<?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>IRCT20191109045372N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-12-10</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Selenium in metabolic syndrome</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Selenium Supplementation on Glucose Homeostasis and Lipid Profile in Women with Metabolic Syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/43526</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: The subjects were categorized into selenium and placebo groups as two random block designs. In the selenium group, 200 mcg selenium capsule while in the placebo group, a placebo capsule which was identical to selenium in terms of color and appearance were given to the subjects for 8 weeks, Blinding description: In this study, patients and people who will do the tests will not know if they are taking selenium or placebo, and only the researcher and data analyzer will know how to blind.</study_design>
      <phase>3</phase>
      <hc_freetext>METABOLIC SYNDROME.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Thirty-five patients were included in the intervention group.Participants were delivered a 200 microgram selenium capsule made by 21st Century America Inc. purchased from Pourtab Tehran.Participants were given the capsule for 8 weeks. Each person consumes one selenium capsule daily. Intervention 2: Control group: Thirty-five subjects were included in the control group.In the control group, a placebo containing 200 μg dextrose was not significantly different in appearance and color from selenium. Subjects in the placebo group consumed one placebo capsule daily for 8 weeks.The placebo was manufactured by the Faculty of Pharmacy of Isfahan University of Medical Sciences.</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:
Information on major and minor consequences will be shared.

When:
One year after publishing the documentation

To whom:
Anyone working in this field can apply for documentation.

Conditions:
People can access the documentation via email.

Where to obtain:
People can access the documentation via email.

How to obtain:
People can access the desired documentation in a file if they email the person in charge.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zeinab Malekpour Shahraki</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezargarib Street</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>73461-81746</zip>
        <telephone>+98 31 3792 3151</telephone>
        <email>msz_nut@yahoo.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Hasan Entezari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezargarib Street</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>73461-81746</zip>
        <telephone>+98 31 3792 3151</telephone>
        <email>entezari@hlth.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Were no consumption of antioxidant supplements
NO underlying diseases including kidney diseases, hypothyroidism, digestive diseases, dyspepsia, etc.
Not being in menopause
Not having weight loss diet over the last six months
Not taking any drugs affecting the level of blood lipids
No pregnancy and breast-feeding</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>49 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>No willingness to continue the cooperation, pregnancy, not adhering to the study protocol, developing special diseases during the study were among the exclusion criteria. Note that patients taking insulin were also excluded.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E88.81</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Metabolic syndrome</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Thirty-five patients were included in the intervention group.Participants were delivered a 200 microgram selenium capsule made by 21st Century America Inc. purchased from Pourtab Tehran.Participants were given the capsule for 8 weeks. Each person consumes one selenium capsule daily.</i_keyword>
      <i_keyword>Control group: Thirty-five subjects were included in the control group.In the control group, a placebo containing 200 μg dextrose was not significantly different in appearance and color from selenium. Subjects in the placebo group consumed one placebo capsule daily for 8 weeks.The placebo was manufactured by the Faculty of Pharmacy of Isfahan University of Medical Sciences</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>FBS. Timepoint: The beginning of the study and the end of the study. Method of measurement: Biochemical.</prim_outcome>
      <prim_outcome>Insulin. Timepoint: The beginning of the study and the end of the study. Method of measurement: Eliza.</prim_outcome>
      <prim_outcome>HOMA-IR. Timepoint: The beginning of the study and the end of the study. Method of measurement: FORMULA.</prim_outcome>
      <prim_outcome>QUICKI. Timepoint: The beginning of the study and the end of the study. Method of measurement: FORMULA.</prim_outcome>
      <prim_outcome>TRIGLYCERIDE. Timepoint: The beginning of the study and the end of the study. Method of measurement: BIOCHEMICAL.</prim_outcome>
      <prim_outcome>Total cholestrol. Timepoint: The beginning of the study and the end of the study. Method of measurement: Biochemical.</prim_outcome>
      <prim_outcome>HDL cholestrol. Timepoint: The beginning of the study and the end of the study. Method of measurement: BIOCHEMICAL.</prim_outcome>
      <prim_outcome>LDL cholestrol. Timepoint: The beginning of the study and the end of the study. Method of measurement: Formula.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Body Mass Index. Timepoint: The beginning and the end of the study. Method of measurement: Weight (kg) / Height (m) to power 2.</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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-08-19</approval_date>
        <contact_name>EthicsCommittee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Hezargarib Street Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
