<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04498078</url>
  </required_header>
  <id_info>
    <org_study_id>ABL-21-AUCR</org_study_id>
    <nct_id>NCT04498078</nct_id>
  </id_info>
  <brief_title>Creatine Supplementation in Autism Spectrum Disorder</brief_title>
  <acronym>CREATOR</acronym>
  <official_title>The Effects of Creatine Supplementation in Autism Spectrum Disorder: a Randomized Placebo-controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Novi Sad, Faculty of Sport and Physical Education</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Novi Sad, Faculty of Sport and Physical Education</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Autism Spectrum Disorder (ASD) is accompanied by reduced levels of total creatine in right&#xD;
      temporal-parietal junction and other brain regions of interest, and addressing this deficit&#xD;
      by exogenous administration of creatine may have beneficial effects on brain metabolism and&#xD;
      disease-specific clinical symptoms in patients suffering from ASD.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 15, 2022</start_date>
  <completion_date type="Anticipated">February 14, 2024</completion_date>
  <primary_completion_date type="Anticipated">January 15, 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Brain creatine change</measure>
    <time_frame>Change from Baseline Brain Creatine Levels at 6 Months</time_frame>
    <description>Monitor change in brain creatine levels by magnetic resonance imaging</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Brain N-acetylaspartate change</measure>
    <time_frame>Change from Baseline Brain N-acetylaspartate Levels at 6 Months</time_frame>
    <description>Monitor change in brain N-acetylaspartate levels by magnetic resonance imaging</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Autism Treatment Evaluation Checklist (ATEC) score</measure>
    <time_frame>Change from Baseline ATEC Scores at 6 Months</time_frame>
    <description>Monitor changes in ASD severity</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of Participants With Potentially Clinically Relevant Laboratory Metabolic Abnormalities</measure>
    <time_frame>Number of Participants With Potentially Clinically Relevant Laboratory Metabolic Abnormalities at 6-Month Follow-up</time_frame>
    <description>Abnormal metabolic criterion values include fasting serum aspartate aminotransferase ≥ 40 U/L, fasting serum alanine aminotransferase ≥ 56 U/L, fasting serum gamma-glutamyl transferase ≥ 48 U/L</description>
  </other_outcome>
  <other_outcome>
    <measure>Maximal oxygen uptake change</measure>
    <time_frame>Change from Baseline Cardiorespiratory Capacity at 6 Months</time_frame>
    <description>Monitor changes in maximal oxygen uptake during an incremental exercise test on a treadmill</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Autism Spectrum Disorder</condition>
  <arm_group>
    <arm_group_label>Creatine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Twenty grams per day b.i.d.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Creatine</intervention_name>
    <description>Creatine monohydrate (20 g per day)</description>
    <arm_group_label>Creatine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 10 years and above&#xD;
&#xD;
          -  Informed consent signed by a parent or legal guardian or legal representative&#xD;
&#xD;
          -  Diagnostic and Statistical Manual of Mental Disorders-IV criteria for ASD.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or nursing female patients&#xD;
&#xD;
          -  Non-pharmacologic therapy&#xD;
&#xD;
          -  Current diagnosis of other mental disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nebojsa Maksimovic, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Faculty of Sport and PE</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>FSPE Applied Bioenergetics Lab</name>
      <address>
        <city>Novi Sad</city>
        <state>Vojvodina</state>
        <zip>21000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Serbia</country>
  </location_countries>
  <reference>
    <citation>Edmondson DA, Xia P, McNally Keehn R, Dydak U, Keehn B. A Magnetic Resonance Spectroscopy Study of Superior Visual Search Abilities in Children with Autism Spectrum Disorder. Autism Res. 2020 Apr;13(4):550-562. doi: 10.1002/aur.2258. Epub 2020 Jan 7.</citation>
    <PMID>31909886</PMID>
  </reference>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>July 27, 2020</study_first_submitted>
  <study_first_submitted_qc>July 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>May 8, 2023</last_update_submitted>
  <last_update_submitted_qc>May 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Autistic Disorder</mesh_term>
    <mesh_term>Autism Spectrum Disorder</mesh_term>
    <mesh_term>Child Development Disorders, Pervasive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Anonymized data will be provide via institutional online depository</ipd_description>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>From January 2022 to December 2022</ipd_time_frame>
    <ipd_access_criteria>Free access</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04498078
org study id: ABL-21-AUCR
nct id: NCT04498078
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Autism Spectrum Disorder (ASD) is accompanied by reduced levels of total creatine in right
      temporal-parietal junction and other brain regions of interest, and addressing this deficit
      by exogenous administration of creatine may have beneficial effects on brain metabolism and
      disease-specific clinical symptoms in patients suffering from ASD.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Brain creatine change
time frame: Change from Baseline Brain Creatine Levels at 6 Months
description: Monitor change in brain creatine levels by magnetic resonance imaging
measure: Brain N-acetylaspartate change
time frame: Change from Baseline Brain N-acetylaspartate Levels at 6 Months
description: Monitor change in brain N-acetylaspartate levels by magnetic resonance imaging
measure: Autism Treatment Evaluation Checklist (ATEC) score
time frame: Change from Baseline ATEC Scores at 6 Months
description: Monitor changes in ASD severity
measure: Number of Participants With Potentially Clinically Relevant Laboratory Metabolic Abnormalities
time frame: Number of Participants With Potentially Clinically Relevant Laboratory Metabolic Abnormalities at 6-Month Follow-up
description: Abnormal metabolic criterion values include fasting serum aspartate aminotransferase ≥ 40 U/L, fasting serum alanine aminotransferase ≥ 56 U/L, fasting serum gamma-glutamyl transferase ≥ 48 U/L
measure: Maximal oxygen uptake change
time frame: Change from Baseline Cardiorespiratory Capacity at 6 Months
description: Monitor changes in maximal oxygen uptake during an incremental exercise test on a treadmill
arm group label: Creatine
arm group type: Experimental
description: Twenty grams per day b.i.d.
intervention type: Dietary Supplement
intervention name: Creatine
description: Creatine monohydrate (20 g per day)
arm group label: Creatine
criteria: 
gender: All
minimum age: 10 Years
maximum age: N/A
healthy volunteers: No
last name: Nebojsa Maksimovic, PhD
role: Study Chair
affiliation: Faculty of Sport and PE
facility: 
country: Serbia
citation: Edmondson DA, Xia P, McNally Keehn R, Dydak U, Keehn B. A Magnetic Resonance Spectroscopy Study of Superior Visual Search Abilities in Children with Autism Spectrum Disorder. Autism Res. 2020 Apr;13(4):550-562. doi: 10.1002/aur.2258. Epub 2020 Jan 7.
PMID: 31909886
responsible party type: Sponsor
mesh term: Autistic Disorder
mesh term: Autism Spectrum Disorder
mesh term: Child Development Disorders, Pervasive
sharing ipd: Yes
ipd description: Anonymized data will be provide via institutional online depository
ipd info type: Clinical Study Report (CSR)
ipd time frame: From January 2022 to December 2022
ipd access criteria: Free access