Autism Spectrum Disorder
Conditions
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.
Interventions
DIETARY_SUPPLEMENTCreatine
Creatine monohydrate (20 g per day)
Sponsors
University of Novi Sad, Faculty of Sport and Physical Education
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brain creatine change | Change from Baseline Brain Creatine Levels at 6 Months | Monitor change in brain creatine levels by magnetic resonance imaging |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Brain N-acetylaspartate change | Change from Baseline Brain N-acetylaspartate Levels at 6 Months | Monitor change in brain N-acetylaspartate levels by magnetic resonance imaging |
| Autism Treatment Evaluation Checklist (ATEC) score | Change from Baseline ATEC Scores at 6 Months | Monitor changes in ASD severity |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 |
| Maximal oxygen uptake change | Change from Baseline Cardiorespiratory Capacity at 6 Months | Monitor changes in maximal oxygen uptake during an incremental exercise test on a treadmill |
Countries
Serbia
Outcome results
None listed