A Study of Glutathione in Children With Autism Spectrum Disorder

The University of Chicago

Status and phase: Terminated; Phase 4

Conditions: Autism Spectrum Disorder

Treatments: Drug: Glutathione

Study type: Interventional

Funder types: Other

Identifiers

NCT05954052

IRB19-0017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 4 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Boys and girls ages 4-17
• Current diagnosis of Autism Spectrum Disorder as determined by criteria in DSM-5
• Parents of Children ages 4-17 with a current diagnosis of Autism Spectrum Disorder as determined by criteria in DSM-5

Exclusion criteria

• Unstable medical illness or clinically significant abnormalities on physical examination;
• History of seizures;
• History of Hematological disorders;
• Myocardial infarction within 6 months;
• Current pregnancy or lactation, or inadequate contraception in girls of childbearing potential;
• Current or recent (past 3 months) DSM-5 substance abuse or dependence;
• Illegal substance use within 2 weeks of study initiation;
• Previous treatment with Glutathione;
• Current treatment with N-acetylcysteine, milk thistle, Vitamin C, Vitamin B, Grape Seed Extract, Amino Acids, or Zinc
• Current treatment with Dextromethorphan, D-cycloserine, Amantadine, Memantine, Lamotrigine or Riluzole
• Asthma

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Glutathione Oral Supplementation

Experimental group

Description:

Glutathione will be the only study medication dispensed to subjects for this study. Subjects will be told to take the first dose of study medication after breakfast each day and the second dose in the evening after dinner. The proposed dose range for Glutathione in this study will be 1000mg-3000mg/day based on the subject's weight.

Treatment:

Drug: Glutathione