<?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>IRCT2013030312689N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-08-02</date_registration>
      <primary_sponsor>Vice chancellor for research, Ahvaz Jondishapur University Of Medical Sciences</primary_sponsor>
      <public_title>effect of soymilk intake on inflammatory markers and oxidative stress</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effects of soy milk and cow's milk intake on the levels of inflammatory markers, proinflammatory cytokines and oxidative stress in patients with rheumatoid arthritis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-04-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/12712</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Supportive.</study_design>
      <phase>2</phase>
      <hc_freetext>Rheumatoid arthritis.</hc_freetext>
      <i_freetext>Intervention 1: intervention group: daily consumption of 200 ml calcium-fortified soy milk (1% fat) for 4 weeks.&#13;
produced by Soya Sun Company, in Iran. Intervention 2: control group: daily consumption of 200 ml cow's milk (1.5% fat) for 4 weeks.&#13;
produced by Mihan-Dairy Company, in Iran.</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>Razieh Choghakhori</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ahvaz Jondishapur University of Medical Sciences, Golestan Ave. Ahvaz</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 61 1373 8254</telephone>
        <email>choghakhori.r@ajums.ac.ir</email>
        <affiliation>School of Paramedicine, Ahvaz Jondishapur University Of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Majid Mohammadshahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ahvaz Jondishapur University Of Medical Sciences, Golestan Ave. Ahvaz</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 61 1373 8254</telephone>
        <email>shahi334@gmail.com</email>
        <affiliation>School of Paramedicine, Ahvaz Jondishapur University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: 18-65 years old patient who have Rheumatoid Arthritis according to revised American Rheumatism Association criteria and Rheumatologist diagnosis. The type and dose of drug medication remain constant since 1 month prior and during of the study. &#13;
Exclusion criteria: Patients who have chronic disease such as diabetes, cardiovascular, hepatic, kidney, gastrointestinal diseases, and severe infection. Smoking, alcohol consumption, use of dietary supplements and having allergy to soy products or cow’s milk.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M05</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Seropositive rheumatoid arthritis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>intervention group: daily consumption of 200 ml calcium-fortified soy milk (1% fat) for 4 weeks.&#13;
produced by Soya Sun Company, in Iran.</i_keyword>
      <i_keyword>control group: daily consumption of 200 ml cow's milk (1.5% fat) for 4 weeks.&#13;
produced by Mihan-Dairy Company, in Iran.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>TNF-α. Timepoint: at baseline and end of each intervention. Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>IL-1. Timepoint: at baseline and end of each intervention. Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>Hs-CRP. Timepoint: at baseline and end of each intervention. Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>IL-6. Timepoint: at baseline and end of each intervention. Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>Adiponectin. Timepoint: at baseline and end of each intervention. Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>Leptin. Timepoint: at baseline and end of each intervention. Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>RF. Timepoint: at baseline and end of each intervention. Method of measurement: Nephlometry.</prim_outcome>
      <prim_outcome>MDA. Timepoint: at baseline and end of each intervention. Method of measurement: Spectrophotometric.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Blood Pressure. Timepoint: at baseline and end of each intervention. Method of measurement: Blood Pressure Monitor.</sec_outcome>
      <sec_outcome>Weight. Timepoint: at baseline and end of each intervention. Method of measurement: digital scale.</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 Jondishapur University Of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-03-03</approval_date>
        <contact_name>Ethics Committee of Ahvaz Jondishapur University Of Medical Sciences</contact_name>
        <contact_address>Jondishapur University Of Medical Sciences, Golestan Ave. Ahvaz Ahvaz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
