Micronutrient Supplementation in Children With ASD

Autism Spectrum Disorder Clinical Trial

Official title:

Micronutrient Supplementation in Children With Autism Spectrum Disorder (ASD): A Clinical Trial Examining Mechanism of Action

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05268744
• Other study ID #: 22-35971
• Status: Completed
• Phase: Phase 2
• Start date: November 14, 2022
• Est. completion date: January 30, 2023

Study information

• Verified date: January 2024
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: January 30, 2023
• Est. primary completion date: January 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 22 Years

Eligibility

Inclusion Criteria:

1. Male or female, enrolled at Oak Hill School (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

Related Conditions & MeSH terms

• Autism Spectrum Disorder

Intervention

Drug:
• Micronutrient
Subject will take micronutrient supplement daily for 8 weeks

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the Autism Behavior Inventory, Short Form (ABI-S)	The ABI-S is an observer-reported outcome scale designed specifically to measure change and severity of Autism Spectrum Disorder (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. The total range of score is between 0 and 72. Lower score indicates better performance.	Baseline to Week 8
Primary	Change in the Social Responsiveness Scale (SRS)	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.	Baseline to Week 8