A Study of Glutathione in Children With Autism Spectrum Disorder

Age: < 18

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Chicago

Must not be taking: N-acetylcysteine, Vitamin C

Disqualifiers: Seizures, Hematological disorders, Asthma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

6 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, including N-acetylcysteine, milk thistle, Vitamin C, Vitamin B, Grape Seed Extract, Amino Acids, Zinc, Dextromethorphan, D-cycloserine, Amantadine, Memantine, Lamotrigine, or Riluzole before participating.

What data supports the effectiveness of the treatment Glutathione?

Glutathione plays a crucial role in protecting cells from damage by acting as an antioxidant and detoxifying harmful substances. It is involved in various cellular processes, including immune response and cell survival, which can be beneficial in treating conditions related to oxidative stress and detoxification. ^{1 2 3 4 5}

Is Glutathione generally safe for humans?

Glutathione is a natural compound in the body that helps protect cells from damage. Research suggests it is generally safe, but altering its levels can lead to cellular damage, especially if its synthesis is inhibited. It is important to consult with a healthcare provider before using it as a treatment. ^{4 5 6 7 8}

How does the drug Glutathione differ from other treatments for this condition?

Glutathione is unique because it acts as a powerful antioxidant, protecting cells from oxidative stress by maintaining proteins in a reduced state and regulating important cellular processes through reversible modifications. This mechanism of action, involving protein S-glutathionylation, is distinct from many other treatments that may not target oxidative stress or redox signaling pathways as directly. ^{6 9 10 11 12}

What is the purpose of this trial?

This trial is testing if taking a Glutathione supplement by mouth is safe and practical for children and teenagers with Autism Spectrum Disorder (ASD). The goal is to see if it can help reduce problem behaviors and irritability by increasing Glutathione levels in the blood. Recent evidence shows that children with ASD have significantly lower levels of Glutathione than typically developing children.

Research Team

Karam Radwan, MD

Principal Investigator

University of Chicago

Eligibility Criteria

Inclusion Criteria

Boys and girls ages 4-17

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

You have been diagnosed with Autism Spectrum Disorder, based on the criteria in the DSM-5.

Exclusion Criteria

Myocardial infarction within 6 months

Unstable medical illness or clinically significant abnormalities on physical examination

You have previously been treated with Glutathione.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral Glutathione supplementation for 12 weeks to evaluate safety and feasibility in children with ASD

12 weeks

3 visits (in-person) at 4, 8, and 12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Glutathione

Participant Groups

Group I: Glutathione Oral Supplementation Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

References

1. Canada pubmed.ncbi.nlm.nih.gov

Tissue glutathione, nutrition, and oxidative stress. [2019]

2. England pubmed.ncbi.nlm.nih.gov

The role of glutathione in cancer. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Glutathione modulation in cancer treatment: will it work? [2022]

4. England pubmed.ncbi.nlm.nih.gov

Glutathione deficiency produced by inhibition of its synthesis, and its reversal; applications in research and therapy. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Glutathione system in animal model of solid tumors: From regulation to therapeutic target. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Dietary γ-Glutamylcysteine: Its Impact on Glutathione Status and Potential Health Outcomes. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Glutathione and its metabolizing enzymes in patients with different benign and malignant diseases. [2019]

8. Ireland pubmed.ncbi.nlm.nih.gov

Glutathione: an overview of biosynthesis and modulation. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Redox modifications of protein-thiols: emerging roles in cell signaling. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

The antioxidant glutathione. [2023]

11. England pubmed.ncbi.nlm.nih.gov

Novel application of S-nitrosoglutathione-Sepharose to identify proteins that are potential targets for S-nitrosoglutathione-induced mixed-disulphide formation. [2019]

12. England pubmed.ncbi.nlm.nih.gov

Protein S-glutathionylation: from current basics to targeted modifications. [2022]