Creatine Supplementation in Autism Spectrum Disorder

NCT04498078 | Completed

• 1 other identifier: ABL-21-AUCR
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

• Brain creatine change

  Monitor change in brain creatine levels by magnetic resonance imaging

  Change from Baseline Brain Creatine Levels at 6 Months

Secondary Outcomes (2)

• Brain N-acetylaspartate change

  Change from Baseline Brain N-acetylaspartate Levels at 6 Months

• Autism Treatment Evaluation Checklist (ATEC) score

  Change from Baseline ATEC Scores at 6 Months

Other Outcomes (2)

• Number of Participants With Potentially Clinically Relevant Laboratory Metabolic Abnormalities

  Number of Participants With Potentially Clinically Relevant Laboratory Metabolic Abnormalities at 6-Month Follow-up

• Maximal oxygen uptake change

  Change from Baseline Cardiorespiratory Capacity at 6 Months

Study Arms (1)

Creatine

EXPERIMENTAL

Twenty grams per day b.i.d.

Dietary Supplement: Creatine

Interventions

Creatine DIETARY_SUPPLEMENT

Creatine monohydrate (20 g per day)

Creatine

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pregnant or nursing female patients
• Non-pharmacologic therapy
• Current diagnosis of other mental disorder

Sponsors & Collaborators

• University of Novi Sad, Faculty of Sport and Physical Education: lead

Study Sites (1)

FSPE Applied Bioenergetics Lab

Novi Sad, Vojvodina, 21000, Serbia

Location

Related 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.

  PMID: 31909886 BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Creatine

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Sergej Ostojic, MD, PhD

  Applied Bioenergetics Lab

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2020
• First Posted: August 4, 2020
• Study Start: January 15, 2022
• Primary Completion: May 1, 2025
• Study Completion: May 2, 2025
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: From January 2022 to December 2022
• Access Criteria: Free access

Locations

SE (1)