A 12-weeks Study to Evaluate Sulforaphane in Treatment of Autism Spectrum Disorder

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Autism Spectrum Disorder

Intervention / Treatment
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* Dietary Supplement: Sulforaphane
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: 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.)

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sulforaphane group<br>The patients will take sulforaphane for 12 weeks. | Dietary Supplement: Sulforaphane<br>* Sulforaphane (SFN) is a compound within the isothiocyanate group of organosulfur compounds. It is obtained from cruciferous vegetables such as broccoli, Brussels sprouts or cabbages.<br>* Other names: 85313323;|
| Placebo Comparator: Placebo group<br>The patients will take placebo for 12 weeks. | Other: Placebo<br>* Placebo tablet is composed of starch.<br>* Other names: Starch tablet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of social impairments of children with autism spectrum disorder | Social impairments are measured by Social Responsiveness Scale | At baseline, 4 week, 8 week and 12 week/endpoint | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of rigid interests and behaviors of children with autism spectrum disorder | Rigid interests and behaviors are measured by Repetitive Behavior Scale - Revised | At baseline, 4 week, 8 week and 12 week/endpoint | 
| The change of clinical symptoms of children with autism spectrum | Clinical symptoms are measured by Aberrant Behavior Checklist | At baseline, 4 week, 8 week and 12 week/endpoint | 
| The change of other behavioral problems of children with autism spectrum | Other behavioral problems are measured by Achenbach's Child Behavior Checklist | At baseline, 4 week, 8 week and 12 week/endpoint | 
| The change of adaptive behaviors of children with autism spectrum | Adaptive behaviors are measured by Adaptive Behavior Assessment System, Second Edition | At baseline, 4 week, 8 week and 12 week/endpoint | 
| The change of clinical general impression of children with autism spectrum | Clinical general impression is measured by Ohio State University Autism Clinical Global Impression | At baseline, 4 week, 8 week and 12 week/endpoint | 
| The change of heart rate as measured by stopwatch |  | At baseline and 12 week/endpoint | 
| The change of weight as measured by weighing-machine |  | At baseline and 12 week/endpoint | 
| The change of height as measured by Height measurement tools |  | At baseline 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 blood lipid as tested by clinical laboratory |  | 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 kidney function as tested by clinical laboratory |  | 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 HBV test 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 | 
| The change of urine routine 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sulforaphane, clinic trial, Autism Spectrum Disorder, Efficacy, Safety, Mechanism