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

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.

Conditions

• Autism Spectrum Disorder

Interventions

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

Placebo

Placebo tablet is composed of starch.

Sponsors & Collaborators

• Davis family funding

  collaborator UNKNOWN

• University of California

  collaborator OTHER

• University of Illinois at Chicago

  collaborator OTHER

• Central South University

  lead OTHER

Principal Investigators

• Jingping Zhao, M.D., Ph. D. · Central South University

• Jianjun Ou, M.D., Ph. D. · Central South University

• Hua Jin, M.D., Ph. D. · Department of Psychiatry, University of California

• Fengyu Zhang, Ph.D. · Global Clinical and Translational Research Institute

• Daomeng Cheng, M.D. · Guangzhou Huiai Hospital

• Renrong Wu, M.D.,Ph.D · Central South University

• John M Davis, M.D.,Ph.D · Department of Psychiatry, University of Illinoisat at Chicago

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

3 Years

Max Age

15 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-08-31

Primary Completion

2019-07-31

Completion

2019-07-31

Countries

• China

Study Locations