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

This study has been completed.
Sponsor:
Collaborators:
Kosair Children's Hospital Foundation
Cumberland Pharmaceuticals
Information provided by (Responsible Party):
University of Louisville
ClinicalTrials.gov Identifier:
NCT00889538
First received: April 28, 2009
Last updated: May 23, 2013
Last verified: May 2013

April 28, 2009
May 23, 2013
April 2009
September 2012   (final data collection date for primary outcome measure)
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. [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
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.
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. [ Time Frame: Baseline, 9 and 18 weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00889538 on ClinicalTrials.gov Archive Site
  • Response to glutathione (changes in behavior) will correlate with the glutathione level (GSH) and GSH:GSSG ratio [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Response to glutathione (changes in behavior) will correlate with the glutathione level (GSH) and GSH:GSSG ratio [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
  • Response to glutathione (changes in behavior) will correlate with the glutathione level (GSH) and GSH:GSSG ratio [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
Response to glutathione (changes in behavior) will correlate with the glutathione level (GSH) and GSH:GSSG ratio [ Time Frame: Baseline, 9 and 18 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study of Glutathione, Vitamin C and Cysteine in Children With Autism and Severe Behavior Problems
Double-Blind, Placebo-Controlled, Crossover Study of Glutathione, Vitamin C and Cysteine in Children With Autism and Severe Behavior Problems

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Autism
  • Severe Behavior Disorder
  • Drug: placebo
    50 mL of 1/2 normal saline IV
  • Drug: glutathione
    glutathione 600 mg IV
  • Drug: glutathione, vit C and NAC
    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
    Other Name: NAC
  • Placebo Comparator: Placebo
    Randomized to placebo or treatment (glutathione or glutathione/vit C/NAC)
    Intervention: Drug: placebo
  • Active Comparator: Glutathione
    Randomized to placebo or treatment (glutathione or glutathione/vit C/NAC)
    Intervention: Drug: glutathione
  • Active Comparator: Glutathione, Vit C and NAC
    Randomized to placebo or treatment (glutathione or glutathione/vit C/NAC)
    Intervention: Drug: glutathione, vit C and NAC
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
September 2012
September 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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
  • Must be drug naïve or on a stable dose of medication(s) and educational/behavioral interventions for one month prior to participation
  • Parent/legal guardian must provide written consent and required research authorization (i.e. HIPAA) prior to the performance of any study procedures.

Exclusion Criteria:

  • 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
  • Evidence of significant renal dysfunction (e.g. GFR estimated by the Schwartz formula < 50 mL/min or serum creatinine > 2.5 X upper limit of normal for age)
  • Evidence of significant hepatic dysfunction (serum transaminases > 2.5 X the upper limit of normal)
  • Known hypersensitivity to glutathione, vitamin C or NAC
  • Pregnant or lactating female
  • Inability of subject and parent to be able to comply with requirements for study visits and procedures
  • Presence of major mental illness
  • History of antioxidant supplementation.
Both
5 Years to 16 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00889538
Glutathione-KCPCRU-01
No
University of Louisville
University of Louisville
  • Kosair Children's Hospital Foundation
  • Cumberland Pharmaceuticals
Principal Investigator: Patricia G. Williams, MD University of Louisville
Study Director: Janice E. Sullivan, M.D. University of Louisville
University of Louisville
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP