<?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>IRCT20201130049538N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-07-05</date_registration>
      <primary_sponsor>Razi University</primary_sponsor>
      <public_title>Short-term effect of vitamin D on liver enzymes and lipid profile in response to exhausting eccentric exercise</public_title>
      <acronym></acronym>
      <scientific_title>Alterations of liver enzymes and lipid profile in response to exhausting eccentric exercise after short-term vitamin D supplementation in the overweight female with non-alcoholic fatty liver</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-05-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/55563</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Basic scienece, Randomization description: In this study, simple random sampling method will be used; And because the study population is small, the lottery method is used, That is, the names of the people are written on a piece of paper and placed inside the box, then the papers are taken out one by one until the desired sample size is complete, Blinding description: In this study, participants and health care personnel will be unaware of the type of intervention each patient receives. It should be noted that only the lead researcher will be aware of the intervention received for each patient.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Non-alcoholic fatty liver disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Fourteen subjects, Vitamin D supplementation (including receiving vitamin D from Zahravi Pharmaceutical Company, at the rate of 2000 units per day for six weeks), Exhaustive test and negative slope on the treadmill for two sessions (one session before supplementation and one session after supplementation), Control the intensity of exercise using a polar heart rate monitor and the Borg index, Blood sampling in four rounds. The first and second stages of sampling before and after the first training protocol and the third and fourth stages of sampling after the completion of the second training protocol. Intervention 2: Control group: Fourteen subjects, Receive a placebo containing paraffin made by Zahravi Pharmaceutical Company of Iran (daily for six weeks) which is similar to vitamin D supplement in terms of shape, color, smell and taste. Exhaustive test and negative slope on the treadmill for two sessions (one session before supplementation and one session after supplementation), Control the intensity of exercise using a polar heart rate monitor and the Borg index, Blood sampling in four rounds. The first and second stages of sampling before and after the first training protocol and the third and fourth stages of sampling after the completion of the second training protocol.</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.rahimpour73@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 3423 3267</telephone>
        <email>R.hoseini@razi.ac.ir</email>
        <affiliation>Razi Univeristy</affiliation>
      </contact>
      <contact>
        <type>scientific</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>008334233267</telephone>
        <email>R.hoseini@razi.ac.ir</email>
        <affiliation>Razi University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Overweight women with non-alcoholic fatty liver
Age 20 to 30 years
Body mass index above 25 to 29.99
Detection of non-alcoholic fatty liver by ultrasound
Vitamin D deficiency (25 levels of hydroxyvitamin D below 30 nanomoles / liter)</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>30 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Muscle injury
Uncontrolled intake of vitamin D supplements
Doing regular exercise
smoking</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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Fourteen subjects, Vitamin D supplementation (including receiving vitamin D from Zahravi Pharmaceutical Company, at the rate of 2000 units per day for six weeks), Exhaustive test and negative slope on the treadmill for two sessions (one session before supplementation and one session after supplementation), Control the intensity of exercise using a polar heart rate monitor and the Borg index, Blood sampling in four rounds. The first and second stages of sampling before and after the first training protocol and the third and fourth stages of sampling after the completion of the second training protocol.</i_keyword>
      <i_keyword>Control group: Fourteen subjects, Receive a placebo containing paraffin made by Zahravi Pharmaceutical Company of Iran (daily for six weeks) which is similar to vitamin D supplement in terms of shape, color, smell and taste. Exhaustive test and negative slope on the treadmill for two sessions (one session before supplementation and one session after supplementation), Control the intensity of exercise using a polar heart rate monitor and the Borg index, Blood sampling in four rounds. The first and second stages of sampling before and after the first training protocol and the third and fourth stages of sampling after the completion of the second training protocol.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Lipid profile. Timepoint: Prior to the beginning and at the end of the study. Method of measurement: By blood sampling.</prim_outcome>
      <prim_outcome>Serum levels of liver enzymes. Timepoint: Prior to the beginning and at the end of the study. Method of measurement: By blood sampling.</prim_outcome>
      <prim_outcome>Glucose and insulin levels. Timepoint: Prior to the beginning and at the end of the study. Method of measurement: By blood sampling.</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>2021-02-24</approval_date>
        <contact_name>Ethics committee of Kermanshah Razi University</contact_name>
        <contact_address>No.9, Taqh-Bostan Ave, University Blvd, Razi University. Kermanshah Kermanshah Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
