<?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>IRCT20200314046774N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-06-12</date_registration>
      <primary_sponsor>Ghoum University of Medical Sciences</primary_sponsor>
      <public_title>treatment of COVID-19 whit vitamin A</public_title>
      <acronym></acronym>
      <scientific_title>Assessment of vitamin A effectiveness on COVID-19 patients and treatment outcomes referred to health centers of Qom province</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-05-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>94</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/46519</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, 100 patients with covid 19 will be randomly divided into two groups. The selection of groups will be based on the fact that individuals will be assigned to groups based on block randomization. Block size 4 is considered. So we will have four blocks of four, including AB, AABB, BAAB, ABBA, BABA, BBAA, AB. The selection of each block will also be random and will be done using dice. For example, if the number 3 comes in the dice roll, the BBAA block is considered, so the first two patients are treated with B and the next two patients with A treatment. The dice will be thrown 25 times to complete the allocation of patients to treatment groups. Also, treatment allocation to groups A and B will be based on accident (coin toss), Blinding description: The statistical physician only had access to medical information, and the nurse, physician, and patient were blind.
On the box of real and placebo drugs, codes were written by a statistician and epidemiologist, and the drugs were given to patients by accident, but the doctor, nurse, and patient were unaware of their contents.
The codes were provided to the physician.</study_design>
      <phase>3</phase>
      <hc_freetext>covid-19.</hc_freetext>
      <i_freetext>Intervention 1: Intervention Group: "Consumption of Iranian Oral Vitamin A in the name of Ovigel Company 200,000 units today and repeat it tomorrow and then control the clinical and laboratory symptoms on the first, third, fifth, seventh, fourteenth and fourteenth days. Check the test: INR, LDH, wBC, PLT, LYMPH, CRP, CPK, Cr, Hb n need mechanical ventilation to check vitamin A side effects. Intervention 2: Control group: receives exactly four in appearance similar to the vitamin A capsule (drug Gul) and the next day the same thing is repeated and then the control of clinical symptoms and Laboratory test on the first, third, fifth, seventh, fourteenth, fourteenth day of the test: INR, LDH, wBC, PLT, LYMPH, CRP, CPK, Cr, Hb n.</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:
Part of the data is accessible

When:
3 months after printing the results

To whom:
Researchers working in academic and scientific institutions

Conditions:
Phone call with Dr. Majid FarhadiFard at 09127521134

Where to obtain:
Phone call with Dr. Majid FarhadiFard at 09127521134

How to obtain:
Phone call with Dr. Majid FarhadiFard at 09127521134

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Majid Farhadifard</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 10, Alley 13,Avenue Emam Khomeini,  Qom,Iran</address>
        <city>Qom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3718913997</zip>
        <telephone>+98 25 3662 0845</telephone>
        <email>majidfarhadifard@yahoo.com</email>
        <affiliation>Ghoum University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Majid Farhadifard</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 10, Alley 13, Emam Khomeini avenue, Qom, Iran</address>
        <city>Qom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3718913997</zip>
        <telephone>+98 25 3662 0845</telephone>
        <email>majidfarhadifard@yahoo.com</email>
        <affiliation>Ghoum University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All adult patients were hospitalized with covid_19 who were hospitalized for at least the first three days</inclusion_criteria>
      <agemin>1 year</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnant women
who with high cerebrospinal fluid pressure
People with malnutrition (celiac disease, short bowel syndrome, chronic pancreatitis, and impaired fat and anti-obesity and bariatric surgery)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>U07.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Use this code when COVID-19 has been confirmed by laboratory testing irrespective of severity of clinical signs or symptoms. Use additional code, if desired, to identify pneumonia or other manifestations.</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: "Consumption of Iranian Oral Vitamin A in the name of Ovigel Company 200,000 units today and repeat it tomorrow and then control the clinical and laboratory symptoms on the first, third, fifth, seventh, fourteenth and fourteenth days. Check the test: INR, LDH, wBC, PLT, LYMPH, CRP, CPK, Cr, Hb n need mechanical ventilation to check vitamin A side effects</i_keyword>
      <i_keyword>Control group: receives exactly four in appearance similar to the vitamin A capsule (drug Gul) and the next day the same thing is repeated and then the control of clinical symptoms and Laboratory test on the first, third, fifth, seventh, fourteenth, fourteenth day of the test: INR, LDH, wBC, PLT, LYMPH, CRP, CPK, Cr, Hb n.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Rate of O2 saturation. Timepoint: 1-3-5-7-10-14. Method of measurement: PCR, CT scan and clinical symptoms.</prim_outcome>
      <prim_outcome>Clinical symptoms. Timepoint: 1-3-5-7-10-14. Method of measurement: PCR, CT scan and clinical symptoms.</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>Ghoum University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-04-18</approval_date>
        <contact_name>Ethics committee of qom University of Medical Sciences</contact_name>
        <contact_address>No10,alley 2, avenue13, emam khomeini street, qom,iran qom Ghoum Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
