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Sulforaphane-rich Broccoli Sprout Extract for Autism

NCT01474993 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2018-09-12

Study results available
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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).

Conditions

Interventions

DRUG

Sulforaphane-rich Broccoli Sprout Extract

30 subjects will be randomly selected to receive sulforaphane-rich Broccoli Sprout Extract. The medication will be supplied and dispensed as No.1 size gelcaps (each gelcap containing \~ 250 mg sulforaphane rich Broccoli Sprout Extract, equivalent to \~ 50 µmol of sulforaphane). The dosage of sulforaphane will depend on subject's body weight: 1. Subjects with body weight less than 101 lbs will receive \~ 50 micromol sulforaphane per day (1 gelcap to be taken once a day) 2. Subjects with body weight 101 lbs to 199 lbs will receive \~ 100 micromol sulforaphane per day (2 gelcaps to be taken once a day) 3. Subjects with bidy weight \> 199 lbs will receive \~ 150 micromol sulforaphane per day (3 gelcaps to be taken once a day)

DRUG

Placebo

15 subjects will be randomly selected to receive inactive placebo (Gelcaps identical in appearance to that of active medication and containing microcrystalline cellulose)

Sponsors & Collaborators

Principal Investigators

  • Andrew W. Zimmerman, M.D. · UMass Medical School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
30 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2013-11-30
Completion
2013-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01474993 on ClinicalTrials.gov