Sulforaphane-rich Broccoli Sprout Extract for Autism

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: Male

Summary

The primary objectives of this study are to answer whether there is evidence of measurable effects on social responsiveness (primary outcome) and other behavioral symptoms after treatment of autistic male adolescents and adults with orally administered sulforaphane-rich Broccoli Sprout Extract (efficacy). The secondary objectives of this study are to answer whether treatment of male adolescents and adults with autism using orally administered sulforaphane-rich Broccoli Sprout Extract within a specified dose range is safe (toxicity); treatment with sulforaphane-rich Broccoli Sprout Extract is well tolerated (side effects and adverse events); key cellular biomarkers support the hypothesized mechanisms (proof of principle).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Andrew Zimmerman; University of Massachusetts, Worcester
• Collaborator: Johns Hopkins University
• Treatments: Sulforafan; Sulforaphane

Criteria

Inclusion Criteria:

• Autism diagnosis. Quantitative autism traits and severity for diagnosis of autism will be assessed using the ADOS-G (Modules 1-4 and Severity), Social Responsiveness Scale (SRS; child and adult forms), Clinical Global Impression-Severity (CGI-S) and Aberrant Behavior Checklist-Withdrawal subscale (ABC-W).

Exclusion Criteria:

• Absence of a parent or legal guardian and consent

• Unavailability for all visits and adherence to study regimen

• Seizure within 2 years of screening

• Impaired renal function (serum creatinine > 1.2 mg/dl), impaired hepatic function (AST/ALT > 2x upper limit of normal), impaired thyroid function (TSH outside normal limits)

• Current infection or treatment with antibiotics; AND

• Chronic medical disorder (e.g., cardiovascular disease, stroke or diabetes) or major surgery within 3 months prior to enrollment.

• A diagnosis of autism spectrum disorder other than autism, for example, Asperger's, PDD-NOS etc.