An interventional study of Omega-3 and Placebo in ASD, sponsored by China Medical University Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-01-26.
Sponsored by China Medical University Hospital · Not applicable, Interventional, and Treatment
This is a 12 week study to investigate the effects of omega-3 polyunsaturated fatty acids (PUFAs) in youth with autism spectrum disorder (ASD).
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).
3,439 studies on the registry are indexed under Inflammation; 629 are open to participants now.
This study's planned enrollment of 50 is close to the median of 50 across 2,437 interventional studies indexed under Inflammation.
Browse Inflammation studies →China Medical University Hospital is the lead sponsor of 464 studies on the registry; 116 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
EPA
Dietary Supplement: Omega-3
Soybean Oil
Dietary Supplement: Placebo
DHA
Dietary Supplement: Omega-3
Omega-3 PUFAs
Soybean Oil
Clinical Symptoms-Behavioral problems (Aberrant Behavior Checklist, ABC)
The ABC will be used to assess the behavioral problems of participants. It consists of 58 items that describe various behaviors, such as aggression or hyperactivity, and is typically completed by a caregiver or teacher who knows the individual well. Each item is rated on a 4-point scale: 0 = not at all a problem, 1 = slight problem, 2 = moderate problem, and 3 = severe problem. Scores are summed across all items to produce a total score ranging from 0 to 174, with higher scores indicating more severe or frequent problem behaviors
Time frame: Baseline, week 1,2,4,8,12
Concentration of blood inflammatory biomarkers in pg/mL
Interleukin (IL)-1 beta (picogram/milliliter, pg/ML) IL-6 IL-10 Tumor necrosis factor -αlpha Interferon (IFN)-γ
Time frame: Baseline and week 12
Cognitive function-attention and impulsivity (Continuous Performance Test, CPT)
CPT will be used to measure the attention and impulsivity in the subjects.
Time frame: Baseline and week 12
Clinical symptoms: Behavioral problems (Strength and Difficulty Questionnaire, SDQ)
SDQ will be used to assess behavior problems of the participants. SDQ is a brief behavioral screening tool for children and adolescents, typically aged 3-16, designed to assess emotional and behavioral difficulties as well as prosocial strengths. It has 25 items divided into five subscales: Emotional Symptoms, Conduct Problems, Hyperactivity/Inattention, Peer Problems, and Prosocial Behavior, with each subscale containing 5 items. Items are rated on a 3-point scale: 0 = "Not True," 1 = "Somewhat True," 2 = "Certainly True." Scoring involves summing the first four subscales to calculate a Total Difficulties Score (range 0-40), while the Prosocial subscale is scored separately (range 0-10) as a measure of strengths. Higher Total Difficulties Scores indicate greater behavioral or emotional problems, while higher Prosocial scores indicate stronger social skills.
Time frame: Baseline and week 12
Stool Sample
Gut microbiomal sequencing, Faecal short-chain fatty acids
Time frame: Baseline and week 12
Heart Rate variability (HRV)
Autonomic nervous function (ANS) will be assessed with HRV.
Time frame: Baseline and week 12
Concentration of blood high-sensitivity C-reactive Protein (hs-CRP)
measurement of peripheral blood hs-CRP units in milligram/Liter (mg/L)
Time frame: Baseline and week 12
Concentration of Red Blood Cell (RBC) Polyunsaturated Fatty Acids (PUFAs)
Measurement of RBC PUFAs units in %
Time frame: Baseline and week 12
Cognitive function: memory (Wechsler Memory Scale, WMS)
WMS will be used to measure memory function of the subjects.
Time frame: Baseline and week 12
Clinical symptoms: attention and hyperactivity (Swanson, Nolan, and Pelham Rating Scale - Version IV, SNAP-IV)
The SNAP-IV is used to assess attention, hyperactivity and oppositional defiant disorder symptoms in the subjects. It contains 26 items rated on a 4-point scale from 0 ("Not at all") to 3 ("Very much"), reflecting the frequency or severity of each behavior. The items are grouped into three subscales: Inattention, Hyperactivity/Impulsivity, and Oppositional Defiant behaviors, with scores summed within each subscale. Higher scores indicate more severe symptoms, and the scale can be completed by parents, teachers, or clinicians to provide a reliable measure for both clinical evaluation and research.
Time frame: Baseline and week 12
Plan to share: No
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China Medical University Hospital