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NCT Number: NCT07365553

Omega-3, Autism Spectrum Disorder (ASD)

This is a 12 week study to investigate the effects of omega-3 polyunsaturated fatty acids (PUFAs) in youth with autism spectrum disorder (ASD).

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Key information

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

China Medical University

Taichung, 404, Taiwan

Location status: Recruiting

Location contact

Pei-Chen Chang, MD, PHD

CONTACT

[email protected]

886 4 22052121

Pei-Chen Chang, MD, PhD

PRINCIPAL_INVESTIGATOR

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Omega-3

Dietary Supplement

Omega-3 PUFAs

Placebo

Dietary Supplement

Soybean Oil

Primary outcomes

  1. Clinical Symptoms-Behavioral problems (Aberrant Behavior Checklist, ABC)

    Time frame: Baseline, week 1,2,4,8,12

    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

Secondary outcomes

  1. Concentration of blood inflammatory biomarkers in pg/mL

    Time frame: Baseline and week 12

    Interleukin (IL)-1 beta (picogram/milliliter, pg/ML) IL-6 IL-10 Tumor necrosis factor -αlpha Interferon (IFN)-γ

  2. Cognitive function-attention and impulsivity (Continuous Performance Test, CPT)

    Time frame: Baseline and week 12

    CPT will be used to measure the attention and impulsivity in the subjects.

  3. Clinical symptoms: Behavioral problems (Strength and Difficulty Questionnaire, SDQ)

    Time frame: Baseline and week 12

    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.

  4. Stool Sample

    Time frame: Baseline and week 12

    Gut microbiomal sequencing, Faecal short-chain fatty acids

  5. Heart Rate variability (HRV)

    Time frame: Baseline and week 12

    Autonomic nervous function (ANS) will be assessed with HRV.

  6. Concentration of blood high-sensitivity C-reactive Protein (hs-CRP)

    Time frame: Baseline and week 12

    measurement of peripheral blood hs-CRP units in milligram/Liter (mg/L)

  7. Concentration of Red Blood Cell (RBC) Polyunsaturated Fatty Acids (PUFAs)

    Time frame: Baseline and week 12

    Measurement of RBC PUFAs units in %

  8. Cognitive function: memory (Wechsler Memory Scale, WMS)

    Time frame: Baseline and week 12

    WMS will be used to measure memory function of the subjects.

  9. Clinical symptoms: attention and hyperactivity (Swanson, Nolan, and Pelham Rating Scale - Version IV, SNAP-IV)

    Time frame: Baseline and week 12

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Pei-Chen Chang, MD, PhD

CONTACT

[email protected]

0422052121 ext. 4126

Sponsors and collaborators

Lead sponsor

China Medical University Hospital

Other

Registry information

Official study 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

Acronym: OMeASD

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jan 26, 2026
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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