>198118395</zip>
        <telephone>+98 21 2214 0806</telephone>
        <email>peddy.sh@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Parastoo Mirzabeygi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ali Asghar children Hospital, Zafar street, Modarres Highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1919816766</zip>
        <telephone>+98 21 2222 2041</telephone>
        <email>mirzabeygi.p@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 2 to 18 years old
Diagnosed with Chronic Kidney Disease stage 2 - 4 according to estimated Glomerular Filtration Rate (eGFR) findings</inclusion_criteria>
      <agemin>2 years</agemin>
      <agemax>18 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Liver disease
Chronic pulmonary disease
Autoimmune disease
Gastrointestinal dysfunction with the need for Parenteral nutrition
Kidney transplantation in last 6 months
Taking Antioxidants such as Vit E , L-Carnitine, or Omega 3 supplements in past 3 months
Taking corticosteroids and/or immunosuppressive medication</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N18</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic kidney disease (CKD)</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: After entering the trial, patients will be prescribed to take co enzyme Q10 supplement from Nutri Century Corporation 3 mg per kg up to 100 mg daily adjuvant to their routine medication.</i_keyword>
      <i_keyword>Control group: After entering the trial, patients will only receive their routine medications without Q10. Blood and urine tests will be taken at time 0 and three months after taking Q10.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Blood Urea Nitrogen level. Timepoint: Before starting an intervention and three months after taking co enzyme Q10 supplement. Method of measurement: Blood test, Photometric kit.</prim_outcome>
      <prim_outcome>Creatinine level. Timepoint: Before starting an intervention and three months after taking co enzyme Q10 supplement. Method of measurement: Blood test, photometric kit.</prim_outcome>
      <prim_outcome>EGFR. Timepoint: Before starting an intervention and three months after taking co enzyme Q10 supplement. Method of measurement: Calculation based on blood Creatinine and patient's height.</prim_outcome>
      <prim_outcome>Proteinuria. Timepoint: Before starting an intervention and three months after taking co enzyme Q10 supplement. Method of measurement: Urine test, Dipstick.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>C-Reactive Protein (CRP) level. Timepoint: Before starting the intervention and 3 months after taking co enzyme Q10 supplement. Method of measurement: Blood test, Agglutination method.</sec_outcome>
      <sec_outcome>Erythrocyte Sedimentation Rate (ESR) level. Timepoint: Before starting the intervention and 3 months after taking co enzyme Q10 supplement. Method of measurement: Blood test, Photometric kit.</sec_outcome>
      <sec_outcome>Fasting blood Glucose level. Timepoint: Before starting the intervention and 3 months after taking co enzyme Q10 supplement. Method of measurement: Blood test, Photometric test.</sec_outcome>
      <sec_outcome>Alanine Aminotransferase (ALT) level. Timepoint: Before starting the intervention and 3 months after taking co enzyme Q10 supplement. Method of measurement: Blood test, photometric kit.</sec_outcome>
      <sec_outcome>Aspartate Aminotransferase (AST) level. Timepoint: Before starting the intervention and 3 months after taking co enzyme Q10 supplement. Method of measurement: Blood test, photometric kit.</sec_outcome>
      <sec_outcome>Blood Triglyceride level. Timepoint: Before starting the intervention and 3 months after taking co enzyme Q10 supplement. Method of measurement: Blood test, photometric kit.</sec_outcome>
      <sec_outcome>Low Density Lipoprotein (LDL) level. Timepoint: Before starting the intervention and 3 months after taking co enzyme Q10 supplement. Method of measurement: Blood test, photometric kit.</sec_outcome>
      <sec_outcome>High Density Lipoprotein (HDL) level. Timepoint: Before starting the intervention and 3 months after taking co enzyme Q10 supplement. Method of measurement: Blood test, photometric kit.</sec_outcome>
      <sec_outcome>Total Cholesterol level. Timepoint: Before starting the intervention and 3 months after taking co enzyme Q10 supplement. Method of measurement: Blood test, photometric kit.</sec_outcome>
      <sec_outcome>Urine protein level. Timepoint: Before starting the intervention and 3 months after taking co enzyme Q10 supplement. Method of measurement: Urine test, Dipstick method.</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>2019-07-16</approval_date>
        <contact_name>Ethics committee of Iran university of medical sciences</contact_name>
        <contact_address>Iran University of Medical Sciences, 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>
