Autism Spectrum DisorderCREATORNCT04498078
Creatine Supplementation in Autism Spectrum Disorder
A study testing Creatine in people with Autism Spectrum Disorder, run by University of Novi Sad, Faculty of Sport and Physical Education at 1 site in Serbia.
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… Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Creatine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSerbia
- Study dates
- 15 Jan 2022to 2 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Pregnant or nursing female patients
- Non-pharmacologic therapy
- Current diagnosis of other mental disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Creatine
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CreatineDietary supplement
Creatine monohydrate (20 g per day)
| Study group | Role | What they receive |
|---|---|---|
| Creatine | Experimental | Twenty grams per day b.i.d. Receives: Dietary Supplement: Creatine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain creatine change
Monitor change in brain creatine levels by magnetic resonance imaging
Measured: Change from Baseline Brain Creatine Levels at 6 Months
Secondary outcomes (2)
Brain N-acetylaspartate change
Monitor change in brain N-acetylaspartate levels by magnetic resonance imaging
Measured: Change from Baseline Brain N-acetylaspartate Levels at 6 Months
Autism Treatment Evaluation Checklist (ATEC) score
Monitor changes in ASD severity
Measured: Change from Baseline ATEC Scores at 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2020
- Study start15 Jan 2022
- Primary completion1 May 2025
- Study completion2 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Novi Sad, Faculty of Sport and Physical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sergej Ostojic, MD, PhD, Study chair, Applied Bioenergetics Lab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04498078
- Sponsor's protocol ID
- ABL-21-AUCR
- Acronym
- CREATOR
- Status last verified
- Dec 2025
- First submitted
- 27 Jul 2020
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized data will be provide via institutional online depository
Publications
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.
PubMed 31909886
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Creatine Supplementation in Autism Spectrum Disorder: a Randomized Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT04498078
- Acronym / sponsor ID
- CREATOR / ABL-21-AUCR
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Novi Sad, Faculty of Sport and Physical EducationUniversity, hospital or other
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 2 May 2025 (actual)
- First posted
- 4 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Creatine | Experimental | Dietary Supplement: CreatineTwenty grams per day b.i.d. |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Pregnant or nursing female patients
- Non-pharmacologic therapy
- Current diagnosis of other mental disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CreatineCreatine monohydrate (20 g per day) | Dietary supplement | Creatine |
Primary outcome
Brain creatine change
Time frame: Change from Baseline Brain Creatine Levels at 6 Months
Monitor change in brain creatine levels by magnetic resonance imaging
2 secondary outcomes
Brain N-acetylaspartate change
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Background: PubMed 31909886Edmondson 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.
- Individual participant dataSharing planned: Yes. Anonymized data will be provide via institutional online depository
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sergej Ostojic, MD, PhD study chair
Applied Bioenergetics Lab
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Creatine in people with Autism Spectrum Disorder, run by University of Novi Sad, Faculty of Sport and Physical Education at 1 site in Serbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain creatine change (time frame: Change from Baseline Brain Creatine Levels at 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04498078, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.