<?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>IRCT2016061228407N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-06-25</date_registration>
      <primary_sponsor>Zahedan University of Medical Sciences</primary_sponsor>
      <public_title>The effectiveness of CoQ10 antioxidant supplements in the prevention of the harmful effects of occupational exposure to heavy metals and organic solvents</public_title>
      <acronym></acronym>
      <scientific_title>The study of the protective effect efficiency of antioxidant CoQ10 supplement on blood levels of total antioxidant capacity, antioxidant enzymes activity and malondialdehyde of workers in ceramic and printing industries</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-07-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/23057</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Toxic effect of organic solvents. Condition 2: Toxic effect of metals. Condition 3: Toxic effect of metals.</hc_freetext>
      <i_freetext>Intervention 1: The intervention group consists of 20 workers exposed to organic solvents in the printing industry and 20 workers exposed to heavy metals in the tile industry who received  capsules 60 mg oral COQ10 twice daily for 60 days. Intervention 2: The control group consists of 20 workers exposed to organic solvents in the printing industry and 20 workers exposed to heavy metals in the tile industry who received capsules 60 mg oral placebo twice daily for 60 days.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Hormozi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Doctor Hesabi Square</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9816743175</zip>
        <telephone>+98 54 3348 8718</telephone>
        <email>hormozym@yahoo.comdr.hormozi@zaums.ac.ir</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ramazan Mirzaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Doctor Hesabi Square</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 54 3329 5827</telephone>
        <email>mirzaei@zaums.ac.ir   rammir277@gmail.com</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Having at least one year of experience in the production line; giving consent to participate in the study&#13;
&#13;
Exclusion criteria: History of chronic diseases of the thyroid, liver, kidney, diabetes, cardiovascular disease, cancer and high blood pressure; use of antioxidant supplements by person; Having Positive test G6PDH</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>T52.2</hc_code>
      <hc_code>T56.0</hc_code>
      <hc_code>T56.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Homologues of benzene</hc_keyword>
      <hc_keyword>Lead and its compounds</hc_keyword>
      <hc_keyword>Cadmium and its compounds</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Placebo</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The intervention group consists of 20 workers exposed to organic solvents in the printing industry and 20 workers exposed to heavy metals in the tile industry who received  capsules 60 mg oral COQ10 twice daily for 60 days.</i_keyword>
      <i_keyword>The control group consists of 20 workers exposed to organic solvents in the printing industry and 20 workers exposed to heavy metals in the tile industry who received capsules 60 mg oral placebo twice daily for 60 days.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Malondialdehyde. Timepoint: Before the intervention, two months after the intervention. Method of measurement: Measurement of blood plasma levels of malondialdehyde in terms of nmol per ml.</prim_outcome>
      <prim_outcome>Total antioxidant capacity. Timepoint: total antioxidant capacity. Method of measurement: Measurement of antioxidant capacity in blood plasma in terms of micromoles per liter.</prim_outcome>
      <prim_outcome>Superoxide dismutase activity. Timepoint: Before the intervention, two months after the intervention. Method of measurement: Measurment of  the level of erythrocyte superoxide dismutase activity in terms of unit per gram of hemoglobin.</prim_outcome>
      <prim_outcome>Glutathione peroxidase activity. Timepoint: Before the intervention, two months after the intervention. Method of measurement: Measurment of the level of erythrocyte glutathione peroxidase activity in terms of unit per gram of hemoglobin.</prim_outcome>
      <prim_outcome>Catalase activity. Timepoint: Before the intervention, two months after the intervention. Method of measurement: Measurment of the level of erythrocyte catalase activity in terms of unit per gram of hemoglobin.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Headache. Timepoint: Before the intervention and at the end of intervention. Method of measurement: According to Commenting person.</sec_outcome>
      <sec_outcome>Nausea. Timepoint: Before the intervention and at the end of intervention. Method of measurement: According to Commenting person.</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>2016-06-05</approval_date>
        <contact_name>Zahedan University of Medical Sciences</contact_name>
        <contact_address>Pardis of the University of Medical Sciences, Doctor Hsabi Squre Zahedan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
