Glutathione for Autism

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a supplement called Glutathione is safe and practical for children and teens with Autism Spectrum Disorder (ASD). Participants will take the supplement orally for 12 weeks, and researchers will observe their responses to the treatment. Children and teens aged 4-17 with a known diagnosis of ASD may be suitable for this trial. As a Phase 4 trial, this research seeks to understand how the already FDA-approved and effective treatment benefits a broader range of patients.

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 is the safety track record for Glutathione?

Research shows that taking glutathione by mouth is generally safe when used in foods and dietary supplements. Studies have confirmed its safety based on current knowledge. Concerns exist about using glutathione in injections, but these do not apply to oral supplements, which this study focuses on. This distinction is important because the trial involves taking glutathione by mouth, not by injection. Therefore, evidence supports the safety of using glutathione as an oral supplement. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatments for Autism Spectrum Disorder, which often focus on behavioral therapies and medications targeting symptoms like irritability and hyperactivity, glutathione is a unique approach because it targets oxidative stress. Researchers are excited about glutathione because it is a powerful antioxidant that may help reduce oxidative damage in the brain, which is thought to play a role in autism. This treatment is administered as an oral supplement, making it potentially easier and more comfortable for children to take compared to other forms of treatment.

What evidence suggests that Glutathione might be an effective treatment for Autism Spectrum Disorder?

Research has shown that oral glutathione supplements effectively raise glutathione levels in the body. Studies have found that daily use of these supplements increases this antioxidant in various body tissues. This is important because glutathione protects cells and supports the immune system. Although no direct evidence yet links it to benefits for Autism Spectrum Disorder (ASD), higher glutathione levels might support overall brain health. Therefore, glutathione could be promising for people with ASD, but more specific research is needed to confirm its benefits for this condition. Participants in this trial will receive glutathione oral supplementation to further investigate its potential effects. ^{5 6 7 8 9}

Who Is on the Research Team?

Karam Radwan, MD

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Glutathione

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6389332/

Oral supplementation with liposomal glutathione elevates ... In a recent clinical trial, we demonstrated that daily oral supplementation of GSH was effective at enhancing GSH levels in oral buccal cells and a variety of ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/24791752/

Randomized controlled trial of oral glutathione ... Conclusions: These findings show, for the first time, that daily consumption of GSH supplements was effective at increasing body compartment stores of GSH.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT01044277

Oral Glutathione Supplementation on the Levels of Blood ... Based on previous laboratory animal studies and clinical data, the investigators anticipate that the effects of oral GSH supplementation will be progressive and ...

4. pure.psu.edu pure.psu.edu/en/publications/randomized-controlled-trial-of-oral-glutathione-supplementation-o

Randomized controlled trial of oral glutathione ... These findings show, for the first time, that daily consumption of GSH supplements was effective at increasing body compartment stores of GSH.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2213231715000841

Effects of N-acetylcysteine, oral glutathione (GSH) and a ... Several studies showed that NAC is well absorbed by the intestine and that a supplementation with NAC is effective for increasing GSH levels [22]. However, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11862975/

Exploring the Safety and Efficacy of Glutathione ... The Philippine Food and Drug Administration (FDA) has issued warnings against IV glutathione, citing risks such as liver damage, severe allergic ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3162377/

Effects of Oral Glutathione Supplementation on Systemic ... Minimal experimental evidence has demonstrated significant increases in blood or intracellular levels of GSH through oral supplementation with reduced GSH.

8. sciencedirect.com sciencedirect.com/science/article/pii/S0278691525000468

Safety assessment of S-Acetyl Glutathione for use in foods ... Overall, based on this safety assessment, the use of SAG in foods and dietary supplements is considered to be safe in the light of current scientific knowledge ...

9. fda.gov fda.gov/drugs/human-drug-compounding/fda-highlights-concerns-using-dietary-ingredient-glutathione-compound-sterile-injectables

FDA highlights concerns with using dietary ingredient ... FDA received a report concerning seven patients who received an injectable drug compounded with L-glutathione and experienced adverse events ...