Study of Glutathione, Vitamin C and Cysteine in Children With Autism and Severe Behavior Problems

What Was Tested

In this not phased trial, researchers set out to test Glutathione.

It had three arms (groups): Placebo (placebo comparator), Glutathione (active comparator) and Glutathione, Vit C and NAC (active comparator).

Randomized to placebo or treatment (glutathione or glutathione/vit C/NAC).

Randomized to placebo or treatment (glutathione or glutathione/vit C/NAC).

Randomized to placebo or treatment (glutathione or glutathione/vit C/NAC).

The registry classes the interventions as drug.

More on the Plan

This is a prospective, single center, double-blind, randomized pilot study in children and adolescents with autism and severe behavior disorders.

All subjects will undergo initial screening procedures to determine eligibility.

They will then be randomized to either 8 weeks of placebo or 8 weeks of glutathione or glutathione, vitamin C and N-acetylcysteine.

They will receive intravenous treatment weekly and will have ongoing behavioral studies during this period.

Who Took Part

Enrollment: 24 actual participants took part.

It was open to people of any sex aged from 5 years up to 16 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age 5 to 16 years, inclusive. Diagnosed with autism using the ADI-R (Autism Diagnostic Interview-Revised). ABC Irritability/Agitation subscale score (Aberrant Behavior Checklist Subscale) ≥ 18. CGI-S score (Clinical Global Impression-Severity Scale) ≥ 4. Parent/legal guardian must provide written consent and required research authorization (i.e. HIPAA) prior to the performance of any study procedures.

The full record lists 6 inclusion and 9 exclusion criteria; among the exclusions: presence of another disorder on the autism spectrum including pdd-nos (pervasive developmental disorder not otherwise specified), asperger's, and rett's syndrome; patient with a known cause of autism such as fragile x; known hypersensitivity to glutathione, vitamin c or nac.

How the Study Was Run

It was run as a randomized, crossover and quadruple-blind study.

Random assignment meant chance, not the researchers, decided who got Glutathione and who got the comparison, which limits bias.

In the crossover set-up each of the participants took both Glutathione and the comparison in turn, acting as their own control.

As a double-blind Glutathione study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2009-04 with completion listed for 2012-09.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 3 secondary outcomes, for example Response to glutathione (changes in behavior) will correlate with the glutathione level (GSH) and GSH:GSSG ratio, Response to glutathione (changes in behavior) will correlate with the glutathione level (GSH) and GSH:GSSG ratio and Response to glutathione (changes in behavior) will correlate with the glutathione level (GSH) and GSH:GSSG ratio.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Glutathione in 24 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Glutathione compound page, all human trials.