Omega-3 Fatty Acids and Autism Spectrum Disorder (ASD) - A Double-blind Randomized Controlled Trial of Omega-3 Fatty Acids in Youth With ASD
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Clinical Symptoms-Behavioral problems (Aberrant Behavior Checklist, ABC)
研究概览
简要总结
This is a 12 week study to investigate the effects of omega-3 polyunsaturated fatty acids (PUFAs) in youth with autism spectrum disorder (ASD).
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
double blind
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Omega-3 (EPA)
EPA
干预措施: Omega-3 (Dietary Supplement)
Placebo
Soybean Oil
干预措施: Placebo (Dietary Supplement)
Omega-3 (DHA)
DHA
干预措施: Omega-3 (Dietary Supplement)
结局指标
主要结局
Clinical Symptoms-Behavioral problems (Aberrant Behavior Checklist, ABC)
时间窗: 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
次要结局
- Concentration of blood inflammatory biomarkers in pg/mL(Baseline and week 12)
- Cognitive function-attention and impulsivity (Continuous Performance Test, CPT)(Baseline and week 12)
- Cognitive function: memory (Wechsler Memory Scale, WMS)(Baseline and week 12)
- Clinical symptoms: Behavioral problems (Strength and Difficulty Questionnaire, SDQ)(Baseline and week 12)
- Stool Sample(Baseline and week 12)
- Heart Rate variability (HRV)(Baseline and week 12)
- Concentration of blood high-sensitivity C-reactive Protein (hs-CRP)(Baseline and week 12)
- Concentration of Red Blood Cell (RBC) Polyunsaturated Fatty Acids (PUFAs)(Baseline and week 12)
- Clinical symptoms: attention and hyperactivity (Swanson, Nolan, and Pelham Rating Scale - Version IV, SNAP-IV)(Baseline and week 12)
研究者
Pei-Chen Chang
PI
China Medical University Hospital