Clinical trial NCT02654743: Open Label of Clinical Trial of Sulforaphane in Children With Autism
Official title: An Examination of Changes in Urinary Metabolites With Use of an Antioxidant Supplement, Sulforaphane, in School-aged Children With Autism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Autism
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2016-01-13
Enrollment: 21
Sex: ALL
Minimum age (years): 5
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Urinary metabolites
timeFrame: 3 month
measure: Behavior Measures
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of California, San Francisco
name: Robert Hendren, DO
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bent S, Lawton B, Warren T, Widjaja F, Dang K, Fahey JW, Cornblatt B, Kinchen JM, Delucchi K, Hendren RL. Identification of urinary metabolites that correlate with clinical improvements in children with autism treated with sulforaphane from broccoli. Mol Autism. 2018 May 30;9:35. doi: 10.1186/s13229-018-0218-4. eCollection 2018.