<?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>IRCT20200319046819N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-04-04</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>supplementation in COVID-19</public_title>
      <acronym></acronym>
      <scientific_title>Impact of vitamin B, A, D, E, C supplementation on improvement and mortality rate in patients with COVID-19 admitted in intensive care unit</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-04-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/46838</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: blocking randomization, Blinding description: Patients are unaware of being placed in the intervention or control group after declaration of consent. All treatment staff are aware of the patients in which group due to the specific conditions of the ICU and the absence of placebo for control group.</study_design>
      <phase>3</phase>
      <hc_freetext>COVID-19.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Vitamin supplementation in order (ampoules): 25,000 international units of vitamin A daily, 600,000 international units of vitamin D once during the intervention time, 300 international units of vitamin E, 2 times a day, 500 mg of vitamin C, 4 times a day and B vitamins in the form of one Soluvit ampoule in a day. The control group does not receive any supplement or placebo. In this study, the duration of supplementation and evaluation of patients is one week .Except for Soluvit (Fresenius Kabi New Zealand) , all supplements are made in Iran. Soluvit: Thiamine nitrate 3.1 mg, Sodiumriboflavine phosphate 4.9 mg(corresponding to Vitamin B2 3.6mg), Nicotinamide 40 mg,Pyridoxine hydrochloride 4.9 mg(corresponding to Vitamin B6 4.0mg), Sodium pantothenate 16.5 mg(corresponding to Pantothenic acid15 mg), Sodium ascorbate 113 mg(corresponding to Vitamin C 100mg), Biotin 60 μg, Folic acid 400 μg,Cyanocobalamin 5 μg,. Intervention 2: Control group: no 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>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 We have not yet reviewed with other colleagues.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sama Bitarafan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Floor 4, Iranian Center of Neurological Research biulding, Imam Khomeini Hospital, Keshavarz Blvd, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733141</zip>
        <telephone>+98 21 6694 8899</telephone>
        <email>Bitarafans@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sama Bitarafan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Floor 4, Iranian Center of Neurological Research biulding, Imam Khomeini Hospital, Keshavarz Blvd, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733141</zip>
        <telephone>+98 21 6694 8899</telephone>
        <email>Bitarafans@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 20 and 60 years
Both males and females
COVID-19 clinical or definitive diagnosis
Satisfaction with the study
patient do not participate in other trial designs
BMI: 18.5-30 -
Lack of renal and hepatic abnormalities</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with specific and rare viral diseases such as HIV etc.
Patients have been undergoing chemotherapy for the past month
Any other patients that the specialist knows to be unique.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>U07.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>COVID-19</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: Vitamin supplementation in order (ampoules): 25,000 international units of vitamin A daily, 600,000 international units of vitamin D once during the intervention time, 300 international units of vitamin E, 2 times a day, 500 mg of vitamin C, 4 times a day and B vitamins in the form of one Soluvit ampoule in a day. The control group does not receive any supplement or placebo. In this study, the duration of supplementation and evaluation of patients is one week .Except for Soluvit (Fresenius Kabi New Zealand) , all supplements are made in Iran. Soluvit: Thiamine nitrate 3.1 mg, Sodiumriboflavine phosphate 4.9 mg(corresponding to Vitamin B2 3.6mg), Nicotinamide 40 mg,Pyridoxine hydrochloride 4.9 mg(corresponding to Vitamin B6 4.0mg), Sodium pantothenate 16.5 mg(corresponding to Pantothenic acid15 mg), Sodium ascorbate 113 mg(corresponding to Vitamin C 100mg), Biotin 60 μg, Folic acid 400 μg,Cyanocobalamin 5 μg,</i_keyword>
      <i_keyword>Control group: no placebo</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>WBC, CRP, IL6,TNF-α, IFN-G ، ESR. Timepoint: Before and after intervention. Method of measurement: Laboratory blood test.</prim_outcome>
      <prim_outcome>Intensity of pulmonary involvement. Timepoint: Before and after intervention. Method of measurement: CT scan.</prim_outcome>
      <prim_outcome>Mortality. Timepoint: Before and after intervention. Method of measurement: Observation.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Body Mass Index. Timepoint: Before and after intervention. Method of measurement: Measuring weight and height and using the formula.</sec_outcome>
      <sec_outcome>Duration of hospitalization. Timepoint: Before and after intervention. Method of measurement: Observation.</sec_outcome>
      <sec_outcome>Saturation percentage of blood oxygen. Timepoint: Before and after intervention. Method of measurement: Oxymeter.</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>2020-04-01</approval_date>
        <contact_name>National Committee on Ethics in Tehran university of medical sciencies</contact_name>
        <contact_address>Block A, Central Headquarters of Ministry of Health and Medical Education, Iran Sima Street, between South Flamak and Zarafshan, Qods Town (West), Tehran, Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
