Sulforaphane treatment of children with Autism Spectrum Disorder
Abstract
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). Sulforaphanehas 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 all study participants for the Main trial have completed their visits. The plan for the next performance period is to complete the data entry into the electronic database, finish performing the biomarker analysis, perform statistical analysis of the study data, and author and publish the study manuscript.
Document Details
- Document Type
- Technical Report
- Publication Date
- Jul 31, 2018
- Accession Number
- AD1059199
Entities
People
- Andrew W. Zimmerman
Organizations
- University of Massachusetts