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

NCT ID: NCT02879110

Last Updated: 2019-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2019-07-31

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.

Conditions

Autism Spectrum Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Sulforaphane group

The patients will take sulforaphane for 12 weeks.

Group Type: EXPERIMENTAL

Sulforaphane

Intervention Type: 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.

Placebo group

The patients will take placebo for 12 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo tablet is composed of starch.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo tablet is composed of starch.

Intervention Type: OTHER

Other Intervention Names

85313323; Starch tablet

Eligibility Criteria

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.)

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Davis family funding

UNKNOWN

Sponsor Role: collaborator

University of California

OTHER

Sponsor Role: collaborator

University of Illinois at Chicago

OTHER

Sponsor Role: collaborator

Central South University

OTHER

Sponsor Role: lead

Responsible Party

Jian-Jun Ou

Assistant researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jingping Zhao, M.D., Ph. D.

Role: STUDY_CHAIR

Central South University

Jianjun Ou, M.D., Ph. D.

Role: STUDY_DIRECTOR

Central South University

Hua Jin, M.D., Ph. D.

Role: STUDY_DIRECTOR

Department of Psychiatry, University of California

Fengyu Zhang, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Global Clinical and Translational Research Institute

Daomeng Cheng, M.D.

Role: PRINCIPAL_INVESTIGATOR

Guangzhou Huiai Hospital

Renrong Wu, M.D.,Ph.D

Role: PRINCIPAL_INVESTIGATOR

Central South University

John M Davis, M.D.,Ph.D

Role: STUDY_DIRECTOR

Department of Psychiatry, University of Illinoisat at Chicago

Locations

Guangzhou Huiai Hospital

Guangzhou, Guangdong, China

The second Xiangya hospital of central south university

Changsha, Hunan, China

Countries

China

References

Foley AG, Cassidy AW, Regan CM. Pentyl-4-yn-VPA, a histone deacetylase inhibitor, ameliorates deficits in social behavior and cognition in a rodent model of autism spectrum disorders. Eur J Pharmacol. 2014 Mar 15;727:80-6. doi: 10.1016/j.ejphar.2014.01.050. Epub 2014 Jan 31.

Reference Type: BACKGROUND

PMID: 24486700 (View on PubMed)

Houghton CA, Fassett RG, Coombes JS. Sulforaphane: translational research from laboratory bench to clinic. Nutr Rev. 2013 Nov;71(11):709-26. doi: 10.1111/nure.12060. Epub 2013 Oct 22.

Reference Type: BACKGROUND

PMID: 24147970 (View on PubMed)

Moldrich RX, Leanage G, She D, Dolan-Evans E, Nelson M, Reza N, Reutens DC. Inhibition of histone deacetylase in utero causes sociability deficits in postnatal mice. Behav Brain Res. 2013 Nov 15;257:253-64. doi: 10.1016/j.bbr.2013.09.049. Epub 2013 Oct 5.

Reference Type: BACKGROUND

PMID: 24103642 (View on PubMed)

Foley AG, Gannon S, Rombach-Mullan N, Prendergast A, Barry C, Cassidy AW, Regan CM. Class I histone deacetylase inhibition ameliorates social cognition and cell adhesion molecule plasticity deficits in a rodent model of autism spectrum disorder. Neuropharmacology. 2012 Sep;63(4):750-60. doi: 10.1016/j.neuropharm.2012.05.042. Epub 2012 Jun 6.

Reference Type: BACKGROUND

PMID: 22683514 (View on PubMed)

Montes G, Halterman JS. Association of childhood autism spectrum disorders and loss of family income. Pediatrics. 2008 Apr;121(4):e821-6. doi: 10.1542/peds.2007-1594.

Reference Type: BACKGROUND

PMID: 18381511 (View on PubMed)

Montes G, Halterman JS. Child care problems and employment among families with preschool-aged children with autism in the United States. Pediatrics. 2008 Jul;122(1):e202-8. doi: 10.1542/peds.2007-3037.

Reference Type: BACKGROUND

PMID: 18595965 (View on PubMed)

Mugno D, Ruta L, D'Arrigo VG, Mazzone L. Impairment of quality of life in parents of children and adolescents with pervasive developmental disorder. Health Qual Life Outcomes. 2007 Apr 27;5:22. doi: 10.1186/1477-7525-5-22.

Reference Type: BACKGROUND

PMID: 17466072 (View on PubMed)

Myzak MC, Tong P, Dashwood WM, Dashwood RH, Ho E. Sulforaphane retards the growth of human PC-3 xenografts and inhibits HDAC activity in human subjects. Exp Biol Med (Maywood). 2007 Feb;232(2):227-34.

Reference Type: BACKGROUND

PMID: 17259330 (View on PubMed)

Ou JJ, Shi LJ, Xun GL, Chen C, Wu RR, Luo XR, Zhang FY, Zhao JP. Employment and financial burden of families with preschool children diagnosed with autism spectrum disorders in urban China: results from a descriptive study. BMC Psychiatry. 2015 Jan 22;15:3. doi: 10.1186/s12888-015-0382-4.

Reference Type: BACKGROUND

PMID: 25608486 (View on PubMed)

Rossignol DA, Frye RE. A review of research trends in physiological abnormalities in autism spectrum disorders: immune dysregulation, inflammation, oxidative stress, mitochondrial dysfunction and environmental toxicant exposures. Mol Psychiatry. 2012 Apr;17(4):389-401. doi: 10.1038/mp.2011.165. Epub 2011 Dec 6.

Reference Type: BACKGROUND

PMID: 22143005 (View on PubMed)

Schieve LA, Blumberg SJ, Rice C, Visser SN, Boyle C. The relationship between autism and parenting stress. Pediatrics. 2007 Feb;119 Suppl 1:S114-21. doi: 10.1542/peds.2006-2089Q.

Reference Type: BACKGROUND

PMID: 17272578 (View on PubMed)

Singh K, Connors SL, Macklin EA, Smith KD, Fahey JW, Talalay P, Zimmerman AW. Sulforaphane treatment of autism spectrum disorder (ASD). Proc Natl Acad Sci U S A. 2014 Oct 28;111(43):15550-5. doi: 10.1073/pnas.1416940111. Epub 2014 Oct 13.

Reference Type: BACKGROUND

PMID: 25313065 (View on PubMed)

Other Identifiers

ASD201512

Identifier Type: -

Identifier Source: org_study_id