Micronutrient Supplementation in Children With ASD
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|ClinicalTrials.gov Identifier: NCT05268744|
Recruitment Status : Not yet recruiting
First Posted : March 7, 2022
Last Update Posted : May 17, 2022
|Condition or disease||Intervention/treatment||Phase|
|Autism Spectrum Disorder||Drug: Micronutrient||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Micronutrient Supplementation in Children With Autism Spectrum Disorder (ASD): A Clinical Trial Examining Mechanism of Action|
|Estimated Study Start Date :||August 14, 2022|
|Estimated Primary Completion Date :||November 10, 2022|
|Estimated Study Completion Date :||December 8, 2022|
In this open-label trial, all subjects will receive the daily dose of micronutrient, in the form of one lightning stick per day, which contains 2.9 grams of micronutrients per stick. It will be delivered in a powder form taken sublingually.
Subject will take micronutrient supplement daily for 8 weeks
- Correlation between change in the Autism Behavior Inventory, Short Form (ABI-S) and change in metabolites. [ Time Frame: Baseline to Week 8 ]The ABI-S is an observer-reported outcome scale designed specifically to measure change and severity of ASD symptoms. ABI-S will be measured by both parents and teachers. There are 24 questions. The scoring of ABI-S questions can range from 0-3 (with possible reverse scoring) based on scoring instructions for data analysis. Lower score indicates better performance.
- Correlation between change in the Social Responsiveness Scale (SRS) and change in metabolites. [ Time Frame: Baseline to Week 8 ]SRS measures social ability in children and young adults. SRS will be measured by both parents and teachers. There are 65 questions. The scoring of SRS questions can range from 0-3 (with possible reverse scoring) based on scoring instructions for data analysis. The total possible score range for the SRS is 0 - 195. Lower score indicates better performance.
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): NCT05268744
|Contact: Felicia Widjaja, MPHfirstname.lastname@example.org|
|United States, California|
|University of California, San Francisco|
|San Francisco, California, United States, 94143|
|Principal Investigator:||Robert Hendren, DO||University of California, San Francisco|