<?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>IRCT20200511047399N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-07-23</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Effect of omega-3 on diabetic patients with Covid-19</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effectiveness of omega-3 and Hydroxychloroquine on Inflammatory factors, liver enzymes and clinical symptoms in diabetic COVID-19 patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/48045</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Stratified Randomization method was used to control gender and BMI variables. BMI is considered normal (BMI= 18.5- 24.9) and abnormal (BMI≥ 25) and gender is considered as male and female, and thus four lists including women with normal BMI, women with abnormal BMI, men with normal BMI and men with abnormal BMI were considered. Patients were then divided into 2 groups by Permuted Block Randomization. In each separate list, the two-block modes (AB, BA) will be randomly assigned to each treatment order using a random number table. In each list, the order of treatment is determined and therefore, using the double blocks defined according to the random table, patients are placed in equal numbers in each group, Blinding description: the current study is a single-blinded clinical trial, in which the outcome assessor is not aware of each participant's group.</study_design>
      <phase>3</phase>
      <hc_freetext>Covid-19.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 3 capsules containing 2010 mg EPA and DHA + 2 capsules containing 400 mg Hydroxychloroquine. Intervention 2: Control group: 2 capsules containing 400 mg Hydroxychloroquine.</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 further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mina Abdolahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Amir-Alam hospital, Saadi St., Darvazeh Dolat STN., Enghelab St</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>12345678910</zip>
        <telephone>+98 21 6634 3352</telephone>
        <email>abdolahimina.n@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hamed Abdollahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Amir-Alam hospital, Saadi St., Darvazeh Dolat STN., Enghelab St</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>12345678910</zip>
        <telephone>009866343352</telephone>
        <email>h-abdollahi@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Body mass index equal to or more than 18.5
age equal to or more than 18
Diabetic patients diagnosed with covid-19 according to physician diagnosis  
Not consuming any particular diet or supplement as well as not doing any particular physical activity
Willingness to participate in the study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having a history or current diagnosis of inflammatory disorders including liver, kidney or thyroid abnormalities, pancreatitis, any malignancy or other conditions that impact inflammatory status
Patients who had regularly received omega-3 supplements during 3 months before our trial
Pregnancy
Lactating
Menopause
Patients with history of smoking (at-least 5 cigarette per day) or alcohol intake during 6 months before our trial
any abnormality in PTT, PT or INR tests</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>U07.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>COVID-19, virus not identified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: 3 capsules containing 2010 mg EPA and DHA + 2 capsules containing 400 mg Hydroxychloroquine</i_keyword>
      <i_keyword>Control group: 2 capsules containing 400 mg Hydroxychloroquine</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Erythrocyte sedimentation rate (ESR). Timepoint: In the baseline of the study and after 2 weeks supplementation with omega-3. Method of measurement: Automated erythrocyte sedimentation rate analyzer (ELECTA LAB S.r.l, Via Balzella, Italy).</prim_outcome>
      <prim_outcome>C-reactive protein. Timepoint: In the baseline of the study and after 2 weeks supplementation with omega-3. Method of measurement: Immunoturbidimetric method (Pars Azmun, Iran).</prim_outcome>
      <prim_outcome>Fatigue. Timepoint: In the baseline of the study and after 2 weeks supplementation with omega-3. Method of measurement: Self-reported questionnaire with sores ranging from 1 until 10.</prim_outcome>
      <prim_outcome>Body pain. Timepoint: In the baseline of the study and after 2 weeks supplementation with omega-3. Method of measurement: Self-reported questionnaire with sores ranging from 1 until 10.</prim_outcome>
      <prim_outcome>Appetite. Timepoint: In the baseline of the study and after 2 weeks supplementation with omega-3. Method of measurement: Self-reported questionnaire with sores ranging from 1 until 10.</prim_outcome>
      <prim_outcome>Olfactory. Timepoint: In the baseline of the study and after 2 weeks supplementation with omega-3. Method of measurement: Self-reported questionnaire with sores ranging from 1 until 10.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Alanine aminotransferase. Timepoint: In the baseline and after 2 weeks omega-3 supplementation. Method of measurement: Available valid diagnostic test kits (Crest Biosystems kits, India).</sec_outcome>
      <sec_outcome>Aspartate aminotransferase. Timepoint: In the baseline and after 2 weeks omega-3 supplementation. Method of measurement: Available valid diagnostic test kits (Crest Biosystems kits, India).</sec_outcome>
      <sec_outcome>Alkaline phosphatase. Timepoint: In the baseline and after 2 weeks omega-3 supplementation. Method of measurement: Available valid diagnostic test kits (Crest Biosystems kits, India).</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-05-31</approval_date>
        <contact_name>Ethics committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>Tehran University of Medical Sciences: No. 226, Poursina St., Qods St., Keshavarz Blvd Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
