A 12-weeks Study to Evaluate Sulforaphane in Treatment of Autism Spectrum Disorder
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional

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.
    

Intervention name(s): Sulforaphane; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 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.; Placebo tablet is composed of starch.
Other intervention name(s): 85313323; Starch tablet
Intervention MeSH terms: Sulforaphane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sulforaphane; clinic trial; Autism Spectrum Disorder; Efficacy; Safety; Mechanism