<?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>IRCT20200420047141N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-04-24</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the effect of vitamin D3 supplementation in doses of 1000 and 3000 IU / day on hyperglycemic control, wound healing,wound infection and sepsis incidence and length of stay in hospital in burn patients</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effect of vitamin D3 supplementation in doses of 1000 and 3000 IU / day on hyperglycemic control, wound healing,wound infection and sepsis incidence and length of stay in hospital in burn patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-04-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>54</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/47310</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Supportive, Randomization description: Https://www.sealedenvelope.com was used to randomly enter study participants. With the help of this site, for 54 participants in three defined groups A (group receiving 3000 IU of vitamin D daily), B (group receiving 1000 IU of vitamin D daily) and C (control group), the random order of entry in the study was determined, Blinding description: Participants enter the study with a personal satisfaction form and all study cases are explained to them. However, he does not know in which group and for what purpose he entered. Before starting the study, the patient will be told that he or she will not be provided with any information.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Burn patients.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:The first group receives a dose of 1000IU vitamin D from Flexan on a daily basis and orally from the time of admission until discharge from the hospital. Intervention 2: Intervention group: The second group receives a dose of 3000IU vitamin D from Flexan on a daily basis and orally from the time of admission until discharge from the hospital. (To access this dose, each patient will receive a 1000IU perl and a 2000IU perl per day.). Intervention 3: Control group: No supplements.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Due to the financial support of this research project carried out by Ahwaz Jundishapur University of Medical Sciences, it will be allowed to publish study data in the form of an article after the end of the intervention.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Elaheh Ghadimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Gulestan, Arian1 Building</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6136753591</zip>
        <telephone>+98 61 3337 1272</telephone>
        <email>ghadimi.elaheh1996@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Anahita Mansoori</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nutrition Department, Ahvaz Jundishapur University of Medical Science, Golestan highway</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6135715794</zip>
        <telephone>+98 61 3336 2414</telephone>
        <email>mansoori-a@ajums.ac.ir</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age group 50_18 years
Burns 50-20%
Second and third degree burns
At least two weeks in the hospital according to the doctor's prognosis
Satisfaction of the individual
Absence of chronic diseases such as diabetes and high blood pressure and chronic kidney disease
No supplement with Vit D in the last 6 months
Lack of disorders such as hypoparathyroidism, hyperthyroidism, tumors and bone disease
Not receiving sex hormones to treat osteoporosis
Patient awareness and ability to answer questionnaire questions
Able to receive oral vitamin</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Diagnosis of the relevant physician and discretion to discontinue the supplement due to clinical problems created in the patient
The patient's reluctance to continue studying
Reduce awareness and ability to answer questionnaire questions
The patient's death</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>T30-2, T30</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Burn of second degree, body region unspecified, Burn of third degree, body region unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:The first group receives a dose of 1000IU vitamin D from Flexan on a daily basis and orally from the time of admission until discharge from the hospital.</i_keyword>
      <i_keyword>Intervention group: The second group receives a dose of 3000IU vitamin D from Flexan on a daily basis and orally from the time of admission until discharge from the hospital. (To access this dose, each patient will receive a 1000IU perl and a 2000IU perl per day.)</i_keyword>
      <i_keyword>Control group: No supplements</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Hyperglycemic control. Timepoint: At least twice a week. Method of measurement: Blood sampling in fasting mode.</prim_outcome>
      <prim_outcome>Wound healing. Timepoint: Before the start of the intervention, 7 days and 14 days after the intervention. Method of measurement: Bates-jensenWound assessment tool.</prim_outcome>
      <prim_outcome>Infection of the wound and sepsis. Timepoint: On the fifth day of hospitalization. Method of measurement: Biopsy of wound depth and blood culture.</prim_outcome>
      <prim_outcome>The length of hospitalisation. Timepoint: From admission to discharge. Method of measurement: Count the number hospitalisation days.</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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-02-24</approval_date>
        <contact_name>Ethics committee of Jundishapur university of Medical Sciences</contact_name>
        <contact_address>Golestan street, Arian1 building Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
