NCT05954052

A Study of Glutathione in Children With Autism Spectrum Disorder

An Open-Label Study of Glutathione in Children With Autism Spectrum Disorder

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 4 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to investigate if taking a supplement called Glutathione by mouth is safe and practical for children and teenagers with Autism Spectrum Disorder (ASD). The researchers plan to involve 24 individuals with ASD and give them oral Glutathione for 12 weeks.

Detailed description

The goal of the proposed study is to evaluate the safety and feasibility of oral Glutathione in children and adolescents who have Autism Spectrum Disorder. Twenty-four subjects with ASD will receive 12 weeks of oral Glutathione reduced. The hypothesis to be tested is that: Oral Glutathione will be effective in increasing the blood level of Glutathione, which may help to decrease some problem behaviors and irritability in this particular ASD population. The second aim of this study is to evaluate the tolerability of oral Glutathione. The proposed study may provide needed data for future studies aimed at the treatment of aggressive behaviors that can be seen in this patient population.

Conditions

• Autism Spectrum Disorder

Interventions

Type	Name	Description
DRUG	Glutathione	Giving supplement orally

Timeline

• Start date: 2019-07-01
• Primary completion: 2023-08-15
• Completion: 2023-08-15
• First posted: 2023-07-20
• Last updated: 2025-09-18
• Results posted: 2025-09-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study