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

Primary Purpose

Autism, Severe Behavior Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
placebo
glutathione
glutathione, vit C and NAC
Sponsored by
University of Louisville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism focused on measuring Autism, Severe Behavior Disorder, Glutathione, Antioxidants

Eligibility Criteria

5 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • KCPCRU

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Placebo

Glutathione

Glutathione, Vit C and NAC

Arm Description

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)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
April 28, 2009
Last Updated
December 6, 2016
Sponsor
University of Louisville
Collaborators
Cumberland Pharmaceuticals, Norton Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT00889538
Brief Title
Study of Glutathione, Vitamin C and Cysteine in Children With Autism and Severe Behavior Problems
Official Title
Double-Blind, Placebo-Controlled, Crossover Study of Glutathione, Vitamin C and Cysteine in Children With Autism and Severe Behavior Problems
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Louisville
Collaborators
Cumberland Pharmaceuticals, Norton Healthcare

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism, Severe Behavior Disorder
Keywords
Autism, Severe Behavior Disorder, Glutathione, Antioxidants

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Randomized to placebo or treatment (glutathione or glutathione/vit C/NAC)
Arm Title
Glutathione
Arm Type
Active Comparator
Arm Description
Randomized to placebo or treatment (glutathione or glutathione/vit C/NAC)
Arm Title
Glutathione, Vit C and NAC
Arm Type
Active Comparator
Arm Description
Randomized to placebo or treatment (glutathione or glutathione/vit C/NAC)
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
50 mL of 1/2 normal saline IV
Intervention Type
Drug
Intervention Name(s)
glutathione
Intervention Description
glutathione 600 mg IV
Intervention Type
Drug
Intervention Name(s)
glutathione, vit C and NAC
Other Intervention Name(s)
NAC
Intervention Description
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
Primary Outcome Measure Information:
Title
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.
Description
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
Secondary Outcome Measure Information:
Title
Response to glutathione (changes in behavior) will correlate with the glutathione level (GSH) and GSH:GSSG ratio
Time Frame
Baseline
Title
Response to glutathione (changes in behavior) will correlate with the glutathione level (GSH) and GSH:GSSG ratio
Time Frame
9 weeks
Title
Response to glutathione (changes in behavior) will correlate with the glutathione level (GSH) and GSH:GSSG ratio
Time Frame
18 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia G. Williams, MD
Organizational Affiliation
University of Louisville
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Janice E. Sullivan, M.D.
Organizational Affiliation
University of Louisville
Official's Role
Study Director
Facility Information:
Facility Name
KCPCRU
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States

12. IPD Sharing Statement

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

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