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A Study of Glutathione in Children With Autism Spectrum Disorder
Plain-language guide to NCT05954052: phase 4 interventional trial of Glutathione, 6 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT05954052
- Phase
- phase 4
- Status
- terminated early
- Start
- 2019-07-01
- Completion (planned or actual)
- 2023-08-15
- Participants
- 6 (actual)
- Design
- na, open label (everyone knows who gets what), other
- Conditions studied
- Autism Spectrum Disorder
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
In this phase 4 trial, researchers set out to test Glutathione.
The researchers plan to involve 24 individuals with ASD and give them oral Glutathione for 12 weeks.
It had 1 arm (groups): Glutathione Oral Supplementation (experimental).
The registry classes the interventions as drug.
More on the Plan
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.
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.
Who Took Part
The registry lists 6 actual participants took part.
It was open to people of any sex aged from 4 years up to 17 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: 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.
The full record lists 3 inclusion and 11 exclusion criteria; among the exclusions: history of seizures;; history of hematological disorders;; myocardial infarction within 6 months;.
How the Study Was Run
Design: single-group and open-label.
Being open-label, the Glutathione study did not mask who received what.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2019-07-01 with completion listed for 2023-08-15.
It ran at 1 site in United States.
Its stated primary purpose is other.
What Was Measured
Primary outcome: Aberrant Child Checklist, Looking at Change in the Subscale of the ABC.
It also tracked 1 secondary outcome, for example Social Responsiveness Scale.
What This Means in Plain Language
Put simply, this is a phase 4 trial of Glutathione in 6 people.
Its size is small, so on its own it can only give an early look.
It ended early (terminated); results are posted on the registry, and this page does not restate them.
More context: the Glutathione compound page, all human trials.
Our Notes on the Compound
Glutathione: The body's main antioxidant.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.