<?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>IRCT20211220053469N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-12-29</date_registration>
      <primary_sponsor>Zahedan University of Medical Sciences</primary_sponsor>
      <public_title>The assessment of the effect of omega-3 supplementation on serum interleukin-6, alpha tumor necrosis factor and depression status in bipolar patients</public_title>
      <acronym></acronym>
      <scientific_title>The assessment of the effect of omega-3 supplementation on serum interleukin-6, alpha tumor necrosis factor and depression status in bipolar patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-01-27</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/60849</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization of patients is conducted based on permuted block stratified randomization. The patients are classed based on age and gender. The patients are randomly selected based on quadruplet blocks (two groups A &amp; B and two replications for each group). The blocks are designed by help of R software (version of 4.02), Blinding description: Double blinding is used in the current study, so that person giving supplements and intervention, technician responsible for registration will not be informed study details.</study_design>
      <phase>3</phase>
      <hc_freetext>Bipolar disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  30 patients with bipolar disorder, in addition to their usual treatment, will receive 2 omega 3 capsules daily (made by Barij Pharmaceutical Company), each capsule containing 1 gram of omega 3, for 8 weeks, which is recommended to be taken with lunch and dinner. Intervention 2: Control group: 30 patients with bipolar disorder, in addition to their usual treatment, will receive 2 placebo capsules containing edible paraffin oil  (made by Barij Pharmaceutical Company) , each capsule containing 1 gram of edible paraffin oil , for 8 weeks, which is recommended to be taken with lunch and dinner.</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 I need more time for making decision.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hadi Eslahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Republic Boulevard., 18 meters Golha Street., Golha 3., Milan 2., right., second side., left</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9816993353</zip>
        <telephone>+98 54 3348 4862</telephone>
        <email>hadi_eslahi2015@zaums.ac.ir</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hadi Eslahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Republic Boulevard., 18 meters Golha Street., Golha 3., Milan 2., right., second side., left</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9816993353</zip>
        <telephone>+98 54 3348 4862</telephone>
        <email>hadi_eslahi2015@zaums.ac.ir</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The involvement with bipolar disease
Patients with minimum six months after onset of disease
Informed and freely consent for participation in the design by patient and family members.
The lack of receiving omega-3 supplement several months before of participation in the study
The lack of programmed surgery in three months future
The lack of consumption of drugs interfering with omega-3 such as anticoagulant drugs
The lack of high blood pressure
The lack of alcohol and drugs</inclusion_criteria>
      <agemin>16 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The change in drug dose and type
Sensitive reaction against omega-3
The consumption of lesser than 80% supplement
The involvement with inflammatory and infectious diseases
Withdrawal of the study for any reason</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F31.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Bipolar disorder, current episode depressed, mild or moderate severity</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:  30 patients with bipolar disorder, in addition to their usual treatment, will receive 2 omega 3 capsules daily (made by Barij Pharmaceutical Company), each capsule containing 1 gram of omega 3, for 8 weeks, which is recommended to be taken with lunch and dinner.</i_keyword>
      <i_keyword>Control group: 30 patients with bipolar disorder, in addition to their usual treatment, will receive 2 placebo capsules containing edible paraffin oil  (made by Barij Pharmaceutical Company) , each capsule containing 1 gram of edible paraffin oil , for 8 weeks, which is recommended to be taken with lunch and dinner.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Mean of interleukin 6. Timepoint: At the beginning of the study (before the intervention) and 60 days after the start of omega-3 supplementation. Method of measurement: Commercial Kit / ELISA.</prim_outcome>
      <prim_outcome>Mean of alpha tumor necrosis factor. Timepoint: At the beginning of the study (before the intervention) and 60 days after the start of omega-3 supplementation. Method of measurement: Commercial Kit / ELISA.</prim_outcome>
      <prim_outcome>Depression score on the Hamilton questionnaire. Timepoint: At the beginning of the study (before the intervention) and 60 days after the start of omega-3 supplementation. Method of measurement: Hamilton questionnaire.</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>Zahedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-12-25</approval_date>
        <contact_name>Ethics committee of Zahedan University of Medical Sciences</contact_name>
        <contact_address>Islamic Republic Boulevard, 18 meters Golha Street, Golha 3, Milan 2, right, second side, left Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
