China Medical University
Taichung, 404, Taiwan
Location status: Recruiting
Location contact
Pei-Chen Chang, MD, PHD
CONTACT
Pei-Chen Chang, MD, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07365553
This is a 12 week study to investigate the effects of omega-3 polyunsaturated fatty acids (PUFAs) in youth with autism spectrum disorder (ASD).
Interested in participating?
Request Info6 year–17 year
All sexes
Interventional
Not applicable
Taichung, 404, Taiwan
Location status: Recruiting
Pei-Chen Chang, MD, PHD
CONTACT
Pei-Chen Chang, MD, PhD
PRINCIPAL_INVESTIGATOR
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Omega-3 PUFAs
Soybean Oil
Time frame: 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
Time frame: Baseline and week 12
Interleukin (IL)-1 beta (picogram/milliliter, pg/ML) IL-6 IL-10 Tumor necrosis factor -αlpha Interferon (IFN)-γ
Time frame: Baseline and week 12
CPT will be used to measure the attention and impulsivity in the subjects.
Time frame: 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.
Time frame: Baseline and week 12
Gut microbiomal sequencing, Faecal short-chain fatty acids
Time frame: Baseline and week 12
Autonomic nervous function (ANS) will be assessed with HRV.
Time frame: Baseline and week 12
measurement of peripheral blood hs-CRP units in milligram/Liter (mg/L)
Time frame: Baseline and week 12
Measurement of RBC PUFAs units in %
Time frame: Baseline and week 12
WMS will be used to measure memory function of the subjects.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
China Medical University Hospital
Other
Omega-3 Fatty Acids and Autism Spectrum Disorder (ASD) - A Double-blind Randomized Controlled Trial of Omega-3 Fatty Acids in Youth With ASD
Acronym: OMeASD
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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