A 12-weeks, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Related Mechanism of Sulforaphane in Treatment of Autism Spectrum Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- The change of social impairments of children with autism spectrum disorder
研究概览
简要总结
In this proposed study, the investigators will evaluate the the efficacy, safety and related mechanism of sulforaphane in treatment of autism spectrum disorder (ASD). The study will recruit 120 ASD patients, then these patients will be randomized to sulforaphane group or placebo group (60 patients per arm) for 12 weeks clinic trial. Clinical efficacy and safety assessment will be done at screen/baseline, 4 week, 8 week and 12 week. The specific aims are to compare sulforaphane versus placebo on: 1) clinical core symptoms; 2) other behavioral problems and adaptive behaviors. Biological samples also will be collected, and stored to research related mechanisms.
详细描述
In this proposed study, the investigators will evaluate the the efficacy, safety and related mechanism of sulforaphane in treatment of autism spectrum disorder (ASD). The study will recruit 120 ASD patients, then these patients will be randomized to sulforaphane group or placebo group (60 patients per arm) for 12 weeks clinic trial. Clinical efficacy and safety assessment will be done at screen/baseline, 4 week, 8 week and 12 week. The specific aims are to compare sulforaphane versus placebo on: 1) clinical core symptoms; 2) other behavioral problems and adaptive behaviors. The investigators hypothesize that (1) sulforaphane is superior to placebo in the treatment of clinical symptoms in patients with ASD, measured by the Social Responsiveness Scale, Aberrant Behavior Checklist, Repetitive Behavior Scale - Revised and Ohio State University Autism Clinical Global Impression; (2) sulforaphane is superior to placebo in the treatment of other behavioral problems and adaptive behaviors patients with ASD, measured by Achenbach's Child Behavior Checklist and Adaptive Behavior Assessment System, Second Edition; and (3) Biological samples will be collected, and stored so that the hypothesis sulforaphane may alter oxidative stress indexes or inflammatory biomarkers, and influence histone deacetylase inhibitor mechanism or inflammatory mechanism et al that may be significantly correlated with clinical improvement.
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)
入排标准
- 年龄范围
- 3 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 3 to 15 years.
- •Meet DSM-V diagnostic criteria for autism spectrum disorder, and been checked with Autism Diagnostic Interview-Revised (ADI-R) and Autism Diagnostic Observation Schedule (ADOS).
排除标准
- •With severe physical disease (i.e. congenital heart disease, thyroid disease, diseases with severe abnormality of liver or kidney function, diseases with abnormality vision or hearing et al.)
- •With severe central nervous system disease (i.e. epilepsy et al).
- •With other specific genetic syndromes (i.e. Fragile-X syndrome, Down's syndrome et al.)
结局指标
主要结局
The change of social impairments of children with autism spectrum disorder
时间窗: At baseline, 4 week, 8 week and 12 week/endpoint
Social impairments are measured by Social Responsiveness Scale
次要结局
- The change of other behavioral problems of children with autism spectrum(At baseline, 4 week, 8 week and 12 week/endpoint)
- The change of height as measured by Height measurement tools(At baseline and 12 week/endpoint)
- The change of blood lipid as tested by clinical laboratory(At baseline and 12 week/endpoint)
- The change of clinical symptoms of children with autism spectrum(At baseline, 4 week, 8 week and 12 week/endpoint)
- The change of HBV test as tested by clinical laboratory(At baseline and 12 week/endpoint)
- The change of urine routine test as tested by clinical laboratory(At baseline and 12 week/endpoint)
- The change of rigid interests and behaviors of children with autism spectrum disorder(At baseline, 4 week, 8 week and 12 week/endpoint)
- The change of clinical general impression of children with autism spectrum(At baseline, 4 week, 8 week and 12 week/endpoint)
- The change of blood routine test as tested by clinical laboratory(At baseline and 12 week/endpoint)
- The change of fasting blood-glucose as tested by clinical laboratory(At baseline and 12 week/endpoint)
- The change of kidney function as tested by clinical laboratory(At baseline and 12 week/endpoint)
- The change of heart rate as measured by stopwatch(At baseline and 12 week/endpoint)
- The change of liver function as tested by clinical laboratory(At baseline and 12 week/endpoint)
- The change of adaptive behaviors of children with autism spectrum(At baseline, 4 week, 8 week and 12 week/endpoint)
- The change of weight as measured by weighing-machine(At baseline and 12 week/endpoint)
- The change of thyroid function as tested by clinical laboratory(At baseline and 12 week/endpoint)
- The change of helicobacter pylori test as tested by clinical laboratory(At baseline and 12 week/endpoint)
- Number of participants with treatment-related adverse events as assessed by Systematic Assessment for Treatment Emergent Effects(At 4 week, 8 week and 12 week/endpoint)
研究者
Jian-Jun Ou
Assistant researcher
Central South University