Open Label of Clinical Trial of Sulforaphane in Children With Autism

NCT02654743 | Completed Phase 3

• 1 other identifier: SF15-17002
• Study Type: interventional
• Target: 21
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Autism

Outcome Measures

Primary Outcomes (2)

• Urinary metabolites

  Urine samples will be analyzed by lab and result will be provided

  3 month

• 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

Study Arms (1)

SF

EXPERIMENTAL

Sulforaphane (SF) will be administered in an approximate dosage of 1 µmol SF/lb (2.2 kg µmol/kg) body weight. This dosage roughly approximates the dosage that was used in the Singh et al, (2014; PNAS) clinical trial of sulforaphane in male adolescents and adults with autism. The sulforaphane will be supplied as glucoraphanin (GR)-enriched broccoli seed extract tablets (manufacturing details follow). Each active tablet will contain 125 mg broccoli seed extract (containing 37 µmol GR, which is equivalent to about 15 µmol SF), 50 mg dried broccoli sprouts (a source of myrosinase, the enzyme that converts GR to SF), 15 mg ascorbic acid, 55.90 mg microcrystalline cellulose, and other minor GRAS excipients used for tablet forming. The total dose per day will depend of study participants' body weight.

Dietary Supplement: Sulforaphane

Interventions

Sulforaphane DIETARY_SUPPLEMENT

Children with ASD will receive Sulforaphane in this study

SF

Eligibility Criteria

• Age: 5 Years - 22 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead

Related Publications (1)

• 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.

  PMID: 29854372 DERIVED

MeSH Terms

Conditions

Autistic Disorder

Interventions

sulforaphane

Condition Hierarchy (Ancestors)

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

Study Officials

• Robert Hendren, DO

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2016
• First Posted: January 13, 2016
• Study Start: January 1, 2016
• Primary Completion: May 1, 2016
• Study Completion: September 1, 2016
• Last Updated: March 6, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share