Summary

Eligibility
for people ages 5-22 (full criteria)
Location
at San Francisco, California
Dates
study started
estimated completion
Principal Investigator
by Robert Hendren, DO
Headshot of Robert Hendren
Robert Hendren

Description

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.

Official Title

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

Details

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.

Keywords

Autism Spectrum Disorder Micronutrients Trace Elements Micronutrient

Eligibility

You can join if…

Open to people ages 5-22

  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.

You CAN'T join if...

  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

Location

  • University of California, San Francisco
    San Francisco California 94143 United States

Lead Scientist at UCSF

  • Robert Hendren, DO
    Robert L. Hendren, D.O., is Professor of Psychiatry and Behavioral Science; Division of Child and Adolescent Psychiatry; Co-Director of the UCSF Dyslexia Center; and Director, Program for Research on Neurodevelopmental, Translational Outcomes (PRONTO) http://hendrenlab.ucsf.edu . He works in the Center for Autism Spectrum Disorders and Neurodevelopmental Disorders Program.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT05268744
Phase
Phase 2 Autism Research Study
Study Type
Interventional
Participants
Expecting 20 study participants
Last Updated