ASDOMeASDNCT07365553
Omega-3, Autism Spectrum Disorder (ASD)
A study testing Omega-3 in people with ASD, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
This is a 12 week study to investigate the effects of omega-3 polyunsaturated fatty acids (PUFAs) in youth with autism spectrum disorder (ASD). Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- ASD
- What is being tested?
- Omega-3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Jul 2022to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
China Medical University
Taichung, Taichung, 404
Pei-Chen Chang, MD, PHD, 886 4 22052121, 013121@tool.caaumed.org.tw
Pei-Chen Chang, MD, PhD
About this study
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
This is a 12 week study to investigate the effects of omega-3 polyunsaturated fatty acids (PUFAs) in youth with autism spectrum disorder (ASD).
Read the 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).
- Conditions
- ASD
- Being tested
- Omega-3, Placebo
- Keywords
- inflammation, adolescent, omega-3
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3Dietary supplement
Omega-3 PUFAs
PlaceboDietary supplement
Soybean Oil
| Study group | Role | What they receive |
|---|---|---|
| Omega-3 (EPA) | Experimental | EPA Receives: Dietary Supplement: Omega-3 |
| Placebo | Placebo comparator | Soybean Oil Receives: Dietary Supplement: Placebo |
| Omega-3 (DHA) | Experimental | DHA Receives: Dietary Supplement: Omega-3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, week 1,2,4,8,12
Secondary outcomes (9)
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
Measured: 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.
Measured: 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.
Measured: Baseline and week 12
Stool Sample
Gut microbiomal sequencing, Faecal short-chain fatty acids
Measured: Baseline and week 12
Heart Rate variability (HRV)
Autonomic nervous function (ANS) will be assessed with HRV.
Measured: 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)
Measured: Baseline and week 12
Concentration of Red Blood Cell (RBC) Polyunsaturated Fatty Acids (PUFAs)
Measurement of RBC PUFAs units in %
Measured: Baseline and week 12
Cognitive function: memory (Wechsler Memory Scale, WMS)
WMS will be used to measure memory function of the subjects.
Measured: 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.
Measured: Baseline and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start15 Jul 2022
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ASDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- To investigate the effects of DHA, EPA and placebo in adolescents with ASD
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pei-Chen Chang, China Medical University Hospital
- Investigators
- Pei-Chen Chang, MD, PhD, Principal investigator, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07365553
- Sponsor's protocol ID
- CMUH110-REC3-113
- Acronym
- OMeASD
- Status last verified
- Jan 2026
- First submitted
- 22 May 2024
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07365553
- Acronym / sponsor ID
- OMeASD / CMUH110-REC3-113
- Conditions
- ASD
- Keywords
- inflammation, adolescent, omega-3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 26 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- To investigate the effects of DHA, EPA and placebo in adolescents with ASD
| Arm | Type | Receives |
|---|---|---|
| Omega-3 (EPA) | Experimental | Dietary Supplement: Omega-3EPA |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboSoybean Oil |
| Omega-3 (DHA) | Experimental | Dietary Supplement: Omega-3DHA |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3Omega-3 PUFAs | Dietary supplement | Omega-3 (DHA), Omega-3 (EPA) |
| PlaceboSoybean Oil | Dietary supplement | Placebo |
Primary outcome
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
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pei-Chen Chang, MD, PhD principal investigator
China Medical University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega-3 in people with ASD, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pei-Chen Chang, MD, PhD (0422052121 ext. 4126, d13121@mail.cmuh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Symptoms-Behavioral problems (Aberrant Behavior Checklist, ABC) (time frame: Baseline, week 1,2,4,8,12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.