Skip to main content
OpenTrials
Completed

NCT Number: NCT05268744

Micronutrient Supplementation in Children With ASD

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

5 year–22 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of California, San Francisco

San Francisco, California, 94143, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female, enrolled at Oak Hill School (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

Treatment and study plan

Micronutrient

Drug

Subject will take micronutrient supplement daily for 8 weeks

Primary outcomes

  1. Change in the Autism Behavior Inventory, Short Form (ABI-S)

    Time frame: Baseline to Week 8

    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.

  2. Change in the Social Responsiveness Scale (SRS)

    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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 7, 2022
Registry last updated
Feb 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.