Status:
COMPLETED
Sulforaphane-rich Broccoli Sprout Extract for Autism
Lead Sponsor:
Andrew Zimmerman
Collaborating Sponsors:
Johns Hopkins University
Conditions:
Autism
Eligibility:
MALE
13-30 years
Phase:
PHASE2
Brief 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 ...
Detailed Description
Behavioral improvements occur transiently during febrile illnesses in autism, and include decreased repetitive behaviors and improved speech. These changes have been recorded in 38% of autistic childr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT01474993
Start Date
December 1 2011
End Date
November 1 2013
Last Update
September 12 2018
Active Locations (1)
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1
Lurie Center for Autism, MassGeneral Hospital for Children
Lexington, Massachusetts, United States, 02421