<?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>IRCT20150519022323N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-12-16</date_registration>
      <primary_sponsor>Ferdowsi University Of Mashhad, Mashhad</primary_sponsor>
      <public_title>The effect of Perceptual motor Exercises along with music and Vitamin D3 Supplementation in children with autism spectrum disorder</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Perceptual-motor Exercises along with music and Vitamin D3 Supplementation on Nerve Growth Factor, Attention, motor proficiency and GARS-2 in children with high-functioning autism</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-11-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>150</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/19275</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The children with autism spectrum disorders were randomly selected from the Autism Center. Then, They were randomly assigned to one of the four study groups and receive the special intervention.</study_design>
      <phase>2</phase>
      <hc_freetext>autism.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: The protocol of Perceptual-motor Exercises along with music was 36 sessions at 12 weeks (3 months) and three sessions per week, with each session lasting 60 minutes. They included stretching and jogging (10 minutes), main perceptual-motor exercises (45 minutes), and cool down (5 minutes). Intervention 2: Intervention group 2: The intervention related to the group 2 includes intake of Vitamin D tablets (300 IU/ day not to exceed 5,000 IU/day). Intervention 3: Intervention group 3: In Group 3, both interventions of Groups 1 and 2 were conducted for 3 months (Perceptual-motor Exercises along with music was 36 sessions (3 months) + receive vitamin D3 drops, 300 IU/ day not to exceed 5,000 IU/day for 3 months). Intervention 4: Control group: Children with ASD in Group 4 also received placebos during the investigation period. The placebo consisted of a combination of polysorbate 20, which is the same fragrance ingredient used in vitamin D drops in addition to glycerin, disodium edetate, and b-cyclodextrin in purified water.</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></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hadi Moradi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ferdowsi University Of Mashhad, Azadi</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>88717-96545</zip>
        <telephone>+98 38 3422 8893</telephone>
        <email>hadi.moradi@stu.um.ac.ir</email>
        <affiliation>Ferdowsi University Of Mashhad</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hadi Moradi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ferdowsi University Of Mashhad, Azadi</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8871796545</zip>
        <telephone>+98 38 3422 8893</telephone>
        <email>hadi.moradi@stu.um.ac.ir</email>
        <affiliation>Ferdowsi University Of Mashhad</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>An autism diagnosis confirmed by a psychologist along with a medical team and based on diagnostic criteria DSM-5
Children with high-functioning autism disorder
Vitamin D serum level less than 30 ng/ml
Chronological age between six and nine years
IQ more than 70
Sound sense of sight and hearing
Obtaining consent from parents</inclusion_criteria>
      <agemin>6 years</agemin>
      <agemax>9 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Children with autoimmune disorders
Subjects who had associated gastrointestinal problems
Children with neurological diseases
Children with malnutrition
Children with anemia
Children with orthopedic and respiratory disorders
Seizure attacks in the last two years</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F84.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Childhood autism</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: The protocol of Perceptual-motor Exercises along with music was 36 sessions at 12 weeks (3 months) and three sessions per week, with each session lasting 60 minutes. They included stretching and jogging (10 minutes), main perceptual-motor exercises (45 minutes), and cool down (5 minutes).</i_keyword>
      <i_keyword>Intervention group 2: The intervention related to the group 2 includes intake of Vitamin D tablets (300 IU/ day not to exceed 5,000 IU/day).</i_keyword>
      <i_keyword>Intervention group 3: In Group 3, both interventions of Groups 1 and 2 were conducted for 3 months (Perceptual-motor Exercises along with music was 36 sessions (3 months) + receive vitamin D3 drops, 300 IU/ day not to exceed 5,000 IU/day for 3 months).</i_keyword>
      <i_keyword>Control group: Children with ASD in Group 4 also received placebos during the investigation period. The placebo consisted of a combination of polysorbate 20, which is the same fragrance ingredient used in vitamin D drops in addition to glycerin, disodium edetate, and b-cyclodextrin in purified water.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Nerve Growth Factor. Timepoint: Before Intervention, 12 Weeks After Intervention. Method of measurement: The research kit of the Nerve Growth Factor.</prim_outcome>
      <prim_outcome>Attention. Timepoint: Before Intervention, 12 Weeks After Intervention. Method of measurement: Stroop test.</prim_outcome>
      <prim_outcome>Motor proficiency. Timepoint: Before Intervention, 12 Weeks After Intervention. Method of measurement: Bruininks-Oseretsky Test of Motor Proficiency.</prim_outcome>
      <prim_outcome>Stereotypic behaviors. Timepoint: Before Intervention, 12 Weeks After Intervention. Method of measurement: Gilliam Autism Rating Scale-Second Edition (GARS-2).</prim_outcome>
      <prim_outcome>Communication. Timepoint: Before Intervention, 12 Weeks After Intervention. Method of measurement: Gilliam Autism Rating Scale-Second Edition (GARS-2).</prim_outcome>
      <prim_outcome>Social. Timepoint: Before Intervention, 12 Weeks After Intervention. Method of measurement: Gilliam Autism Rating Scale-Second Edition (GARS-2).</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>Ferdowsi University Of Mashhad, Mashhad</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-05-22</approval_date>
        <contact_name>Ethics committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Mashhad University Of Medical Sciences, Azadi Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
