<?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>IRCT20190423043359N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-08-15</date_registration>
      <primary_sponsor>Razi University</primary_sponsor>
      <public_title>Effect of aerobic training and vitamin D supplementation on liver Fat, liver enzymes and lipid profile</public_title>
      <acronym></acronym>
      <scientific_title>Effect of aerobic training and vitamin D supplementation on liver Fat, liver enzymes and lipid profile in elderly women with nonalcoholic fatty liver and vitamin D deficiency</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-12-12</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/39065</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Factorial, Purpose: Health service research, Randomization description: Forty subjects will be randomly divide into four groups includes Aerobic training (AT, n=10); Vitamin D supplementation (Vit D, n=10); Aerobic training with vitamin D supplements (AT+Vit D, n=10); and control (C, n=10) using statistical software. Each participant will have an equal chance of being in each group, and researchers and participants in the study will not be able to predict the type of intervention they receive.</study_design>
      <phase>1</phase>
      <hc_freetext>Non-alcoholic fatty liver disease.</hc_freetext>
      <i_freetext>Intervention 1: The aerobic training + vitamin D supplementation Intervention will be consists of 20-40 minutes of aerobic exercise at 60% - 75% of HRmax, 3 times a week for eight weeks and vitamin D supplementation will be receiving vitamin D (∼50000 IU • week for eight weeks). Intervention 2: Intervention group: Aerobic training consists of 20-40 minutes of aerobic exercise at 60% - 75% of HRmax, 3 times a week for eight weeks. Intervention 3: Intervention group: Vitamin  D supplementation includes receiving vitamin D (∼50000 IU • week for eight weeks). Intervention 4: Control group: receiving placebo and no aerobic training for eight weeks.</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 will be record  in the SPSS software and will be available.

When:
Availability will start nine months after publishing all papers

To whom:
Only available for researchers in academic and scientific institutions

Conditions:
All data can be used as reference

Where to obtain:
Zahra.hoseinir@gmail.com

How to obtain:
If the explanation for data request would be convincing it will be given in 3 days.

Comments:
not having any</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Rastegar Hoseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.9, Taqh-Bostan Ave, University Blvd, Razi University.</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6714967346</zip>
        <telephone>+98 83 3428 3272</telephone>
        <email>Rastegar.hoseini@gmail.com</email>
        <affiliation>Razi University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Rastegar Hoseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bagh-abrisham Blvd, Razi University</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6714967346</zip>
        <telephone>+98 988334233267</telephone>
        <email>Rastegar.hoseini@gmail.com</email>
        <affiliation>Razi University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Ultrasound (US) confirmation of being in second or third grade of NAFLD and certified by an internist
25-OHD serum levels between 10 and 20 ng/ml
Being in second or third grade of NAFLD
Not having a specific diet and regular exercise program in the past year</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>65 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Significant consumption of alcohol more than 20 gr per day
Presence of other liver diseases (B and C hepatitis)
Other disorders such as autoimmune hepatitis, joint disease, celiac and Wilson disease, coronary artery disease, kidney failure, hypothyroidism
Surgical treatment of obesity or severe weight loss
Presence of any other chronic disease or skeletal disorders</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>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The aerobic training + vitamin D supplementation Intervention will be consists of 20-40 minutes of aerobic exercise at 60% - 75% of HRmax, 3 times a week for eight weeks and vitamin D supplementation will be receiving vitamin D (∼50000 IU • week for eight weeks).</i_keyword>
      <i_keyword>Intervention group: Aerobic training consists of 20-40 minutes of aerobic exercise at 60% - 75% of HRmax, 3 times a week for eight weeks.</i_keyword>
      <i_keyword>Intervention group: Vitamin  D supplementation includes receiving vitamin D (∼50000 IU • week for eight weeks).</i_keyword>
      <i_keyword>Control group: receiving placebo and no aerobic training for eight weeks</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Liver fat levels. Timepoint: Evaluation of fatty liver grade prior to the intervention and 24-48 h after intervention finished. Method of measurement: Using ultrasound (US).</prim_outcome>
      <prim_outcome>Vitamin D levels. Timepoint: Prior to the beginning and at the end of the study. Method of measurement: By blood sampling.</prim_outcome>
      <prim_outcome>Anthropometric indices. Timepoint: Before the study starts and after the study ends. Method of measurement: Using INBODY test.</prim_outcome>
      <prim_outcome>Lipid profile. Timepoint: Before the study starts and after it ended. Method of measurement: Blood sampling.</prim_outcome>
      <prim_outcome>Serum levels of liver enzymes. Timepoint: Before the study starts and after it ended. Method of measurement: Blood sampling.</prim_outcome>
      <prim_outcome>Glucose and insulin levels. Timepoint: Before the study starts and after it ended. Method of measurement: Blood sampling.</prim_outcome>
      <prim_outcome>Blood pressure. Timepoint: Before the study starts and after it ended. Method of measurement: Digital sphygmomanometer.</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>Razi University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-03-06</approval_date>
        <contact_name>Ethics committee of Kermanshah  University of Medical Sciences</contact_name>
        <contact_address>No. 8, Beheshti Blvd, Kermanshah Province, Kermanshah University of Medical Sciences. Kermanshah Kermanshah Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
