Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02879110
Recruitment Status : Completed
First Posted : August 25, 2016
Last Update Posted : July 30, 2019
Sponsor:
Collaborators:
Davis family funding
University of California
University of Illinois at Chicago
Information provided by (Responsible Party):
Jian-Jun Ou, Central South University

Tracking Information
First Submitted Date  ICMJE August 15, 2016
First Posted Date  ICMJE August 25, 2016
Last Update Posted Date July 30, 2019
Study Start Date  ICMJE August 2016
Actual Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 22, 2016)
The change of social impairments of children with autism spectrum disorder [ Time Frame: At baseline, 4 week, 8 week and 12 week/endpoint ]
Social impairments are measured by Social Responsiveness Scale
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2016)
  • The change of rigid interests and behaviors of children with autism spectrum disorder [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 22, 2018)
  • 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 ]
Original Other Pre-specified Outcome Measures
 (submitted: August 22, 2016)
  • 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 ]
 
Descriptive Information
Brief Title  ICMJE A 12-weeks Study to Evaluate Sulforaphane in Treatment of Autism Spectrum Disorder
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Autism Spectrum Disorder
Intervention  ICMJE
  • Dietary Supplement: Sulforaphane
    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.
    Other Name: 85313323
  • Other: Placebo
    Placebo tablet is composed of starch.
    Other Name: Starch tablet
Study Arms  ICMJE
  • Experimental: Sulforaphane group
    The patients will take sulforaphane for 12 weeks.
    Intervention: Dietary Supplement: Sulforaphane
  • Placebo Comparator: Placebo group
    The patients will take placebo for 12 weeks.
    Intervention: Other: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 28, 2019)
110
Original Estimated Enrollment  ICMJE
 (submitted: August 22, 2016)
120
Actual Study Completion Date  ICMJE July 2019
Actual Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 15 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02879110
Other Study ID Numbers  ICMJE ASD201512
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Jian-Jun Ou, Central South University
Study Sponsor  ICMJE Central South University
Collaborators  ICMJE
  • Davis family funding
  • University of California
  • University of Illinois at Chicago
Investigators  ICMJE
Study Chair: Jingping Zhao, M.D., Ph. D. Central South University
Study Director: Jianjun Ou, M.D., Ph. D. Central South University
Study Director: Hua Jin, M.D., Ph. D. Department of Psychiatry, University of California
Principal Investigator: Fengyu Zhang, Ph.D. Global Clinical and Translational Research Institute
Principal Investigator: Daomeng Cheng, M.D. Guangzhou Huiai Hospital
Principal Investigator: Renrong Wu, M.D.,Ph.D Central South University
Study Director: John M Davis, M.D.,Ph.D Department of Psychiatry, University of Illinoisat at Chicago
PRS Account Central South University
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP