Phase 2 N=16 Treatment

Micronutrient Supplementation in Children With ASD

Autism Spectrum Disorder

Bottom Line

View on ClinicalTrials.gov: NCT05268744 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2024

Primary outcome: Primary: Change in the Autism Behavior Inventory, Short Form (ABI-S) — -2.9; -0.8 score on a scale — p=<0.05

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Micronutrient (Drug)
Age: Pediatric, Adult · 5+ yrs
Sex: All
Sponsor: University of California, San Francisco
Primary completion: Jan 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in the Autism Behavior Inventory, Short Form (ABI-S)	-2.9; -0.8	<0.05 sig
PRIMARY Change in the Social Responsiveness Scale (SRS)	-8.1; 0.8	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05268744). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.