Omega-3, Autism Spectrum Disorder (ASD)

NCT07365553 | Recruiting

• 1 other identifier: CMUH110-REC3-113
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

ASD

Keywords

inflammation; adolescent; omega-3

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline, week 1,2,4,8,12

Secondary Outcomes (9)

• Concentration of blood inflammatory biomarkers in pg/mL

  Baseline and week 12

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

  Baseline and week 12

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

  Baseline and week 12

• Stool Sample

  Baseline and week 12

• Heart Rate variability (HRV)

  Baseline and week 12

Study Arms (3)

Omega-3 (EPA)

EXPERIMENTAL

EPA

Dietary Supplement: Omega-3

Placebo

PLACEBO COMPARATOR

Soybean Oil

Dietary Supplement: Placebo

Omega-3 (DHA)

EXPERIMENTAL

DHA

Dietary Supplement: Omega-3

Interventions

Omega-3 DIETARY_SUPPLEMENT

Omega-3 PUFAs

Omega-3 (DHA); Omega-3 (EPA)

Placebo DIETARY_SUPPLEMENT

Soybean Oil

Placebo

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University

Taichung, Taichung, 404, Taiwan

RECRUITING

MeSH Terms

Conditions

Inflammation

Interventions

Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Pei-Chen Chang, MD, PhD

  China Medical University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pei-Chen Chang, MD, PhD

CONTACT

0422052121; d13121@mail.cmuh.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Model Details: To investigate the effects of DHA, EPA and placebo in adolescents with ASD

Study Record Dates

• First Submitted: May 22, 2024
• First Posted: January 26, 2026
• Study Start: July 15, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)