Autism Spectrum Disorder
Conditions
Keywords
Sulforaphane, clinic trial, Autism Spectrum Disorder, Efficacy, Safety, Mechanism
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.
Interventions
DIETARY_SUPPLEMENTSulforaphane
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.
OTHERPlacebo
Placebo tablet is composed of starch.
Sponsors
Davis family funding
University of California
University of Illinois at Chicago
Central South University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 3 to 15 years. 2. 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
1. 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.) 2. With severe central nervous system disease (i.e. epilepsy et al). 3. With other specific genetic syndromes (i.e. Fragile-X syndrome, Down's syndrome et al.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| The change of weight as measured by weighing-machine | 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 | — |
| 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 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 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 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 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 heart rate as measured by stopwatch | 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 | — |
Other
| Measure | Time frame |
|---|---|
| The change of Cytokines & Chemokines as tested by Cytokines & Chemokines detection kit | At baseline and 12 week/endpoint |
| The change of Metabolites as tested by Metabolites detection kit | At baseline and 12 week/endpoint |
| The change of RNA expression as tested by RNA expression detection kit | At baseline and 12 week/endpoint |
| The change of intestinal microflora as tested by Metagenomic technique | At baseline and 12 week/endpoint |
| The change of Oxidative stress indexes as tested by Oxidative stress indexes detection kit | At baseline and 12 week/endpoint |
| The change of Epigenetics indicators as tested by Epigenetics indicators | At baseline and 12 week/endpoint |
Countries
China
Outcome results
None listed