<?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>IRCT20100123003140N21</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-05-05</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Effect of omega 3 in Parkinson disease.</public_title>
      <acronym></acronym>
      <scientific_title>Effect of omega 3 fatty acids  supplement on inflamatory factor ( IL-1β, IL-6, TNF-α, IL-10) and lipid profile of prakinson disease.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-04-18</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>44</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/29861</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization, Blinding description: In this study, participants randomly divided into omega-3 and placebo groups, and patients are unaware of being given placebo or omega-3. The doctor is unaware of which omega-3 patients and which placebo are receiving, and the investigator who is responsible for collecting data and analyzing the data is unaware of which patients received placebo and which omega-3s.</study_design>
      <phase>3</phase>
      <hc_freetext>parkinson.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Twenty-two people in the intervention group (including daily two capsules of omega-3 capsules with an EPA of 180mg and DHA of 120mg from the Zahravi Pharmaceuticals Company). Intervention 2: Control group: Twenty-two people in the placebo group (two capsules each day, in combination with soy oil, from Zahrawi Pharmaceuticals Company) will be placed.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Publish primary and raw results of samples

When:
Then finish and publish the draft articles

To whom:
Academic researchers

Conditions:
With the permission of the researcher of the project and the sponsor of the project, the Nutrition Research Center and the Research Deputy of the University-

Where to obtain:
Research Center for Nutrition Researchers

How to obtain:
In-person attendance and obtaining relevant permissions _ Phone call

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Bahram Pourghasem Gargari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golghast St. - Attar Neyshaburi St. - Faculty of Nutrition and Food Sciences</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614711</zip>
        <telephone>+98 41 3335 7580</telephone>
        <email>pourghassemb@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Bahram Pourghasem Gargari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golghast St., Attar Neyshaburi St., Faculty of Nutrition and Food Sciences</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614711</zip>
        <telephone>+98 41 3335 7580</telephone>
        <email>pourghassemb@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Those who have Parkinson's diagnosis by a neurologist
Those aged 50-70
People who do not use aspirin or another anticoagulant, or statin</inclusion_criteria>
      <agemin>50 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Unwillingness to cooperate
Patients who already took Omega-3 (6 months ago)
Patients who have depression or psychosis or have another inflammatory disease
Patients who are unable to take supplementation due to digestive problems or allergic reactions
Patients who smoke and drink alcohol</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></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: Twenty-two people in the intervention group (including daily two capsules of omega-3 capsules with an EPA of 180mg and DHA of 120mg from the Zahravi Pharmaceuticals Company)</i_keyword>
      <i_keyword>Control group: Twenty-two people in the placebo group (two capsules each day, in combination with soy oil, from Zahrawi Pharmaceuticals Company) will be placed</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Serum levels of IL-1B. Timepoint: The beginning and the end of the study. Method of measurement: ELISA KIT.</prim_outcome>
      <prim_outcome>Serum levels of IL-6. Timepoint: The beginning and the end of the study. Method of measurement: ELISA KIT.</prim_outcome>
      <prim_outcome>Serum levels of TNF-a. Timepoint: The beginning and the end of the study. Method of measurement: ELISA KIT.</prim_outcome>
      <prim_outcome>Serum levels of IL-10. Timepoint: The beginning and the end of the study. Method of measurement: ELISA KIT.</prim_outcome>
      <prim_outcome>Serum levels of TG. Timepoint: The beginning and the end of the study. Method of measurement: LBL KIT.</prim_outcome>
      <prim_outcome>Serum levels of HDL. Timepoint: The beginning and the end of the study. Method of measurement: LBL KIT.</prim_outcome>
      <prim_outcome>Serum levels of LDL. Timepoint: The beginning and the end of the study. Method of measurement: By the formula.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Check for food. Timepoint: At first and during the study. Method of measurement: A 24-hour recall questionnaire and MNA questionnaire MNA.</sec_outcome>
      <sec_outcome>Physical activity review. Timepoint: At the beginig of the study. Method of measurement: RAPA questionnaire.</sec_outcome>
      <sec_outcome>Anthropometric Indicators. Timepoint: The beginning and the end of the study. Method of measurement: Impedance bi-electric system.</sec_outcome>
      <sec_outcome>BMI. Timepoint: The beginning and the end of the study. Method of measurement: By the formula.</sec_outcome>
      <sec_outcome>Serum Alb level. Timepoint: Beginning of study. Method of measurement: Enzymatic.</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>2018-03-11</approval_date>
        <contact_name>کمیته اخلاق دانشکده تغذیه و علوم غذایی تبریز</contact_name>
        <contact_address>تبریز، خیابان گلگشت ، دانشگاه علوم پزشکی تبریز ، ساختمان مرکزی شماره 2 تبریز East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
