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

July 28, 2019 updated by: Jian-Jun Ou, Central South University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
110

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Guangzhou Huiai Hospital
    • Hunan
      • Changsha, Hunan, China, 410001
        • The second Xiangya Hospital of Central South University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Sulforaphane group
The patients will take sulforaphane for 12 weeks.
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 Names:
  • 85313323
Placebo Comparator: Placebo group
The patients will take placebo for 12 weeks.
Other: Placebo
Placebo tablet is composed of starch.
Other Names:
  • Starch tablet

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
At baseline, 4 week, 8 week and 12 week/endpoint

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
At baseline, 4 week, 8 week and 12 week/endpoint
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
At baseline, 4 week, 8 week and 12 week/endpoint
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
At baseline, 4 week, 8 week and 12 week/endpoint
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
At baseline, 4 week, 8 week and 12 week/endpoint
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
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
At baseline and 12 week/endpoint
The change of weight as measured by weighing-machine
Time Frame: At baseline and 12 week/endpoint
At baseline and 12 week/endpoint
The change of height as measured by Height measurement tools
Time Frame: At baseline and 12 week/endpoint
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
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
At baseline and 12 week/endpoint
The change of blood lipid as tested by clinical laboratory
Time Frame: At baseline and 12 week/endpoint
At baseline and 12 week/endpoint
The change of liver function as tested by clinical laboratory
Time Frame: At baseline and 12 week/endpoint
At baseline and 12 week/endpoint
The change of kidney function as tested by clinical laboratory
Time Frame: At baseline and 12 week/endpoint
At baseline and 12 week/endpoint
The change of thyroid function as tested by clinical laboratory
Time Frame: At baseline and 12 week/endpoint
At baseline and 12 week/endpoint
The change of HBV test as tested by clinical laboratory
Time Frame: At baseline and 12 week/endpoint
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
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
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
At 4 week, 8 week and 12 week/endpoint

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
The change of Oxidative stress indexes as tested by Oxidative stress indexes detection kit
Time Frame: At baseline and 12 week/endpoint
At baseline and 12 week/endpoint
The change of Epigenetics indicators as tested by Epigenetics indicators
Time Frame: At baseline and 12 week/endpoint
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
At baseline and 12 week/endpoint
The change of Metabolites as tested by Metabolites detection kit
Time Frame: At baseline and 12 week/endpoint
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
At baseline and 12 week/endpoint
The change of intestinal microflora as tested by Metagenomic technique
Time Frame: At baseline and 12 week/endpoint
At baseline and 12 week/endpoint

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Central South University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Illinois at Chicago
University of California
Davis family funding

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 15, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 25, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 30, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ASD201512

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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