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

NCT02879110 | Completed DMC

• 1 other identifier: ASD201512
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 2

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.

Conditions

Autism Spectrum Disorder

Keywords

Sulforaphane; clinic trial; Autism Spectrum Disorder; Efficacy; Safety; Mechanism

Outcome Measures

Primary Outcomes (1)

• The change of social impairments of children with autism spectrum disorder

  Social impairments are measured by Social Responsiveness Scale

  At baseline, 4 week, 8 week and 12 week/endpoint

Secondary Outcomes (18)

• The change of rigid interests and behaviors of children with autism spectrum disorder

  At baseline, 4 week, 8 week and 12 week/endpoint

• The change of clinical symptoms of children with autism spectrum

  At baseline, 4 week, 8 week and 12 week/endpoint

• The change of other behavioral problems of children with autism spectrum

  At baseline, 4 week, 8 week and 12 week/endpoint

• The change of adaptive behaviors of children with autism spectrum

  At baseline, 4 week, 8 week and 12 week/endpoint

• The change of clinical general impression of children with autism spectrum

  At baseline, 4 week, 8 week and 12 week/endpoint

Other Outcomes (6)

• The change of Oxidative stress indexes as tested by Oxidative stress indexes detection kit

  At baseline and 12 week/endpoint

• The change of Epigenetics indicators as tested by Epigenetics indicators

  At baseline and 12 week/endpoint

• The change of Cytokines & Chemokines as tested by Cytokines & Chemokines detection kit

  At baseline and 12 week/endpoint

Study Arms (2)

Sulforaphane group

EXPERIMENTAL

The patients will take sulforaphane for 12 weeks.

Dietary Supplement: Sulforaphane

Placebo group

PLACEBO COMPARATOR

The patients will take placebo for 12 weeks.

Other: Placebo

Interventions

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.

Also known as: 85313323

Sulforaphane group

Placebo OTHER

Placebo tablet is composed of starch.

Also known as: Starch tablet

Placebo group

Eligibility Criteria

• Age: 3 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Central South University: lead
• Davis family funding: collaborator
• University of California: collaborator
• University of Illinois at Chicago: collaborator

Study Sites (2)

Guangzhou Huiai Hospital

Guangzhou, Guangdong, 510000, China

Location

The second Xiangya hospital of central south university

Changsha, Hunan, 410001, China

Location

Related Publications (12)

• 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.

  PMID: 24486700 BACKGROUND

• 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.

  PMID: 24147970 BACKGROUND

• 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.

  PMID: 24103642 BACKGROUND

• 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.

  PMID: 22683514 BACKGROUND

• 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.

  PMID: 18381511 BACKGROUND

• 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.

  PMID: 18595965 BACKGROUND

• 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.

  PMID: 17466072 BACKGROUND

• 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.

  PMID: 17259330 BACKGROUND

• 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.

  PMID: 25608486 BACKGROUND

• 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.

  PMID: 22143005 BACKGROUND

• 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.

  PMID: 17272578 BACKGROUND

• 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.

  PMID: 25313065 BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

sulforaphane; Starch

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Polysaccharides

Study Officials

• Jingping Zhao, M.D., Ph. D.

  Central South University

  STUDY CHAIR

• Jianjun Ou, M.D., Ph. D.

  Central South University

  STUDY DIRECTOR

• Hua Jin, M.D., Ph. D.

  Department of Psychiatry, University of California

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

• John M Davis, M.D.,Ph.D

  Department of Psychiatry, University of Illinoisat at Chicago

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant researcher

Study Record Dates

• First Submitted: August 15, 2016
• First Posted: August 25, 2016
• Study Start: August 1, 2016
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: July 30, 2019

Record last verified: 2019-07

Locations

CN (2)