NCT05268744

Micronutrient Supplementation in Children With ASD

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 5 Years – 22 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Autism Spectrum Disorder

Interventions

Type	Name	Description
DRUG	Micronutrient	Subject will take micronutrient supplement daily for 8 weeks

Timeline

• Start date: 2022-11-14
• Primary completion: 2023-01-14
• Completion: 2023-01-30
• First posted: 2022-03-07
• Last updated: 2024-02-29
• Results posted: 2024-02-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study