Omega-3, Autism Spectrum Disorder (ASD)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Omega-3, Placebo.
- Who it may be relevant to
- Registry conditions: ASD. Basic parameters: 6 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Omega-3 Fatty Acids and Autism Spectrum Disorder (ASD) - A Double-blind Randomized Controlled Trial of Omega-3 Fatty Acids in Youth With ASD
Overview
This is a 12 week study to investigate the effects of omega-3 polyunsaturated fatty acids (PUFAs) in youth with autism spectrum disorder (ASD).
Detailed description
This is a 12 week study to investigate the effects of omega-3 PUFAs in children (6-17 years-old) with ASD.
The primary outcome will be the clinical symptoms rated by the Aberrant Behavior Checklist (ABC). The secondary outcomes will be inflammatory biomarkers, cognitive function and physiological markers such as heart-rate variability (HRV).
Interventions
- Dietary supplement Omega-3
Omega-3 PUFAs - Dietary supplement Placebo
Soybean Oil
Primary outcome measures
- Clinical Symptoms-Behavioral problems (Aberrant Behavior Checklist, ABC) [Time frame: Baseline, week 1,2,4,8,12]
Secondary outcome measures (9)
- Concentration of blood inflammatory biomarkers in pg/mL [Time frame: Baseline and week 12]
- Cognitive function-attention and impulsivity (Continuous Performance Test, CPT) [Time frame: Baseline and week 12]
- Clinical symptoms: Behavioral problems (Strength and Difficulty Questionnaire, SDQ) [Time frame: Baseline and week 12]
- Stool Sample [Time frame: Baseline and week 12]
- Heart Rate variability (HRV) [Time frame: Baseline and week 12]
- Concentration of blood high-sensitivity C-reactive Protein (hs-CRP) [Time frame: Baseline and week 12]
- Concentration of Red Blood Cell (RBC) Polyunsaturated Fatty Acids (PUFAs) [Time frame: Baseline and week 12]
- Cognitive function: memory (Wechsler Memory Scale, WMS) [Time frame: Baseline and week 12]
- Clinical symptoms: attention and hyperactivity (Swanson, Nolan, and Pelham Rating Scale - Version IV, SNAP-IV) [Time frame: Baseline and week 12]
Eligibility criteria
Inclusion criteria
- diagnosis of DSM5 ASD made by child and adolescent psychiatrist
- age 6-17 years-old at the time of enrolment
- no pharmacotherapy or non-pharmacotherapy adjustment within the past 4 weeks,
- Signed informed consent.
Exclusion criteria
- comorbid other psychiatric disorders, including schizophrenia or affective mood disorder (Bipolar and Major Depressive Disorder), or substance use disorder
- comorbid physical disorders, such as thyroid dysfunction, cerebral palsy, coagulation disorders
- currently using omega-3 supplements or probiotics
- allergy to omega-3.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Taiwan · 1 center
- China Medical University — Taichung
Identifiers
NCT: NCT07365553 · CMUH110-REC3-113