Omega-3, Autism Spectrum Disorder (ASD)
ConditionASD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-17
SponsorChina Medical University Hospital
About this trial
This is a 12 week study to investigate the effects of omega-3 polyunsaturated fatty acids (PUFAs) in youth with autism spectrum disorder (ASD).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Design model
Parallel
Treatments tested in this trial
Omega-3
Dietary supplementOmega-3 PUFAs
Placebo
Dietary supplementSoybean Oil
Treatment groups
50 Participants
are divided into 3 treatment groupsGroup A: Omega-3 (EPA)Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Group C: Omega-3 (DHA)Experimental treatment 1 intervention
Trial outcomes
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
Time frame
Baseline, week 1,2,4,8,12Secondary outcomes
1
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
Time frame
Baseline and week 122
Cognitive function-attention and impulsivity (Continuous Performance Test, CPT)
CPT will be used to measure the attention and impulsivity in the subjects.
Time frame
Baseline and week 123
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.
Time frame
Baseline and week 124
Stool Sample
Gut microbiomal sequencing, Faecal short-chain fatty acids
Time frame
Baseline and week 12Sponsors and contacts
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Source ClinicalTrials.gov