<?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>IRCT20170214032571N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-01-13</date_registration>
      <primary_sponsor>Urmia University of Medical Sciences</primary_sponsor>
      <public_title>The effect of omega-3 and zinc in the treatment of diabetes</public_title>
      <acronym></acronym>
      <scientific_title>The effect of supplemental omega-3 and zinc supplementation on inflammation, lipid profiles and antioxidant capacity in type 2 diabetic patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-09-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/25341</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Factorial, Purpose: Supportive, Randomization description: Patients were divided into 4 equal groups of 20 (A total of 80),A , B, C and D, 
 by using simple randomization method.The study groups included omega-3 (A), zinc (B), omega-3 and zinc (C), and placebo-control group (D).Randomization was assigned to a random assignment list by a research team member, Blinding description: Randomization was assigned to a random assignment list by a research team member as the only non-blind person. Other members of the research team (including team leader and study coordinator) as well as all participants participated in the random allocation of blind groups and remained blind until the end of the study.In fact, in this study, patients were blinded to  use of placebo or supplementation. Also, all of the study subjects were blind except for one group.</study_design>
      <phase>3</phase>
      <hc_freetext>Type 2 diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Group A = Intervention group with omega-3 doses of 1000 mg with lunch. Intervention 2: Group C = Omega 3 group with zinc. Intervention 3: Group A = Intervention group with zinc   dose of 30 mg in the evening meal. Intervention 4: Group D = Receptor of Starch Placebo.</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 Unwillingness to publish individual data</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Majid Monafi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Urmia University of Medical Sciences</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5714783734</zip>
        <telephone>+98 44433659218</telephone>
        <email>MAJIDMANAFI@YAHOO.COM</email>
        <affiliation>Urmia University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Majid Monafi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Urmia University of Medical Sciences</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5714783734</zip>
        <telephone>+98 44433659218</telephone>
        <email>MAJIDMANAFI@YAHOO.COM</email>
        <affiliation>Urmia University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>tendency to Cooperation
Type 2 diabetic patients ; taking metformin or glibenclamide glucose or similar drugs by patients
Age range 18 to 65 years
use of lipid lowering statin drugs and a blood pressure lowering drugs</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Unwillingness to participate in the study
Insulin injection
Do not consume 80% of supplements per course
People with pancreatic cancer and patients receiving steroidal anti-inflammatory drugs (due to secondary hyperglycemia)
severe physical activity
Use of omega-3 and zinc supplementation in the last three months
developing any underlying coronary artery disease and cancer
taking antidepressants (because of interactions with zinc supplementation)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E10, E11, </hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diabetes mellitus</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Group A = Intervention group with omega-3 doses of 1000 mg with lunch</i_keyword>
      <i_keyword>Group C = Omega 3 group with zinc</i_keyword>
      <i_keyword>Group A = Intervention group with zinc   dose of 30 mg in the evening meal</i_keyword>
      <i_keyword>Group D = Receptor of Starch Placebo</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Total cholesterol. Timepoint: Before intervention and two months after intervention. Method of measurement: Enzymatic method, mg / dl.</prim_outcome>
      <prim_outcome>TAC. Timepoint: Before intervention and two months after intervention. Method of measurement: Colorimetric.</prim_outcome>
      <prim_outcome>Hs-crp. Timepoint: Before intervention and two months after intervention. Method of measurement: Eliza-mg/dl.</prim_outcome>
      <prim_outcome>HDL. Timepoint: Before intervention and two months after intervention. Method of measurement: Enzymatic method, mg / dl.</prim_outcome>
      <prim_outcome>Tri glyceride ‏‫. Timepoint: Before intervention and two months after intervention. Method of measurement: Enzymatic method, mg / dl.</prim_outcome>
      <prim_outcome>LDL. Timepoint: Before intervention and two months after intervention. Method of measurement: Enzymatic method, mg / dl.</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>Urmia University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-09-09</approval_date>
        <contact_name>ethics Committee of Urmia University of Medical Sciences</contact_name>
        <contact_address>Nutrition Department, Faculty of Medicine, College of Medicine, Urmia University of Medical Science, 11th km of Nazloo Road, Urmia Urmia West Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
