Open Label of Clinical Trial of Sulforaphane in Children With Autism

Autism Clinical Trial

Official title:

An Examination of Changes in Urinary Metabolites With Use of an Antioxidant Supplement, Sulforaphane, in School-aged Children With Autism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02654743
• Other study ID #: SF15-17002
• Status: Completed
• Phase: Phase 3
• Start date: January 2016
• Est. completion date: September 2016

Study information

• Verified date: March 2019
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an open-label, 4-month study examining the effects of Sulforaphane (SF) on behavior in children with ASD and the correlation between behavior change and urinary metabolites. The goal is to determine a potential mechanism of action of SF in this population.

Description:

Sulforaphane (SF) is an isothiocyanate found in high levels in crucifers belonging to the family Brassicaceae (including broccoli, cabbage, cauliflower, brussels sprouts, Chinese cabbage and turnips). Many previous studies have documented that consumption of these vegetables is associated with a reduced risk of cancer (lung, breast, colon, rectum, and prostate).(Juge et al. 2007) The mechanism of action of these beneficial effects is believed to be due to the ability of SF to up-regulate genes that improve cellular response to oxidative stress, inflammation, DNA-damaging electrophiles, and radiation.(Singh et al. 2014) In a recent small, randomized controlled trial in children with autism, SF was shown to have beneficial effects on aberrant and social behavior.(Singh et al. 2014) The mechanism of action of this beneficial effect has not been established in children with ASD. Our primary goal is to examine changes in urinary metabolites in children with autism who receive SF to determine if changes in behavior are associated with changes in urinary metabolites.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: September 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 22 Years

Eligibility

Inclusion Criteria:

• Male or female, enrolled at OHS, age 6-22 and with a diagnosis of ASD.

• ASD diagnosis will be established by standard criteria (DSM-IV criteria and expert clinician review of medical records and child observation).

• Written informed consent obtained from the subject's legal representative and ability for subject to comply with the requirements of the study.

Exclusion Criteria:

• Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.

Related Conditions & MeSH terms

• Autism
• Autistic Disorder

Intervention

Dietary Supplement:
• Sulforaphane
Children with ASD will receive Sulforaphane in this study

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary metabolites	Urine samples will be analyzed by lab and result will be provided	3 month
Primary	Behavior Measures	Measuring behavior using ABC (Aberrant Behavior Checklist)- self reported 58 questions from 0-3 scale (0-not a problem; 3=severe problem)	3 months