<?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>IRCT20230123057193N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-10-29</date_registration>
      <primary_sponsor>Research assistant of Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of L-arginine supplementation on matabolic factors and stress oxidative indices in patients with Metabolic dysfunction-associated steatotic liver disease (MASLD)</public_title>
      <acronym></acronym>
      <scientific_title>The effect of L-arginine supplementation on matabolic factors and stress oxidative indices in patients with Metabolic dysfunction-associated steatotic liver disease (MASLD): a double-blind randomized controlled clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-10-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>44</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/79312</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: All subjects and researchers and healthcare personnel who are responsible for the care of patients will be unaware of the existing grouping until the end of the study; In such a way, the researcher and the person who takes the sample, like the study participants, are unaware of which patient will receive the vitamin pill or the placebo. Patients are also unaware of the type of pill received. Drugs and placebos are coded by a person who is completely unaware of the study process, and this code is placed in an envelope that indicates whether it is a drug or a placebo code. One group will receive drug A and one group will receive drug B.
  Also, pills containing L-arginine and placebo, which have the same color, smell, and size as the vitamin pill, will be given to the study subjects every 4 weeks by another person who has no knowledge of the research process. Hence, this study will be a double-blind study.
Placebo tablets contain starch and are completely similar to L-arginine tablets in terms of color, appearance and smell. Placebo tablets are also prepared by the same company that manufactures L-arginine, Blinding description: All subjects and researchers will be unaware of the existing grouping until the end of the study, and L-arginine supplement and placebo will be given to subjects once every 4 weeks by another person who has no knowledge of the research process. In order to evaluate the acceptance of the patients, a checklist will be prepared and given to the patients and they will be asked to record their daily consumption in it. In addition, in order to ensure the consumption of supplements, reminder messages will be sent to all patients every da.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Metabolic dysfunction-associated steatotic liver disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention group: The intervention group will receive 3000 mg of arginine daily (3 tablets of 1000 mg) with water for 8 weeks. Arginine tablets are purchased from Karen. All patients will be monitored for pill consumption with a daily checklist and recall messages. Intervention 2: Control group: People in the placebo group will take a pill that is completely similar to the L-arginine supplement in terms of appearance, color and smell, daily in the same way for 8 weeks. Placebo pills are purchased from Karen Company. All patients will be monitored for pill consumption with a daily checklist and recall messages.</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 Patient information will remain confidential. There is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>sorayia ebrahim pour koujan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Razi Hospital, Razi Dead End, Vahdat Islami Square, Vahdat Islami Street,Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1199663911</zip>
        <telephone>+98 21 5563 0553</telephone>
        <email>nutri.seam1@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sorayia ebrahim pour koujan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Razi Hospital, Razi Dead End, Vahdat Islami Square, Vahdat Islami Street,Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1199663911</zip>
        <telephone>+98 21 5563 0553</telephone>
        <email>nutri.seam1@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with metabolic disorder related to diagnosed steatotic liver disease without fibrosis and cap score below 310 and Metavir score below f1, which has been confirmed by a gastroenterologist.
BMI 25- 35
Age between 30-55</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnant and lactating
Chronic diseases such as cardiovascular, cancer, Alzheimer's, Parkinson's, and chronic kidney disease, history of stroke and heart attack, rheumatoid arthritis, diabetes, thyroid diseases, and other chronic diseases and menopause Based on the information provided by the individualBlood Pressure Medications
Thyroid Medications
Corticosteroids drug
Drugs affecting blood glucose levels
Anti-inflammatory supplements
Antioxidant supplements
Omega 3 consumption
Blood Pressure Medications
Taking antibiotics, antivirals and antifungals
Any history of alcohol and tobacco use</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: Intervention group: The intervention group will receive 3000 mg of arginine daily (3 tablets of 1000 mg) with water for 8 weeks. Arginine tablets are purchased from Karen. All patients will be monitored for pill consumption with a daily checklist and recall messages.</i_keyword>
      <i_keyword>Control group: People in the placebo group will take a pill that is completely similar to the L-arginine supplement in terms of appearance, color and smell, daily in the same way for 8 weeks. Placebo pills are purchased from Karen Company. All patients will be monitored for pill consumption with a daily checklist and recall messages.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Alanine transaminase, Aspartate aminotransferase. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Elisa.</prim_outcome>
      <prim_outcome>Low density lipoprotein, High density lipoprotein, Triglyceride, Total cholesterol. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Elisa.</prim_outcome>
      <prim_outcome>Fasting blood sugar, Fasting blood insulin. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Elisa.</prim_outcome>
      <prim_outcome>Malondialdehyde. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Elisa.</prim_outcome>
      <prim_outcome>Homeostatic Model Assessment for Insulin Resistance, Homeostasis Model Assessment of β-cell function, Quantitative insulin sensitivity check index. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Using the formula.</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>Research assistant of Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-09-30</approval_date>
        <contact_name>Tehran University of Medical Science</contact_name>
        <contact_address>Qods Street, Keshavarz Boulevard Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
