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

NCT00889538 | Completed

• 1 other identifier: Glutathione-KCPCRU-01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Autism; Severe Behavior Disorder

Keywords

Autism; Severe Behavior Disorder; Glutathione; Antioxidants

Outcome Measures

Primary Outcomes (1)

• 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.

  4 months

Secondary Outcomes (3)

• Response to glutathione (changes in behavior) will correlate with the glutathione level (GSH) and GSH:GSSG ratio

  Baseline

• Response to glutathione (changes in behavior) will correlate with the glutathione level (GSH) and GSH:GSSG ratio

  9 weeks

• Response to glutathione (changes in behavior) will correlate with the glutathione level (GSH) and GSH:GSSG ratio

  18 weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR

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

Drug: placebo

Glutathione

ACTIVE COMPARATOR

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

Drug: glutathione

Glutathione, Vit C and NAC

ACTIVE COMPARATOR

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

Drug: glutathione, vit C and NAC

Interventions

placebo DRUG

50 mL of 1/2 normal saline IV

Placebo

glutathione DRUG

glutathione 600 mg IV

Glutathione

glutathione, vit C and NAC DRUG

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

Glutathione, Vit C and NAC

Eligibility Criteria

• Age: 5 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Louisville: lead
• Cumberland Pharmaceuticals: collaborator
• Norton Healthcare: collaborator

Study Sites (1)

KCPCRU

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Autistic Disorder; Mental Disorders

Interventions

Glutathione; Ascorbic Acid

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders

Intervention Hierarchy (Ancestors)

Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Patricia G. Williams, MD

  University of Louisville

  PRINCIPAL INVESTIGATOR

• Janice E. Sullivan, M.D.

  University of Louisville

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2009
• First Posted: April 29, 2009
• Study Start: April 1, 2009
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: December 7, 2016

Record last verified: 2016-12

Locations

US (1)