ASD
Conditions
Keywords
inflammation, adolescent, omega-3
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).
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).
Interventions
DIETARY_SUPPLEMENTOmega-3
Omega-3 PUFAs
DIETARY_SUPPLEMENTPlacebo
Soybean Oil
Sponsors
China Medical University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
double blind
Intervention model description
To investigate the effects of DHA, EPA and placebo in adolescents with ASD
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Symptoms-Behavioral problems (Aberrant Behavior Checklist, ABC) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of blood inflammatory biomarkers in pg/mL | Baseline and week 12 | Interleukin (IL)-1 beta (picogram/milliliter, pg/ML) IL-6 IL-10 Tumor necrosis factor -αlpha Interferon (IFN)-γ |
| Cognitive function-attention and impulsivity (Continuous Performance Test, CPT) | Baseline and week 12 | CPT will be used to measure the attention and impulsivity in the subjects. |
| Clinical symptoms: Behavioral problems (Strength and Difficulty Questionnaire, SDQ) | Baseline and week 12 | 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. |
| Stool Sample | Baseline and week 12 | Gut microbiomal sequencing, Faecal short-chain fatty acids |
| Heart Rate variability (HRV) | Baseline and week 12 | Autonomic nervous function (ANS) will be assessed with HRV. |
| Concentration of blood high-sensitivity C-reactive Protein (hs-CRP) | Baseline and week 12 | measurement of peripheral blood hs-CRP units in milligram/Liter (mg/L) |
| Concentration of Red Blood Cell (RBC) Polyunsaturated Fatty Acids (PUFAs) | Baseline and week 12 | Measurement of RBC PUFAs units in % |
| Cognitive function: memory (Wechsler Memory Scale, WMS) | Baseline and week 12 | WMS will be used to measure memory function of the subjects. |
| Clinical symptoms: attention and hyperactivity (Swanson, Nolan, and Pelham Rating Scale - Version IV, SNAP-IV) | Baseline and week 12 | 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. |
Countries
Taiwan
Contacts
CONTACTPei-Chen Chang, MD, PhD
PRINCIPAL_INVESTIGATORPei-Chen Chang, MD, PhD
China Medical University Hospital
Outcome results
None listed