Creatine Supplementation in Autism Spectrum Disorder
Not Applicable
Active, not recruiting
- Conditions
- Autism Spectrum Disorder
- Interventions
- Dietary Supplement: Creatine
- Registration Number
- NCT04498078
- Lead Sponsor
- University of Novi Sad, Faculty of Sport and Physical Education
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 20
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Creatine Creatine Twenty grams per day b.i.d.
- Primary Outcome Measures
Name Time Method Brain creatine change Change from Baseline Brain Creatine Levels at 6 Months Monitor change in brain creatine levels by magnetic resonance imaging
- Secondary Outcome Measures
Name Time Method Autism Treatment Evaluation Checklist (ATEC) score Change from Baseline ATEC Scores at 6 Months Monitor changes in ASD severity
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
Trial Locations
- Locations (1)
FSPE Applied Bioenergetics Lab
🇷🇸Novi Sad, Vojvodina, Serbia