<?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>IRCT2013060411763N8</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-09-12</date_registration>
      <primary_sponsor>Food Security Research Center</primary_sponsor>
      <public_title>Effect of vitamin D supplementation on inflammatory markers, liver function, lipid profile, body composition, and sonographic findings in patients with NAFLD</public_title>
      <acronym></acronym>
      <scientific_title>Effect of vitamin D supplementation on inflammatory markers, liver function, lipid profile, body composition, and sonographic findings in patients with NAFLD</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-06-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/11921</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>non alcohlic fatty liver disease.</hc_freetext>
      <i_freetext>Intervention 1: This randomized clinical trial will be conducted in parallel. The objective of this study is the low number of participants in this study, 60 patients with NAFLD are referred to the Medical Research Center for Gastroenterology.The consent of the individuals participating in the study will be made in the experimental group during the 10-week study, which included a week Pearl vitamin D supplements are vitamin D 50,000 IU  receive.The control group during the 10 weeks, each week placebo in terms of shape, color is similar to vitamin D supplements. The study followed patients for vitamin D supplement use,Weekly basis with the individuals contacted by telephone and SMS reminders to be a supplement to these people. To assess the level of acceptance of 25-hydroxy vitamin D supplements Gyy the size of the trucks will be used to study. Intervention 2: Palcebo.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>mahdi foroughi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>isfahan university medical science, school of nutrition</address>
        <city>isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 1523 6352</telephone>
        <email>MFOROGHI38@YAHOO.COMASKARI@MUI.AC.IR</email>
        <affiliation>food security research center</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>gholamreza askari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>isfahan university medical science, school of nutrition</address>
        <city>isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 1792 2658</telephone>
        <email>askari@mui.ac.ir</email>
        <affiliation>isfahan university medical science, school of nutrition</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria were stable increases in AST and ALT greater than 50 U / L and metabolic syndrome, which includes waist circumference greater than 40 inches for men and greater than 35 inches for women, Triglycerides greater than or equal to 150 mg /dl, HDL less than 40 mg / dl for men and less than 50 mg/dl for women, Blood pressure greater than or equal to 85/135 mmHg, fasting blood glucose greater than or equal to 110 mg / dl. The participants in this study have not hepatitis C, B and Wilson disease and no history of chronic liver disease, a disease that affects the gallbladder and bile ducts. The absence of gestational, diabetes mellitus type 1 and 2, use of drugs affecting the levels of ALT (valproic acid, tamoxifen, HMG-COA reductase inhibitors, metformin, ACE 1 and ACER 1). They do not follow the diet and weight loss because weight loss effective vitamin d. Exclusion criteria included hospitalization, lack of cooperation in the study and with an acute illness.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>k76</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other diseases of liver</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>This randomized clinical trial will be conducted in parallel. The objective of this study is the low number of participants in this study, 60 patients with NAFLD are referred to the Medical Research Center for Gastroenterology.The consent of the individuals participating in the study will be made in the experimental group during the 10-week study, which included a week Pearl vitamin D supplements are vitamin D 50,000 IU  receive.The control group during the 10 weeks, each week placebo in terms of shape, color is similar to vitamin D supplements. The study followed patients for vitamin D supplement use,Weekly basis with the individuals contacted by telephone and SMS reminders to be a supplement to these people. To assess the level of acceptance of 25-hydroxy vitamin D supplements Gyy the size of the trucks will be used to study</i_keyword>
      <i_keyword>Palcebo</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The severity of fatty liver using abdominal ultrasound at baseline and end of study. Timepoint: Baseline and 10 weeks after intervention. Method of measurement: ultrasound.</prim_outcome>
      <prim_outcome>AST and ALT liver enzymes. Timepoint: Baseline and 10 weeks after intervention. Method of measurement: Blood tests.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Body composition. Timepoint: baseline and 10 weeks after intervention. Method of measurement: instrument body composition.</sec_outcome>
      <sec_outcome>FBS. Timepoint: baseline and 10 weeks after intervention. Method of measurement: blood test.</sec_outcome>
      <sec_outcome>Lipid profile. Timepoint: baseline and 10 weeks after intervention. Method of measurement: blood test.</sec_outcome>
      <sec_outcome>CRP. Timepoint: baseline and 10 weeks after intervention. Method of measurement: blood test.</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>Food Security Research Center</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-06-09</approval_date>
        <contact_name>isfahan university medical science</contact_name>
        <contact_address>isfahan isfahan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
