Back to resultsCreatine Supplementation in Autism Spectrum Disorder (CREATOR)
Primary Purpose
Autism Spectrum Disorder
Status
Active
Phase
Not Applicable
Locations
Serbia
Study Type
Interventional
Intervention
Creatine
Sponsored by
About this trial
This is an interventional supportive care trial for Autism Spectrum Disorder
Eligibility Criteria
Inclusion Criteria:
- Age 10 years and above
- Informed consent signed by a parent or legal guardian or legal representative
- Diagnostic and Statistical Manual of Mental Disorders-IV criteria for ASD.
Exclusion Criteria:
- Pregnant or nursing female patients
- Non-pharmacologic therapy
- Current diagnosis of other mental disorder
Sites / Locations
- FSPE Applied Bioenergetics Lab
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Creatine
Arm Description
Twenty grams per day b.i.d.
Outcomes
Primary Outcome Measures
Brain creatine change
Monitor change in brain creatine levels by magnetic resonance imaging
Secondary Outcome Measures
Brain N-acetylaspartate change
Monitor change in brain N-acetylaspartate levels by magnetic resonance imaging
Autism Treatment Evaluation Checklist (ATEC) score
Monitor changes in ASD severity
Full Information
NCT ID
NCT04498078
First Posted
July 27, 2020
Last Updated
May 8, 2023
Sponsor
University of Novi Sad, Faculty of Sport and Physical Education
1. Study Identification
Unique Protocol Identification Number
NCT04498078
Brief Title
Creatine Supplementation in Autism Spectrum Disorder
Acronym
CREATOR
Official Title
The Effects of Creatine Supplementation in Autism Spectrum Disorder: a Randomized Placebo-controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 15, 2022 (Actual)
Primary Completion Date
January 15, 2024 (Anticipated)
Study Completion Date
February 14, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Novi Sad, Faculty of Sport and Physical Education
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Creatine
Arm Type
Experimental
Arm Description
Twenty grams per day b.i.d.
Intervention Type
Dietary Supplement
Intervention Name(s)
Creatine
Intervention Description
Creatine monohydrate (20 g per day)
Primary Outcome Measure Information:
Title
Brain creatine change
Description
Monitor change in brain creatine levels by magnetic resonance imaging
Time Frame
Change from Baseline Brain Creatine Levels at 6 Months
Secondary Outcome Measure Information:
Title
Brain N-acetylaspartate change
Description
Monitor change in brain N-acetylaspartate levels by magnetic resonance imaging
Time Frame
Change from Baseline Brain N-acetylaspartate Levels at 6 Months
Title
Autism Treatment Evaluation Checklist (ATEC) score
Description
Monitor changes in ASD severity
Time Frame
Change from Baseline ATEC Scores at 6 Months
Other Pre-specified Outcome Measures:
Title
Number of Participants With Potentially Clinically Relevant Laboratory Metabolic Abnormalities
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
Time Frame
Number of Participants With Potentially Clinically Relevant Laboratory Metabolic Abnormalities at 6-Month Follow-up
Title
Maximal oxygen uptake change
Description
Monitor changes in maximal oxygen uptake during an incremental exercise test on a treadmill
Time Frame
Change from Baseline Cardiorespiratory Capacity at 6 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 10 years and above
Informed consent signed by a parent or legal guardian or legal representative
Diagnostic and Statistical Manual of Mental Disorders-IV criteria for ASD.
Exclusion Criteria:
Pregnant or nursing female patients
Non-pharmacologic therapy
Current diagnosis of other mental disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nebojsa Maksimovic, PhD
Organizational Affiliation
Faculty of Sport and PE
Official's Role
Study Chair
Facility Information:
Facility Name
FSPE Applied Bioenergetics Lab
City
Novi Sad
State/Province
Vojvodina
ZIP/Postal Code
21000
Country
Serbia
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized data will be provide via institutional online depository
IPD Sharing Time Frame
From January 2022 to December 2022
IPD Sharing Access Criteria
Free access
Citations:
PubMed Identifier
31909886
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.
Results Reference
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Creatine Supplementation in Autism Spectrum Disorder
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