An interventional study of Sulforaphane and Placebo in Autism Spectrum Disorder, sponsored by Central South University. Completed at 2 sites in China. Open to participants aged 3 Years to 15 Years. Per ClinicalTrials.gov, last updated 2019-07-30.
Sponsored by Central South University · Not applicable, Interventional, and Treatment
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.
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.
1,344 studies on the registry are indexed under Autistic Disorder; 334 are open to participants now.
This study's enrollment of 110 is above the median of 45 across 1,044 interventional studies indexed under Autistic Disorder.
Browse Autistic Disorder studies →Central South University is the lead sponsor of 126 studies on the registry; 29 are open to participants now.
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Exclusion Criteria:
The patients will take sulforaphane for 12 weeks.
Dietary Supplement: Sulforaphane
The patients will take placebo for 12 weeks.
Other: Placebo
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.
Also known as: 85313323
Placebo tablet is composed of starch.
Also known as: Starch tablet
The change of social impairments of children with autism spectrum disorder
Social impairments are measured by Social Responsiveness Scale
Time frame: At baseline, 4 week, 8 week and 12 week/endpoint
The change of rigid interests and behaviors of children with autism spectrum disorder
Rigid interests and behaviors are measured by Repetitive Behavior Scale - Revised
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At baseline, 4 week, 8 week and 12 week/endpoint
The change of heart rate as measured by stopwatch
Time frame: At baseline and 12 week/endpoint
The change of weight as measured by weighing-machine
Time frame: At baseline and 12 week/endpoint
The change of height as measured by Height measurement tools
Time frame: At baseline and 12 week/endpoint
The change of blood routine test as tested by clinical laboratory
Time frame: At baseline and 12 week/endpoint
The change of fasting blood-glucose as tested by clinical laboratory
Time frame: At baseline and 12 week/endpoint
The change of blood lipid as tested by clinical laboratory
Time frame: At baseline and 12 week/endpoint
The change of liver function as tested by clinical laboratory
Time frame: At baseline and 12 week/endpoint
The change of kidney function as tested by clinical laboratory
Time frame: At baseline and 12 week/endpoint
The change of thyroid function as tested by clinical laboratory
Time frame: At baseline and 12 week/endpoint
The change of HBV test as tested by clinical laboratory
Time frame: At baseline and 12 week/endpoint
The change of helicobacter pylori test as tested by clinical laboratory
Time frame: At baseline and 12 week/endpoint
The change of urine routine test as tested by clinical laboratory
Time frame: At baseline and 12 week/endpoint
Number of participants with treatment-related adverse events as assessed by Systematic Assessment for Treatment Emergent Effects
Time frame: At 4 week, 8 week and 12 week/endpoint
The change of Oxidative stress indexes as tested by Oxidative stress indexes detection kit
Time frame: At baseline and 12 week/endpoint
The change of Epigenetics indicators as tested by Epigenetics indicators
Time frame: At baseline and 12 week/endpoint
The change of Cytokines & Chemokines as tested by Cytokines & Chemokines detection kit
Time frame: At baseline and 12 week/endpoint
The change of Metabolites as tested by Metabolites detection kit
Time frame: At baseline and 12 week/endpoint
The change of RNA expression as tested by RNA expression detection kit
Time frame: At baseline and 12 week/endpoint
The change of intestinal microflora as tested by Metagenomic technique
Time frame: At baseline and 12 week/endpoint
Plan to share: Undecided
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Central South University