Open Label of Clinical Trial of Sulforaphane in Children With Autism
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02654743|
Recruitment Status : Unknown
Verified October 2016 by University of California, San Francisco.
Recruitment status was: Enrolling by invitation
First Posted : January 13, 2016
Last Update Posted : October 27, 2016
|Condition or disease||Intervention/treatment||Phase|
|Autism||Dietary Supplement: Sulforaphane||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 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|
|Estimated Study Completion Date :||May 2017|
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)
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|