An interventional study of placebo and glutathione in Autism and Severe Behavior Disorder, sponsored by University of Louisville. Completed at 1 site in United States. Open to participants aged 5 Years to 16 Years. Per ClinicalTrials.gov, last updated 2016-12-07.
Sponsored by University of Louisville · Not applicable, Interventional, and Treatment
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. The investigators 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.
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.
1,344 studies on the registry are indexed under Autistic Disorder; 334 are open to participants now.
This study's enrollment of 24 is below the median of 45 across 1,044 interventional studies indexed under Autistic Disorder.
Browse Autistic Disorder studies →University of Louisville is the lead sponsor of 284 studies on the registry; 53 are open to participants now.
Of its 20 completed or terminated interventional studies of FDA-regulated products, 7 (35%) have results posted.
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Exclusion Criteria:
Randomized to placebo or treatment (glutathione or glutathione/vit C/NAC)
Drug: placebo
Randomized to placebo or treatment (glutathione or glutathione/vit C/NAC)
Drug: glutathione
Randomized to placebo or treatment (glutathione or glutathione/vit C/NAC)
Drug: glutathione, vit C and NAC
50 mL of 1/2 normal saline IV
glutathione 600 mg IV
Glutathione 600 mg IV Vitamin C 2000 mg IV N-acetylcysteine 20 mg/kg IV (max dose = 600 mg) Mix above three in 1/2 NS for a total volume of 50 mL
Also known as: NAC
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.
Improvement in both developmental skills and behavior measured using validated scales in subjects receiving either glutathione, glutathione/Vitamin C/N-acetylcysteine or placebo measured at baseline, 9 weeks and at the end of study in a double-blind cross-over design.
Time frame: 4 months
Response to glutathione (changes in behavior) will correlate with the glutathione level (GSH) and GSH:GSSG ratio
Time frame: Baseline
Response to glutathione (changes in behavior) will correlate with the glutathione level (GSH) and GSH:GSSG ratio
Time frame: 9 weeks
Response to glutathione (changes in behavior) will correlate with the glutathione level (GSH) and GSH:GSSG ratio
Time frame: 18 weeks
This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.
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University of Louisville