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OpenTrials
Completed

NCT Number: NCT04498078

Creatine Supplementation in Autism Spectrum Disorder

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.

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Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

10 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

FSPE Applied Bioenergetics Lab

Novi Sad, Vojvodina, 21000, Serbia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Creatine

Dietary Supplement

Creatine monohydrate (20 g per day)

Primary outcomes

  1. Brain creatine change

    Time frame: Change from Baseline Brain Creatine Levels at 6 Months

    Monitor change in brain creatine levels by magnetic resonance imaging

Secondary outcomes

  1. Brain N-acetylaspartate change

    Time frame: Change from Baseline Brain N-acetylaspartate Levels at 6 Months

    Monitor change in brain N-acetylaspartate levels by magnetic resonance imaging

  2. Autism Treatment Evaluation Checklist (ATEC) score

    Time frame: Change from Baseline ATEC Scores at 6 Months

    Monitor changes in ASD severity

Other outcomes

  1. 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

    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

  2. Maximal oxygen uptake change

    Time frame: Change from Baseline Cardiorespiratory Capacity at 6 Months

    Monitor changes in maximal oxygen uptake during an incremental exercise test on a treadmill

Sponsors and collaborators

Lead sponsor

University of Novi Sad, Faculty of Sport and Physical Education

Other

Registry information

Official study title

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

Acronym: CREATOR

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Aug 4, 2020
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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