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

China Medical University

Status: Enrolling

Conditions: ASD

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Omega-3

Study type: Interventional

Funder types: Other

Identifiers

NCT07365553

CMUH110-REC3-113

Details and patient eligibility

About

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

Full 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).

Enrollment: 50 estimated patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 3 patient groups, including a placebo group

Omega-3 (EPA)

Experimental group

Description:

EPA

Treatment:

Dietary Supplement: Omega-3

Placebo

Placebo Comparator group

Description:

Soybean Oil

Treatment:

Dietary Supplement: Placebo

Omega-3 (DHA)

Experimental group

Description:

DHA

Treatment:

Dietary Supplement: Omega-3