<?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>IRCT2015081623645N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-12-13</date_registration>
      <primary_sponsor>Vice chancellor for research, Ahvaz Jundishapour University of Medical Sciences</primary_sponsor>
      <public_title>Effect of astaxanthin intake in patients affected by type 2 diabetes mellitus</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Astaxanthin intake  on  expression of miR-146a and miR-126 in plasma, oxidative stress and inflammation markers and glycemic profile, compared with placebo in  patients with type 2 diabetes mellitus</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-10-07</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>48</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/20153</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>0 (exploratory trials)</phase>
      <hc_freetext>Diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Using of food supplement contain 8 mg of Astaxanthin daily orally for 8-weeks Made in USA. Intervention 2: Use of a placebo pill containing starch and manufacture by  Faculty of Pharmacy of Ahvaz Jundishapur University of Medical Sciences 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>Nafiseh Shokri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dept  of Nutrition, School of Paramedical, Ahvaz Jundishapur University of Medical Science,Golestan Ave,  Ahvaz,Khouzestan</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 61 3373 8330</telephone>
        <email>nafiseh.shokri@yahoo.com , shokri.n@ajums.ac.ir</email>
        <affiliation>Ahvaz Jundishapour University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Majid Mohammad Shahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dept  of Nutrition, School of Paramedical, Ahvaz Jundishapur University of Medical Science,Golestan Ave,  Ahvaz,Khouzestan</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 61 3373 8330</telephone>
        <email>shahi334@gmail.com</email>
        <affiliation>Ahvaz Jundishapur University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Willingness to participate in the study, age  range between 30-60 years old, Body Mass Index range between 19 and 35 kg per m2, HbA1C more than seven, not to be affected by renal, liver, lung and  autoimmune disease, normal thyroid status, patients who have received standard oral treatments for at least six months.&#13;
 Exclusion criteria:Failure to follow the study</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E11,E12</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Non-insulin-dependent diabetes mellitus, Malnutrition-related diabetes mellitus</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Using of food supplement contain 8 mg of Astaxanthin daily orally for 8-weeks Made in USA</i_keyword>
      <i_keyword>Use of a placebo pill containing starch and manufacture by  Faculty of Pharmacy of Ahvaz Jundishapur University of Medical Sciences for 8-weeks</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>FBS. Timepoint: at first and two months after intervention. Method of measurement: glucose enzymatic kit.</prim_outcome>
      <prim_outcome>Fructosamine. Timepoint: at first and two months after intervention. Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>HDL. Timepoint: at first and two months after intervention. Method of measurement: spectrophotometer.</prim_outcome>
      <prim_outcome>LDL. Timepoint: at first and two months after intervention. Method of measurement: spectrophotometer.</prim_outcome>
      <prim_outcome>TG. Timepoint: at first and two months after intervention. Method of measurement: spectrophotometer.</prim_outcome>
      <prim_outcome>IL6. Timepoint: at first and two months after intervention. Method of measurement: Elisa kit.</prim_outcome>
      <prim_outcome>Adiponectin. Timepoint: at first and 2 months after intervention. Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>MDA. Timepoint: at first and two months after intervention. Method of measurement: TBARS.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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, Ahvaz Jundishapour University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-07-25</approval_date>
        <contact_name>Ethics Committee of Ahvaz Jundishapur University of Medical Sciences</contact_name>
        <contact_address>Khuozestan, Ahvaz, Ahvaz Jundishapur University of Medical Sciences, Ethics Committee Ahvaz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
