Double-Blind Study of Glutathione, Vitamin C and Cysteine in Children With Autism and Severe Behavior Problems
http://localclinicaltrials.com/NCT00889538/Double-Blind-Study-of-Glutathione,-Vitam.html?ref=twitter&q=Autism
Summary
This is a double-blind, placebo-controlled crossover study to evaluate the safety and efficacy of glutathione alone or glutathione, vitamin C and NAC treatment in children with autism who also have severe behavior problems.
Our hypothesis is that children with autism will show improvement in both learning capabilities and behavior with either glutathione, or glutathione, vitamin C and NAC therapy.
Condition / Disease
Autism
Severe Behavior Disorder
Therapy
placebo
glutathione
glutathione, vitamin C and N-acetylcysteine
Study Outcomes
Improvement in both developmental skills and behavior with either glutathione or glutathione, Vitamin C and N-acetylcysteine therapy as compared to placebo therapy. Subjects will also be monitored using clinical and laboratory safety parameters.
Response to glutathione (changes in behavior) will correlate with the glutathione level (GSH) and GSH:GSSG ratio
Description
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. Following 8 weeks of therapy, they will have a week without treatment then will cross-over to the alternate therapy for weekly intravenous infusions and behavioral testing. In addition to baseline hematology and chemistries, baseline oxidized and reduced glutathione will be measured. These parameters will be repeated at the end of each 8 week course of therapy.