Creatine Supplementation in Autism Spectrum Disorder

Autism Spectrum Disorder Clinical Trial

— CREATOR  

Official title:

The Effects of Creatine Supplementation in Autism Spectrum Disorder: a Randomized Placebo-controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04498078
• Other study ID #: ABL-21-AUCR
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 15, 2022
• Est. completion date: February 14, 2025

Study information

• Verified date: February 2024
• Source: University of Novi Sad, Faculty of Sport and Physical Education
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: February 14, 2025
• Est. primary completion date: January 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive

Intervention

Dietary Supplement:
• Creatine
Creatine monohydrate (20 g per day)

Locations

Country	Name	City	State
Serbia	FSPE Applied Bioenergetics Lab	Novi Sad	Vojvodina

Sponsors (1)

Lead Sponsor	Collaborator
University of Novi Sad, Faculty of Sport and Physical Education

Country where clinical trial is conducted

Serbia, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants With Potentially Clinically Relevant Laboratory Metabolic Abnormalities	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	Number of Participants With Potentially Clinically Relevant Laboratory Metabolic Abnormalities at 6-Month Follow-up
Other	Maximal oxygen uptake change	Monitor changes in maximal oxygen uptake during an incremental exercise test on a treadmill	Change from Baseline Cardiorespiratory Capacity at 6 Months
Primary	Brain creatine change	Monitor change in brain creatine levels by magnetic resonance imaging	Change from Baseline Brain Creatine Levels at 6 Months
Secondary	Brain N-acetylaspartate change	Monitor change in brain N-acetylaspartate levels by magnetic resonance imaging	Change from Baseline Brain N-acetylaspartate Levels at 6 Months
Secondary	Autism Treatment Evaluation Checklist (ATEC) score	Monitor changes in ASD severity	Change from Baseline ATEC Scores at 6 Months