<?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>IRCT20100606004105N30</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-08-02</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Effect of zinc in treatment of Behcet syndrome</public_title>
      <acronym></acronym>
      <scientific_title>The effects of zinc gluconate supplementation on several genes expression, the serum level of inflammatory factors, quality of life, and disease activity in patients with Behcet syndrome: double-blind randomized controlled clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-08-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>52</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49785</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: After reaching the inclusion criteria, individuals will be randomly divided into two groups of intervention and placebo by blocking method. Blocking will be performed based on gender and age and whereby the two groups will be matched in terms of age and gender. The four blocks will be created by STATA statistical software using ralloc command, which will be identified by the letters A, B, C, D. The assigned group is not known before the individual assignment, Blinding description: All tablets (zinc and placebo) in the same shape and color are placed and labeled in the containers by a third person, and two codes are given to individuals, and the codes will be unknown to the researcher until the end of the study.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Behcet Syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: one zinc gluconate tablet daily (120 mg each tablet containing 30 mg elemental zinc) with a meal for 12 weeks. Intervention 2: Control group: Placebo (microcrystalline cellulose): 1 tablet (120 mg each) with a meal for 12 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>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 There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Beitullah Alipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nutrition and Food Sciences, Attar-e Nishaboori ST</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5183874384</zip>
        <telephone>+98 41 3441 5285</telephone>
        <email>alipourb@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Beit Allah Alipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nutrition and Food Sciences, Attar-e Nishaboori ST</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5183874384</zip>
        <telephone>+98 41 3335 7584</telephone>
        <email>alipourb@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age range 18 to 50 years (premenopausal woman)
Diagnosis of Behcet's disease by a rheumatologist according to IBCD (The International Criteria for Behcet’s Disease) which vascular, eyes, and joints complications indicate the severity of the disease
Patients who want to participate in the study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnancy and lactation
History of diabetes and other chronic diseases
History of other autoimmune diseases
Taking nutritional supplements and antioxidants and alpha lipoic acid during the month before the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M35.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Behcet's disease</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: one zinc gluconate tablet daily (120 mg each tablet containing 30 mg elemental zinc) with a meal for 12 weeks</i_keyword>
      <i_keyword>Control group: Placebo (microcrystalline cellulose): 1 tablet (120 mg each) with a meal for 12 weeks</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Toll-like Receptor-2 gene expression. Timepoint: Before and the end of the intervention (twelfth week). Method of measurement: Real time PCR.</prim_outcome>
      <prim_outcome>Toll-like Receptor-4 gene expression. Timepoint: Before and the end of the intervention (twelfth week). Method of measurement: Real time PCR.</prim_outcome>
      <prim_outcome>Toll-like Receptor-2 protein expression. Timepoint: Before and the end of the intervention (twelfth week). Method of measurement: Flow cytometry.</prim_outcome>
      <prim_outcome>Toll-like Receptor-4 protein expression. Timepoint: Before and the end of the intervention (twelfth week). Method of measurement: Flow cytometry.</prim_outcome>
      <prim_outcome>Serum level of tumor necrosis factor-alpha. Timepoint: Before and the end of the intervention (twelfth week). Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>Serum level of zinc. Timepoint: Before and the end of the intervention (twelfth week). Method of measurement: Atomic absorption spectroscopy.</prim_outcome>
      <prim_outcome>NLRP3 gene expression. Timepoint: Before and the end of the intervention (twelfth week). Method of measurement: Real time PCR.</prim_outcome>
      <prim_outcome>Caspase-1 gene expression. Timepoint: Before and the end of the intervention (twelfth week). Method of measurement: Real time PCR.</prim_outcome>
      <prim_outcome>Serum level of interleukin-1 beta. Timepoint: Before and the end of the intervention (twelfth week). Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>Serum level of malondialdehyde. Timepoint: Before and the end of the intervention (twelfth week). Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>Serum level of C-reactive protein. Timepoint: Before and the end of the intervention (twelfth week). Method of measurement: ELISA.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality of life. Timepoint: Before, middle (sixth week) and end of intervention (twelfth week). Method of measurement: Behçet’s disease quality-of-life (BD-QoL) questionnaire.</sec_outcome>
      <sec_outcome>Disease activity. Timepoint: Before, middle (sixth week) and end of intervention (twelfth week). Method of measurement: Behcets Disease Activity Form.</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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-06-29</approval_date>
        <contact_name>Ethics committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Tabriz University of Medical Sciences, Golgasht street Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-04-12</approval_date>
        <contact_name>Ethics committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Tabriz University of Medical Sciences, Golgasht street Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
