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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
Sponsor:
Information provided by (Responsible Party):
Robert Hendren, University of California, San Francisco

Brief Summary:
An open-label examination of changes in metabolites with use of micronutrients in children with autism spectrum disorder (ASD). Investigators will also measure behavioral measures monthly at school with teachers and parents report.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Drug: Micronutrient Phase 2

Detailed Description:
Children enrolled in Oak Hill School will enroll in this study and take micronutrient supplement once a day for 8 weeks period. Behavioral measures and metabolites taken from Dried Blood Spots (DBS) will be collected pre and post treatment. Behavioral measures will be taken again at 12 weeks, after 4 weeks of not dosing.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Micronutrient
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.
Drug: Micronutrient
Subject will take micronutrient supplement daily for 8 weeks




Primary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 22 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female, enrolled at OHS, age 6-22 and with a diagnosis of ASD.
  2. ASD diagnosis will be established by standard criteria (DSM-IV criteria and expert clinician review of medical records and child observation).
  3. Written informed consent obtained from the subject's legal representative and ability for subject to comply with the requirements of the study.

Exclusion Criteria:

  1. 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.
  2. Taking multivitamins currently and unwilling to stop during the study period

Information from the National Library of Medicine

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


Contacts
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Contact: Felicia Widjaja, MPH 415-476-7803 felicia.widjaja@ucsf.edu

Locations
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United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Robert Hendren, DO University of California, San Francisco
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Responsible Party: Robert Hendren, Professor, Psychiatry, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT05268744    
Other Study ID Numbers: 22-35971
First Posted: March 7, 2022    Key Record Dates
Last Update Posted: May 17, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Micronutrients
Trace Elements
Physiological Effects of Drugs