<?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>IRCT20180311039043N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-12-31</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Effects of flaxseed consumption and flax oil supplement on serum levels of inflammatory markers, adipokines, and components of metabolic syndrome and severity of disease in patients with ulcerative colitis</public_title>
      <acronym></acronym>
      <scientific_title>Effects of flaxseed consumption and flax oil supplement on serum levels of inflammatory markers, adipokines, and components of metabolic syndrome and severity of disease in patients with ulcerative colitis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-08-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/32673</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The order of entering people into groups is simple. According to the order of entry of patients into the study, they are assigned to 3 groups: the first patient in the first group, the second patient in the second group, the third patient in the third group, the fourth patient in the first group, and , Blinding description: The data analyst and clinical physician are not aware of the distribution of patients in the three study groups.</study_design>
      <phase>3</phase>
      <hc_freetext>کولیت اولسراتیو.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  take 7 gram flaxseed oil (group A). Intervention 2: Intervention group: 30 gram ground flaxseed (group B). Intervention 3: Control group: Comparison group- without receiving any supplements.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nava Morshedzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.2 Shahid Beheshti University of Medical Sciences, Arabi Ave, Daneshjoo Blvd, Velenjak</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>19839-63113</zip>
        <telephone>+98 21 2243 9770</telephone>
        <email>n.morshedzadeh@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nava Morshedzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.2 Shahid Beheshti University of Medical Sciences, Arabi Ave, Daneshjoo Blvd, Velenjak</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>19839-63113</zip>
        <telephone>+98 21 2243 9770</telephone>
        <email>n.morshedzadeh@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age: 18 -55 years
The body mass index (BMI) 20 and above
Ulcerative colitis, confirmed by histopathology
Mild to moderate ulcerative colitis.
willingness to cooperate in this project
Failure to change the type and dose of medication during the last 3 months.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K51</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Ulcerative colitis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:  take 7 gram flaxseed oil (group A)</i_keyword>
      <i_keyword>Intervention group: 30 gram ground flaxseed (group B)</i_keyword>
      <i_keyword>Control group: Comparison group- without receiving any supplements</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Severity of disease. Timepoint: 3 months. Method of measurement: Mayo Score / Disease Activity Index (DAI) questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Plasma glucose. Timepoint: 3 months. Method of measurement: laboratory kit.</sec_outcome>
      <sec_outcome>Triglyceride. Timepoint: 3 months. Method of measurement: laboratory kit.</sec_outcome>
      <sec_outcome>TNFα. Timepoint: 3 months. Method of measurement: ELISA.</sec_outcome>
      <sec_outcome>IFN-γ. Timepoint: 3 months. Method of measurement: ELISA.</sec_outcome>
      <sec_outcome>IL-6. Timepoint: 3 months. Method of measurement: ELISA.</sec_outcome>
      <sec_outcome>IL-1 β. Timepoint: 3 months. Method of measurement: ELISA.</sec_outcome>
      <sec_outcome>TGF-β. Timepoint: 3 months. Method of measurement: ELISA.</sec_outcome>
      <sec_outcome>Visfatin. Timepoint: 3 months. Method of measurement: ELISA.</sec_outcome>
      <sec_outcome>Resistin. Timepoint: 3 months. Method of measurement: ELISA.</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-04-21</approval_date>
        <contact_name>Ethics committee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>No.2 Shahid Beheshti University of Medical Sciences, Arabi Ave, Daneshjoo Blvd, Velenjak Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
