A 12-weeks Study to Evaluate Sulforaphane in Treatment of Autism Spectrum Disorder
- Conditions
- Autism Spectrum Disorder
- Interventions
- Other: PlaceboDietary Supplement: Sulforaphane
- Registration Number
- NCT02879110
- Lead Sponsor
- Central South University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 110
- 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).
- 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.)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo group Placebo The patients will take placebo for 12 weeks. Sulforaphane group Sulforaphane The patients will take sulforaphane for 12 weeks.
- Primary Outcome Measures
Name Time Method The change of social impairments of children with autism spectrum disorder At baseline, 4 week, 8 week and 12 week/endpoint Social impairments are measured by Social Responsiveness Scale
- Secondary Outcome Measures
Name Time Method The change of other behavioral problems of children with autism spectrum At baseline, 4 week, 8 week and 12 week/endpoint Other behavioral problems are measured by Achenbach's Child Behavior Checklist
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 Clinical symptoms are measured by Aberrant Behavior Checklist
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 Rigid interests and behaviors are measured by Repetitive Behavior Scale - Revised
The change of clinical general impression of children with autism spectrum At baseline, 4 week, 8 week and 12 week/endpoint Clinical general impression is measured by Ohio State University Autism Clinical Global Impression
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 Adaptive behaviors are measured by Adaptive Behavior Assessment System, Second Edition
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
Trial Locations
- Locations (2)
Guangzhou Huiai Hospital
🇨🇳Guangzhou, Guangdong, China
The second Xiangya hospital of central south university
🇨🇳Changsha, Hunan, China