Creatine Supplementation in Autism Spectrum Disorder (CREATOR)

February 5, 2024 updated by: University of Novi Sad, Faculty of Sport and Physical Education

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Serbia
    • Vojvodina
      • Novi Sad, Vojvodina, Serbia, 21000
        • FSPE Applied Bioenergetics Lab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Creatine
Twenty grams per day b.i.d.
Dietary supplement: Creatine
Creatine monohydrate (20 g per day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brain creatine change
Time Frame: Change from Baseline Brain Creatine Levels at 6 Months
Monitor change in brain creatine levels by magnetic resonance imaging
Change from Baseline Brain Creatine Levels at 6 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change from Baseline Brain N-acetylaspartate Levels at 6 Months
Autism Treatment Evaluation Checklist (ATEC) score
Time Frame: Change from Baseline ATEC Scores at 6 Months
Monitor changes in ASD severity
Change from Baseline ATEC Scores at 6 Months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Number of Participants With Potentially Clinically Relevant Laboratory Metabolic Abnormalities at 6-Month Follow-up
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
Change from Baseline Cardiorespiratory Capacity at 6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Novi Sad, Faculty of Sport and Physical Education

Investigators

  • Study Chair: Nebojsa Maksimovic, PhD, Faculty of Sport and PE

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2022

Primary Completion (Estimated)

January 15, 2025

Study Completion (Estimated)

February 14, 2025

Study Registration Dates

First Submitted

July 27, 2020

First Submitted That Met QC Criteria

July 30, 2020

First Posted (Actual)

August 4, 2020

Study Record Updates

Last Update Posted (Actual)

February 6, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABL-21-AUCR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Autism Spectrum Disorder

Clinical Trials on Creatine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Thailand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe