Open Label of Clinical Trial of Sulforaphane in Children With Autism
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|ClinicalTrials.gov Identifier: NCT02654743|
Recruitment Status : Completed
First Posted : January 13, 2016
Last Update Posted : March 6, 2019
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|Condition or disease||Intervention/treatment||Phase|
|Autism||Dietary Supplement: Sulforaphane||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Examination of Changes in Urinary Metabolites With Use of an Antioxidant Supplement, Sulforaphane, in School-aged Children With Autism|
|Study Start Date :||January 2016|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||September 2016|
Sulforaphane (SF) will be administered in an approximate dosage of 1 µmol SF/lb (2.2 kg µmol/kg) body weight. This dosage roughly approximates the dosage that was used in the Singh et al, (2014; PNAS) clinical trial of sulforaphane in male adolescents and adults with autism. The sulforaphane will be supplied as glucoraphanin (GR)-enriched broccoli seed extract tablets (manufacturing details follow). Each active tablet will contain 125 mg broccoli seed extract (containing 37 µmol GR, which is equivalent to about 15 µmol SF), 50 mg dried broccoli sprouts (a source of myrosinase, the enzyme that converts GR to SF), 15 mg ascorbic acid, 55.90 mg microcrystalline cellulose, and other minor GRAS excipients used for tablet forming.
The total dose per day will depend of study participants' body weight.
Dietary Supplement: Sulforaphane
Children with ASD will receive Sulforaphane in this study
- Urinary metabolites [ Time Frame: 3 month ]Urine samples will be analyzed by lab and result will be provided
- Behavior Measures [ Time Frame: 3 months ]Measuring behavior using ABC (Aberrant Behavior Checklist)- self reported 58 questions from 0-3 scale (0-not a problem; 3=severe problem)
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|Ages Eligible for Study:||5 Years to 22 Years (Child, Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Male or female, enrolled at OHS, age 6-22 and with a diagnosis of ASD.
- ASD diagnosis will be established by standard criteria (DSM-IV criteria and expert clinician review of medical records and child observation).
- Written informed consent obtained from the subject's legal representative and ability for subject to comply with the requirements of the study.
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02654743
|Principal Investigator:||Robert Hendren, DO||University of California, San Francisco|
|Responsible Party:||University of California, San Francisco|
|Other Study ID Numbers:||
|First Posted:||January 13, 2016 Key Record Dates|
|Last Update Posted:||March 6, 2019|
|Last Verified:||March 2019|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Physiological Effects of Drugs