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

NCT ID: NCT00889538

Last Updated: 2016-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2012-09-30

Brief Summary

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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

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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.

Conditions

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Autism Severe Behavior Disorder

Keywords

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Autism Severe Behavior Disorder Glutathione Antioxidants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

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

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

50 mL of 1/2 normal saline IV

Glutathione

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

Group Type ACTIVE_COMPARATOR

glutathione

Intervention Type DRUG

glutathione 600 mg IV

Glutathione, Vit C and NAC

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

Group Type ACTIVE_COMPARATOR

glutathione, vit C and NAC

Intervention Type 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

Interventions

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placebo

50 mL of 1/2 normal saline IV

Intervention Type DRUG

glutathione

glutathione 600 mg IV

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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NAC

Eligibility Criteria

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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.
Minimum Eligible Age

5 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cumberland Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Norton Healthcare

OTHER

Sponsor Role collaborator

University of Louisville

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Patricia G. Williams, MD

Role: PRINCIPAL_INVESTIGATOR

University of Louisville

Janice E. Sullivan, M.D.

Role: STUDY_DIRECTOR

University of Louisville

Locations

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KCPCRU

Louisville, Kentucky, United States

Site Status

Countries

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United States

Other Identifiers

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Glutathione-KCPCRU-01

Identifier Type: -

Identifier Source: org_study_id