Omega-3, Autism Spectrum Disorder (ASD) (OMeASD)

January 16, 2026 updated by: Pei-Chen Chang, China Medical University Hospital

Omega-3 Fatty Acids and Autism Spectrum Disorder (ASD) - A Double-blind Randomized Controlled Trial of Omega-3 Fatty Acids in Youth With 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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Taiwan
    • Taichung
      • Taichung, Taichung, Taiwan, 404
        • Recruiting
        • China Medical University
        • Contact:
        • Principal Investigator:
          • Pei-Chen Chang, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Omega-3 (EPA)
EPA
Dietary supplement: Omega-3
Omega-3 PUFAs
Placebo Comparator: Placebo
Soybean Oil
Dietary supplement: Placebo
Soybean Oil
Experimental: Omega-3 (DHA)
DHA
Dietary supplement: Omega-3
Omega-3 PUFAs

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Baseline, week 1,2,4,8,12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Baseline and week 12
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.
Baseline and week 12
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.
Baseline and week 12
Stool Sample
Time Frame: Baseline and week 12
Gut microbiomal sequencing, Faecal short-chain fatty acids
Baseline and week 12
Heart Rate variability (HRV)
Time Frame: Baseline and week 12
Autonomic nervous function (ANS) will be assessed with HRV.
Baseline and week 12
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)
Baseline and week 12
Concentration of Red Blood Cell (RBC) Polyunsaturated Fatty Acids (PUFAs)
Time Frame: Baseline and week 12
Measurement of RBC PUFAs units in %
Baseline and week 12
Cognitive function: memory (Wechsler Memory Scale, WMS)
Time Frame: Baseline and week 12
WMS will be used to measure memory function of the subjects.
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
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.
Baseline and week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
China Medical University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Pei-Chen Chang, MD, PhD, China Medical University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 15, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 22, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 26, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 26, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CMUH110-REC3-113

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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