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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Creatine | Experimental | Twenty grams per day b.i.d. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Creatine | Dietary Supplement | Creatine monohydrate (20 g per day) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Brain creatine change | Monitor change in brain creatine levels by magnetic resonance imaging | Change from Baseline Brain Creatine Levels at 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Autism Treatment Evaluation Checklist (ATEC) score |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sergej Ostojic, MD, PhD | Applied Bioenergetics Lab | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| FSPE Applied Bioenergetics Lab | Novi Sad | Vojvodina | 21000 | Serbia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31909886 | Background | 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. |
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Anonymized data will be provide via institutional online depository
From January 2022 to December 2022
Free access
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D003401 | Creatine |
| ID | Term |
|---|---|
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
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Monitor changes in ASD severity
| Change from Baseline ATEC Scores at 6 Months |
| 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 |
| D000602 |
| Amino Acids, Peptides, and Proteins |