<?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>IRCT20240702062312N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-07-31</date_registration>
      <primary_sponsor>The University of Kurdistan</primary_sponsor>
      <public_title>Leptin response to Training and Supplementation</public_title>
      <acronym></acronym>
      <scientific_title>The effects of two training program and vitamin D supplementation on lipid profile, leptin and body composition in obese adolescents with vitamin D deficiency</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-08-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>48</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/77716</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Factorial, Purpose: Health service research, Randomization description: A simple method of drawing a number randomly from a bag: The researcher assigns a number to each of the samples, then they are selected using the random number table   model and randomly assigned to one of the groups. For this, a number will be defined for each of the samples and a number for each of the groups and will be placed in separate bags. The first number that is randomly selected from the bag of samples will be placed in the first group that is selected from the bag of groups, and this will continue until all the samples are placed in the groups, Blinding description: Groups that use vitamin D and placebo will use capsules with the same shape, taste, and color, and only the researcher knows which groups will use vitamin D and which groups will use placebo. The jump rope + vitamin D, running on treadmill + vitamin D and vitamin D groups will use 2000 IU of vitamin D in capsule form daily, and the jump rope + placebo and running on treadmill + placebo groups will use one placebo capsule daily in the same way.</study_design>
      <phase>3</phase>
      <hc_freetext>Obesity.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: 3 sessions per week, 3 × 10 min interval running at 70–85% HRmax separated by 5 min active recovery running on a treadmill, for 8 weeks with 2000 units per day vitamin D supplementation. Intervention 2: Intervention group 2: 3 sessions per week, 3 × 10 min interval running at 70–85% HRmax separated by 5 min active recovery running on a treadmill, for 8 weeks with placebo. Intervention 3: Intervention group 3: 3 sessions per week, 30 min of exercise including 1 min of exercise with 30 seconds of rest at 60–90 jump/min jump rope for 8 weeks with 2000 units per day vitamin D supplementation. Intervention 4: Intervention group 4: 3 sessions per week, 30 min of exercise including 1 min of exercise with 30 seconds of rest at 60–90 jump/min jump rope for 8 weeks  with placebo. Intervention 5: Intervention group 5: Eight weeks of consumption of 2000 units per day vitamin D supplementation. Intervention 6: Control group: Non intervention.</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:
A part of the data, such as the information related to the main result or the like, can be shared.

When:
The access period starts 6 months after the results are published

To whom:
Researchers

Conditions:
Research in this field

Where to obtain:
naserrostamzadeh806@gmail.com

How to obtain:
By email

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dariush Sheikholeslami Vatani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pasdaran Blvd</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6617715175</zip>
        <telephone>+98 87 3366 4600</telephone>
        <email>d.vatani@uok.ac.ir</email>
        <affiliation>The University of Kurdistan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dariush Sheikholeslami Vatani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pasdaran Blvd</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6617715175</zip>
        <telephone>+98 87 3366 4600</telephone>
        <email>d.vatani@uok.ac.ir</email>
        <affiliation>The University of Kurdistan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Being male
Being at the age of 13-15 years old
Body mass index (BMI) more than 30 kg/m2
Vitamin D deficiency (less than 20 ng/ml)</inclusion_criteria>
      <agemin>13 years</agemin>
      <agemax>15 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Doing regular exercise in the last 3 months
Any illness or acute discomfort
Lack of consent of parents or legal guardians
Having a medical prohibition to participate in physical activity
Taking medicine and supplements in the last 3 months
Drug and alcohol addiction</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E66.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Obesity, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>Placebo</i_code>
      <i_code>N/A</i_code>
      <i_code>Placebo</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: 3 sessions per week, 3 × 10 min interval running at 70–85% HRmax separated by 5 min active recovery running on a treadmill, for 8 weeks with 2000 units per day vitamin D supplementation</i_keyword>
      <i_keyword>Intervention group 2: 3 sessions per week, 3 × 10 min interval running at 70–85% HRmax separated by 5 min active recovery running on a treadmill, for 8 weeks with placebo</i_keyword>
      <i_keyword>Intervention group 3: 3 sessions per week, 30 min of exercise including 1 min of exercise with 30 seconds of rest at 60–90 jump/min jump rope for 8 weeks with 2000 units per day vitamin D supplementation</i_keyword>
      <i_keyword>Intervention group 4: 3 sessions per week, 30 min of exercise including 1 min of exercise with 30 seconds of rest at 60–90 jump/min jump rope for 8 weeks  with placebo</i_keyword>
      <i_keyword>Intervention group 5: Eight weeks of consumption of 2000 units per day vitamin D supplementation</i_keyword>
      <i_keyword>Control group: Non intervention</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Serum level of leptin. Timepoint: At the beginning of the study and 8 weeks after the start of the study. Method of measurement: Blood sampling.</prim_outcome>
      <prim_outcome>Body fat percent. Timepoint: At the beginning of the study and 8 weeks after the start of the study. Method of measurement: Caliper.</prim_outcome>
      <prim_outcome>High density lipoprotein (HDL). Timepoint: At the beginning of the study and 8 weeks after the start of the study. Method of measurement: Blood sampling.</prim_outcome>
      <prim_outcome>Low density lipoprotein (LDL). Timepoint: At the beginning of the study and 8 weeks after the start of the study. Method of measurement: Blood sampling.</prim_outcome>
      <prim_outcome>Triglyceride (TG). Timepoint: At the beginning of the study and 8 weeks after the start of the study. Method of measurement: Blood sampling.</prim_outcome>
      <prim_outcome>Total cholesterol (TC). Timepoint: At the beginning of the study and 8 weeks after the start of the study. Method of measurement: 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>The University of Kurdistan</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-06-08</approval_date>
        <contact_name>Ethics committee of University of Kurdistan</contact_name>
        <contact_address>Pasdaran Blvd., Sanandaj Kurdistan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
