Sulforaphane in a New Jersey (NJ) Population of Individuals With Autism

• Status: Recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: Male

Summary

This study is a double blind treatment trial that will test if sulforaphane improves core symptoms in autism. The investigators expect to see clinical improvement in some of these areas. Sulforaphanes come from eating certain vegetables such as broccoli. The investigators will be using a preparation that gives specific and reproducible amounts. The investigators will also test specific chemicals and genes needed for sulforaphane usage to try to understand differences in response.

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

Details

• Lead Sponsor: Rutgers, The State University of New Jersey
• Collaborator: Rowan University
• Treatments: Sulforafan; Sulforaphane

Criteria

Inclusion Criteria:

• Autistic disorder diagnosis.

• Age between 13-30 years.

• Male gender.

Exclusion Criteria:

• Absence of a parent or legal guardian and consent,

• Those that can not or will not complete 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 (> 2x upper limit of normal).

• Impaired thyroid function (TSH outside normal limits).

• Current infection or treatment with antibiotics.

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

• Less than 13 years or more than 30 years of age.

• Female gender.

• A diagnosis of autism spectrum disorder other than autistic disorder, for example, Asperger, Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) etc.