Sulforaphane Treatment of Children with Autism Spectrum Disorder
Technical Report,01 Jul 2016,30 Jun 2017
University of Massachusetts Worcester United States
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This randomized clinical trial seeks to investigate the effect of sulforaphane, an isothiocyanate obtained from 3-day-old broccoli sprouts, on children with autism spectrum disorder ASD. Sulforaphane has several possible modes of action that may benefit ASD through common cellular mechanisms that underlie its heterogeneous phenotypes. The three specific aims of the study are 1 to determine if there are measurable effects on social responsiveness and problem behaviors during treatment with orally administered sulforaphane in 3-12 year old boys and girls with ASD 2 to determine if treatment with sulforaphane is safe and well tolerated and 3 to elucidate cellular biomarkers that support the hypothesized mechanism of action of sulforaphane in ASD. The study design consists of a short Pilot trial, to identify specific biomarkers for further study, and the Main clinical trial, with a double-blind, placebo-controlled, phase-2 crossover design. Outcome measures include analyses of blood and urine samples as well as scores on clinician- and parent-completed behavioral assessments. Analyses and assessments will be done at several specific points over the course of the study. To date, the Pilot trial of 10 children has been completed, and 36 out of the target 50 children for the Main trial have been enrolled. Our plan for the next reporting period is to finish recruiting and enrolling participants in the Main clinical trial and perform data analysis.
- Medicine and Medical Research