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Micronutrient Supplementation in Children With ASD

Primary Purpose

Autism Spectrum Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Micronutrient
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder

Eligibility Criteria

5 Years - 22 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California, San Francisco

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Micronutrient

Arm Description

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.

Outcomes

Primary Outcome Measures

Correlation between change in the Autism Behavior Inventory, Short Form (ABI-S) and change in metabolites.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
February 24, 2022
Last Updated
February 1, 2023
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT05268744
Brief Title
Micronutrient Supplementation in Children With ASD
Official Title
Micronutrient Supplementation in Children With Autism Spectrum Disorder (ASD): A Clinical Trial Examining Mechanism of Action
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
November 14, 2022 (Actual)
Primary Completion Date
January 14, 2023 (Actual)
Study Completion Date
January 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Micronutrient
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Micronutrient
Intervention Description
Subject will take micronutrient supplement daily for 8 weeks
Primary Outcome Measure Information:
Title
Correlation between change in the Autism Behavior Inventory, Short Form (ABI-S) and change in metabolites.
Description
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.
Time Frame
Baseline to Week 8
Title
Correlation between change in the Social Responsiveness Scale (SRS) and change in metabolites.
Description
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.
Time Frame
Baseline to Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. Taking multivitamins currently and unwilling to stop during the study period
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Hendren, DO
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Micronutrient Supplementation in Children With ASD

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