<?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>IRCT20191015045113N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-12-08</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of zinc supplementation on fatty liver</public_title>
      <acronym></acronym>
      <scientific_title>Effect of zinc supplementation on serum zinc status, lipid profile, liver enzymes (ALT, AST), insulin resistance, inflammatory markers and oxidative stress in non-alcoholic fatty liver patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/43583</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Samples were included in this study by simple randomization. In this way, patients were randomly assigned to one of the intervention and placebo groups after having met the inclusion criteria and obtaining written consent.That way the first patient in The intervention group and the next group are included in the control group.This is done until the end of the sample, Blinding description: The patient-level study and the outcome evaluator will be blinded.
Medication and placebo capsules are divided into two equal groups before filling on the basis of random number table by block method.
Only a researcher based on the initial stored form of randomized results can decode the contents of each capsule.
The person responsible for delivering the medication, the patient, the physician, and the outcome assessor will not be aware of the coding.
The results of the intervention and control groups will be delivered to the statistical analyst under the titles of groups A and B.</study_design>
      <phase>3</phase>
      <hc_freetext>Non Alcoholic Fatty Liver Disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Twenty - five patients with ultrasound - confirmed non - alcoholic fatty liver disease received a coated capsule containing 30 mg of Nature Made made at the Faculty of Pharmacy of Shiraz University of Medical Sciences for 8 weeks. Intervention 2: Control group: Twenty-five patients with ultrasound-approved non-alcoholic fatty liver were included for 8 weeks with a starch-coated capsule made at Shiraz University of Medical Sciences School of Pharmacy in terms of appearance, size, and color. ... with the complement of zinc they receive.</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:
All data is shared after unidentifiable people

When:
Start of access period 6 months after printing results

To whom:
For people working in science institutes

Conditions:
For meta-analysis studies

Where to obtain:
seyed mohammad amin rezaei
09177422832

How to obtain:
-The applicant can receive the file after up to one month after the call or email.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyed Mohammad Amin Rezaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Karkonan Doulat</address>
        <city>Gachsaran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7581359560</zip>
        <telephone>+98 74 3232 2519</telephone>
        <email>seyedamin.rezaei69@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyed Mohammad Amin Rezaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Karkonan Doulat</address>
        <city>Gachsaran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7581359560</zip>
        <telephone>+98 74 3232 2519</telephone>
        <email>seyedamin.rezaei69@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>-Attention to fatty liver confirmed by ultrasound
- Ages between 18 and 70 years
-Not consuming alcoholic beverages
- Lack of other liver diseases such as viral hepatitis, liver cirrhosis, Wilson's disease ...
- Lack of parenteral nutrition
-No diseases that affect the bile and bile ducts
- No severe weight loss 6 months ago
-Not taking medications that cause fatty liver (methotrexate, tamoxifen, valproate, etc.)
-No pregnancy and breastfeeding
- Lack of serum ALT levels more than 10 times the limit
- No chemotherapy during the past year
-Not taking any supplements containing zinc</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>People who have done chemotherapy over the past year
People with any biliary disease
People taking any supplements and drugs containing zinc
People who have had severe weight loss in the past 6 month
People taking any form of fatty liver medication</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K76.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Fatty (change of) liver, not elsewhere classified</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: Twenty - five patients with ultrasound - confirmed non - alcoholic fatty liver disease received a coated capsule containing 30 mg of Nature Made made at the Faculty of Pharmacy of Shiraz University of Medical Sciences for 8 weeks.</i_keyword>
      <i_keyword>Control group: Twenty-five patients with ultrasound-approved non-alcoholic fatty liver were included for 8 weeks with a starch-coated capsule made at Shiraz University of Medical Sciences School of Pharmacy in terms of appearance, size, and color. ... with the complement of zinc they receive.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Serum zinc. Timepoint: 8 weeks. Method of measurement: Blood sampling.</prim_outcome>
      <prim_outcome>Insulin resistance. Timepoint: 8 weeks. Method of measurement: Blood sampling.</prim_outcome>
      <prim_outcome>ALT. Timepoint: 8 Week. Method of measurement: blood sample.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Fasting blood sugar. Timepoint: 8 week. Method of measurement: blood sample.</sec_outcome>
      <sec_outcome>Serum total cholesterol. Timepoint: 8 week. Method of measurement: blood sample.</sec_outcome>
      <sec_outcome>Serum triglyceride. Timepoint: 8 Week. Method of measurement: blood sample.</sec_outcome>
      <sec_outcome>MDA. Timepoint: 8 week. Method of measurement: blood sample.</sec_outcome>
      <sec_outcome>Total Antioxidant Capacity (TAC). Timepoint: 8 week. Method of measurement: blood sample.</sec_outcome>
      <sec_outcome>Hs-CRP. Timepoint: 8 week. Method of measurement: blood sample.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Vice chancellor for research, Shiraz University of Medical Sciences</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Shiraz University of Medical Sciences</source_name>
      <source_name>Vice chancellor for research, Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-01-22</approval_date>
        <contact_name>Ethics committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Bahman Beigi Boulevard, Bibi Hakime Hospital shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
