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NCT Number: NCT02879110

A 12-weeks Study to Evaluate 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.

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Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

3 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Guangzhou Huiai Hospital, Guangzhou, Guangdong, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 3 to 15 years.
  • 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

  • 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.)
  • With severe central nervous system disease (i.e. epilepsy et al).
  • With other specific genetic syndromes (i.e. Fragile-X syndrome, Down's syndrome et al.)

Treatment and study plan

Sulforaphane

Dietary Supplement

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

Other

Placebo tablet is composed of starch.

Other names: Starch tablet

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. The change of heart rate as measured by stopwatch

    Time frame: At baseline and 12 week/endpoint

  7. The change of weight as measured by weighing-machine

    Time frame: At baseline and 12 week/endpoint

  8. The change of height as measured by Height measurement tools

    Time frame: At baseline and 12 week/endpoint

  9. The change of blood routine test as tested by clinical laboratory

    Time frame: At baseline and 12 week/endpoint

  10. The change of fasting blood-glucose as tested by clinical laboratory

    Time frame: At baseline and 12 week/endpoint

  11. The change of blood lipid as tested by clinical laboratory

    Time frame: At baseline and 12 week/endpoint

  12. The change of liver function as tested by clinical laboratory

    Time frame: At baseline and 12 week/endpoint

  13. The change of kidney function as tested by clinical laboratory

    Time frame: At baseline and 12 week/endpoint

  14. The change of thyroid function as tested by clinical laboratory

    Time frame: At baseline and 12 week/endpoint

  15. The change of HBV test as tested by clinical laboratory

    Time frame: At baseline and 12 week/endpoint

  16. The change of helicobacter pylori test as tested by clinical laboratory

    Time frame: At baseline and 12 week/endpoint

  17. The change of urine routine test as tested by clinical laboratory

    Time frame: At baseline and 12 week/endpoint

  18. 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

Other outcomes

  1. The change of Oxidative stress indexes as tested by Oxidative stress indexes detection kit

    Time frame: At baseline and 12 week/endpoint

  2. The change of Epigenetics indicators as tested by Epigenetics indicators

    Time frame: At baseline and 12 week/endpoint

  3. The change of Cytokines & Chemokines as tested by Cytokines & Chemokines detection kit

    Time frame: At baseline and 12 week/endpoint

  4. The change of Metabolites as tested by Metabolites detection kit

    Time frame: At baseline and 12 week/endpoint

  5. The change of RNA expression as tested by RNA expression detection kit

    Time frame: At baseline and 12 week/endpoint

  6. The change of intestinal microflora as tested by Metagenomic technique

    Time frame: At baseline and 12 week/endpoint

Sponsors and collaborators

Lead sponsor

Central South University

Other

Collaborators

  • Davis family funding
  • University of California
  • University of Illinois at Chicago

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Aug 25, 2016
Registry last updated
Jul 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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