<?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>IRCT2015060622562N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-08-02</date_registration>
      <primary_sponsor>Vice chancellor for research, Kashan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of selenium on nephropathy complications of diabetic patients</public_title>
      <acronym></acronym>
      <scientific_title>The effects of selenium supplementation on advanced glycation end products, biomarkers of inflammatory and oxidative stress in diabetic nephropathy patients in comparison with placebo: a randomized double-blinded controlled clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-07-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/19434</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: At study baseline and after stratification for pre-intervention BMI and age, subjects will be randomly divided into two groups to take either selenium supplements (n = 30) or placebo (n = 30). Randomization will be done by the use of computer-generated random numbers, Blinding description: Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Shahid Beheshti Clinic, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules.</study_design>
      <phase>2</phase>
      <hc_freetext>diabetic nephropathy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention: received one capsule of 200 μg selenium, daily for three months. Intervention 2: control: received one capsule of placebo daily for three months.</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 Undecided - It is not yet known if there will be a plan to make this available</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Fereshteh Bahmani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Medical Faculty,Kashan University of Medical Sciences,Ravand road</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81151-87159</zip>
        <telephone>+98 31 5554 0021</telephone>
        <email>bahmani@kaums.ac.ir</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Fereshteh Bahmani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Medical Faculty, Kashan University of Medical Sciences, Ravand road</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81151-87159</zip>
        <telephone>+98 31 5554 0021</telephone>
        <email>bahmani@kaums.ac.ir</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diabetic nephropathy  with a proteinuria level of &gt;0.3 g/24 hours
With or without circulating levels of serum creatinine</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>85 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The consumption of selenium supplements within 3 months before beginning of the study
Patients with uncontrolled diabetes
Pregnant women
Liver diseases
Inflammatory diseases
Bacteriuria
Haematuria
Urinary tract infection
History of hospital admission within 3 months</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E11.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>non-insulin-dependent diabetes mellitus with renal complications</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention: received one capsule of 200 μg selenium, daily for three months</i_keyword>
      <i_keyword>control: received one capsule of placebo daily for three months</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Serum insulin. Timepoint: Before and three months after intervention. Method of measurement: In serum sample will assessed by ELISA kit. mU/ml.</prim_outcome>
      <prim_outcome>Inflammatory factor hs-CRP. Timepoint: Before and three months after intervention. Method of measurement: In serum sample will assessed by ELISA kit. ng/ml.</prim_outcome>
      <prim_outcome>Insulin resistance. Timepoint: Before and three months after intervention. Method of measurement: Calculation using HOMA formula.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Matrix metalloproteinases 2 (MMP2). Timepoint: Before and three months after intervention. Method of measurement: In serum sample will assessed by ELISA kit. ng/ml.</sec_outcome>
      <sec_outcome>Protein carbonyl. Timepoint: Before and three months after intervention. Method of measurement: In serum sample will assessed by cholorimetric method.</sec_outcome>
      <sec_outcome>Tumor growth factor-beta (TGF-b). Timepoint: Before and three months after intervention. Method of measurement: In serum sample will assessed.by an enzyme-linking immunosorbent.</sec_outcome>
      <sec_outcome>Gluthatione peroxidase (GPx). Timepoint: Before and three months after intervention. Method of measurement: In serum sample will assessed.by an enzyme-linking immunosorbent.</sec_outcome>
      <sec_outcome>Malondialdehyde (MAD). Timepoint: Before and three months after intervention. Method of measurement: In serum sample will assessed.by spectrophotometric method.µmol/L.</sec_outcome>
      <sec_outcome>Advanced glycation end products (AGEs). Timepoint: Before and three months after intervention. Method of measurement: In serum sample will assessed by fluorescence method.</sec_outcome>
      <sec_outcome>Total Gluthatione. Timepoint: Before and three months after intervention. Method of measurement: In serum sample will assessed.by spectrophotometric method.µmol.</sec_outcome>
      <sec_outcome>Plasma total antioxidant. Timepoint: Before and three months after intervention. Method of measurement: In serum sample will assessed by cholorimetric 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>Vice chancellor for research, Kashan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-05-24</approval_date>
        <contact_name>Ethics Committee of Kashan university of medical sciences and health services</contact_name>
        <contact_address>kashan university of medical sciences and health services, Ravand road Kashan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
