Actively Recruiting
Omega-3 Fatty Acids and Autism Spectrum Disorder (ASD) - A Double-blind Randomized Controlled Trial of Omega-3 Fatty Acids in Youth With ASD
Led by China Medical University Hospital · Updated on 2026-01-26
50
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of omega-3 polyunsaturated fatty acids (PUFAs) on children and teenagers aged 6 to 17 years with autism spectrum disorder (ASD). This 12-week study aims to understand how omega-3 supplements may influence behavioral symptoms and other health markers in youth with ASD. The primary focus is on clinical symptoms measured by the Aberrant Behavior Checklist (ABC). Participants will be randomly assigned to receive one of three treatments: omega-3 EPA, omega-3 DHA, or a placebo containing soybean oil. This is a double-blind trial, meaning neither the participants nor the researchers know which treatment is given to ensure unbiased results. The study lasts for 12 weeks, during which participants take their assigned supplements. Throughout the study, participants will undergo multiple assessments including behavioral symptom ratings at several time points, blood tests for inflammatory markers and fatty acid levels, cognitive tests for attention and memory, stool sample collection, and measurement of heart rate variability. These evaluations occur at the start and end of the study, with some behavioral checks also done during weeks 1, 2, 4, and 8. The research team will monitor participant health and responses to understand the impact of omega-3 on ASD symptoms and related physiological changes.
CONDITIONS
Brief Title
Omega-3, Autism Spectrum Disorder (ASD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of DSM5 autism spectrum disorder (ASD) made by child and adolescent psychiatrist
- Age 6 to 17 years old at the time of enrollment
- No pharmacotherapy or non-pharmacotherapy adjustments within the past 4 weeks
- Signed informed consent
You will not qualify if you...
- Comorbid psychiatric disorders including schizophrenia, bipolar disorder, major depressive disorder, or substance use disorder
- Comorbid physical disorders such as thyroid dysfunction, cerebral palsy, or coagulation disorders
- Current use of omega-3 supplements or probiotics
- Allergy to omega-3
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 12 weeks
Participants receive omega-3 fatty acids or placebo to assess effects on symptoms and biomarkers of autism spectrum disorder.
Weekly visits for up to 12 weeks
Trial Site Locations
Total: 1 location
1
China Medical University
Taichung, Taichung, Taiwan, 404
Actively Recruiting
Research Team
P
Pei-Chen Chang, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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