<?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>IRCT138806301197N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2010-03-20</date_registration>
      <primary_sponsor>Nutritional Research Center Tabriz University Of Medical Science</primary_sponsor>
      <public_title>Effects of alpha lipoic acid supplementation on serum level of visfatin, markers of oxidative stress, inflammation and insulin resistance in patients with chronic renal failure undergoing hemodialysis.</public_title>
      <acronym></acronym>
      <scientific_title>Effects of alpha lipoic acid supplementation on serum level of visfatin, markers of oxidative stress, inflammation and insulin resistance in patients with chronic renal failure undergoing hemodialysis.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2010-01-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/401</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>chronic renal failure.</hc_freetext>
      <i_freetext>Intervention 1: Daily consumption of alpha lipoic acid capsule (600 mg) for 8 weeks. Intervention 2: daily consumption of placebo for 8 weeks.</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>Reza mahdavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tabriz University of Medical Sciences</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 41 1335 7580</telephone>
        <email>mahdavir@tbzmed.ac.ir     t.khabbazi@gmail.com</email>
        <affiliation>Tabriz University Of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Tannaz Khabbazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tabriz University Of Medical Sciences</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 41 1335 7580</telephone>
        <email>t.khabbazi@gmail.com</email>
        <affiliation>Tabriz University Of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: obtaining informed consent, being on hemodialysis for more than 6 months, receiving 3 times hemodialysis each week &#13;
Exclusion criteria: hepatitis and other infections less than 20 years, receiving any NSAID and SAID, alpha lipoic acid supplement, vitamin C, vitamin E, valporic acid in the month prior to the study,  presence of gastrointestinal disorders, being candidate for kidney transplantation,  pregnancy or lactation, smoking, possibility of any side effect for consumption of the supplement</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N18.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>End-stage renal disease</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code></i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Daily consumption of alpha lipoic acid capsule (600 mg) for 8 weeks</i_keyword>
      <i_keyword>daily consumption of placebo for 8 weeks</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Visfatin. Timepoint: baseline and after 8 weeks. Method of measurement: ELIZA.</prim_outcome>
      <prim_outcome>TAC. Timepoint: baseline and after 8 weeks. Method of measurement: calorimetric method.</prim_outcome>
      <prim_outcome>MDA. Timepoint: baseline and after 8 weeks. Method of measurement: flurimetric method.</prim_outcome>
      <prim_outcome>HsCRP. Timepoint: baseline and after 8 weeks. Method of measurement: immunoturbidometric method.</prim_outcome>
      <prim_outcome>Fasting insulin. Timepoint: baseline and after 8 weeks. Method of measurement: ELIZA.</prim_outcome>
      <prim_outcome>Fasting Glu. Timepoint: baseline and after 8 weeks. Method of measurement: calorimetric method.</prim_outcome>
      <prim_outcome>HOMA-IR. Timepoint: baseline and after 8 weeks. Method of measurement: formula.</prim_outcome>
      <prim_outcome>Tchol. Timepoint: baseline and after 8 weeks. Method of measurement: calorimetric method.</prim_outcome>
      <prim_outcome>Serum TG. Timepoint: baseline and after 8 weeks. Method of measurement: calorimetric method.</prim_outcome>
      <prim_outcome>Serum HDL-c. Timepoint: baseline and after 8 weeks. Method of measurement: calorimetric method.</prim_outcome>
      <prim_outcome>Serum LDL. Timepoint: baseline and after 8 weeks. Method of measurement: Friedelwald formula.</prim_outcome>
      <prim_outcome>Body Mass Index (BMI). Timepoint: baseline and after 8 weeks. Method of measurement: calculation.</prim_outcome>
      <prim_outcome>Total Daily Calorie. Timepoint: baseline and after 8 weeks. Method of measurement: 24h recalls.</prim_outcome>
      <prim_outcome>Daily protein. Timepoint: baseline and after 8 weeks. Method of measurement: 24h recalls.</prim_outcome>
      <prim_outcome>Daily Fat. Timepoint: baseline and after 8 weeks. Method of measurement: 24h recall.</prim_outcome>
      <prim_outcome>Daily charbohydrate. Timepoint: baseline and after 8 weeks. Method of measurement: 24h recall.</prim_outcome>
      <prim_outcome>Update 19 Feb 2011: serum albomin. Timepoint: Update 19 Feb 2011: baseline and after 8 weeks. Method of measurement: Update 19 Feb 2011: Bromocresol Green method.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Health benefits for patients. Timepoint: baseline and weekly monitoring. Method of measurement: observation and evaluation of biochemical parameters.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Vice Chancellor for Research, Tabriz University Of Medical Science</sponsor_name>
      <sponsor_name>Drug Applied Research Center Tabriz University Of Medical Sciences</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Nutritional Research Center Tabriz University Of Medical Science</source_name>
      <source_name>Vice Chancellor for Research, Tabriz University Of Medical Science</source_name>
      <source_name>Drug Applied Research Center Tabriz University Of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2009-10-05</approval_date>
        <contact_name>The Research Ethics Committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Tabriz University of Medical Sciences Tabriz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
