<?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>IRCT20180805040703N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-10-20</date_registration>
      <primary_sponsor>Institute for Endocrine Science</primary_sponsor>
      <public_title>Effects of different dosages of vitamin D3 on anthropometric indices, metabolic, bone, and vascular parameters and body composition</public_title>
      <acronym></acronym>
      <scientific_title>Effects of different dosages of vitamin D3 on anthropometric indices, metabolic, bone, and vascular parameters and body composition in overweight or obese children and adolescents</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-06-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>327</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/33444</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Children and adolescents will be randomized using stratified block randomization method in each intervention group (2000 IU vitamin D, 1000 IU vitamin D, and 600 IU vitamin D), before which important confounders including sex (boy or girl), body mass index (overweight or obesity), and pubertal stage (pre-puberty and puberty) are determined. Eight strata including 3-blocks of A, B and C (3 intervention groups) are determined (ABC, BCA, CAB, ACB, BAC, CBA). Thus, at the end of the study, the three therapeutic groups in terms of confounding factors, including sex, body mass index, and pubertal stage will be the same and with an equal number of subjects, Blinding description: in this study participants were aware of dosage of vitamin D supplementation they received. but, the investigator was blind for randomization of participants. so there was no awareness of the dose received by each person.</study_design>
      <phase>3</phase>
      <hc_freetext>Condition 1: over weight and obesity, cardiovascular disease. Condition 2: vitamin D deficiency.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group1: 12 months oral vitamin D supplementation of 2000 IU/d (ZAHRAVI pharmaceutical company-Tabriz-Iran). Intervention 2: Intervention group2: 12 months oral vitamin D supplementation of 1000 IU/d (ZAHRAVI pharmaceutical company-Tabriz-Iran). Intervention 3: Control group: 12 months oral vitamin D supplementation of 600 IU/d (ZAHRAVI pharmaceutical company-Tabriz-Iran).</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 there is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Golaleh Asghari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 24 parvane Ave., Yaman Blvd., Velenjak Str., Chamran High way</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717413</zip>
        <telephone>+98 21 2243 2503</telephone>
        <email>g_asghari@hotmail.com</email>
        <affiliation>Institute for Endocrine Science</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Golaleh Asghari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.24, Parvane ave., Yaman Blvd., Velenjak str., Chamran high way</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717413</zip>
        <telephone>+98 21 2243 2503</telephone>
        <email>g_asghari@hotmail.com</email>
        <affiliation>Institute for Endocrine Science</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Willingness to cooperate
Age 6-13 years
Overweight or obesity (BMI ≥ 85th percentile national scale by age and sex)</inclusion_criteria>
      <agemin>6 years</agemin>
      <agemax>13 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Reluctance to cooperate in any stage of study
Use of any vitamin D supplements during the last six months
Identifying any types of liver diseases, kidney, cardiovascular and metabolic bone
Use of any drugs, affecting metabolism of vitamin D including glucocorticoids, steroids and anticonvulsants such as carbamazepine, phenytoin and phenobarbital
Following any weight loss diets during the past one year</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E66</hc_code>
      <hc_code>E55</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Overweight and obesity</hc_keyword>
      <hc_keyword>Vitamin D deficiency</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group1: 12 months oral vitamin D supplementation of 2000 IU/d (ZAHRAVI pharmaceutical company-Tabriz-Iran)</i_keyword>
      <i_keyword>Intervention group2: 12 months oral vitamin D supplementation of 1000 IU/d (ZAHRAVI pharmaceutical company-Tabriz-Iran)</i_keyword>
      <i_keyword>Control group: 12 months oral vitamin D supplementation of 600 IU/d (ZAHRAVI pharmaceutical company-Tabriz-Iran)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Carotid intima media thickness. Timepoint: before intervention, 6 and 12 months after intervention. Method of measurement: sonography.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>25 hydroxy vitamin D. Timepoint: before intervention, 6 and 12 months after intervention. Method of measurement: Electrochemiluminescence.</sec_outcome>
      <sec_outcome>Para thyroid hormon. Timepoint: before intervention, 6 and 12 months after intervention. Method of measurement: Electrochemiluminescence.</sec_outcome>
      <sec_outcome>Plasma insulin. Timepoint: before intervention, 6 and 12 months after intervention. Method of measurement: Electrochemiluminescence.</sec_outcome>
      <sec_outcome>Plasma glucose. Timepoint: before intervention, 6 and 12 months after intervention. Method of measurement: colorimetry.</sec_outcome>
      <sec_outcome>Lipid profile. Timepoint: before intervention, 6 and 12 months after intervention. Method of measurement: colorimetry.</sec_outcome>
      <sec_outcome>Body mass index. Timepoint: before intervention, 6 and 12 months after intervention. Method of measurement: calculation.</sec_outcome>
      <sec_outcome>Fat mass. Timepoint: before intervention, 6 and 12 months after intervention. Method of measurement: bioimpedance analysis.</sec_outcome>
      <sec_outcome>Lean mass. Timepoint: before intervention, 6 and 12 months after intervention. Method of measurement: bioimpedance analysis.</sec_outcome>
      <sec_outcome>Systolic and diastolic blood pressure. Timepoint: before intervention, 6 and 12 months after intervention. Method of measurement: Sphygmomanometer.</sec_outcome>
      <sec_outcome>Calcium. Timepoint: before intervention, 6 and 12 months after intervention. Method of measurement: colorimetry.</sec_outcome>
      <sec_outcome>Phosphorus. Timepoint: before intervention, 6 and 12 months after intervention. Method of measurement: colorimetry.</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>Institute for Endocrine Science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-07-19</approval_date>
        <contact_name>institutional ethics committee of the Research Institute for Endocrine Sciences, affiliated to the S</contact_name>
        <contact_address>No.24, Parvaneh Ave., Yaman str., Velenjak Blvd., Chamran High way Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
