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

NCT00889538 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2016-12-07

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Cumberland Pharmaceuticals

    collaborator INDUSTRY

  • Norton Healthcare

    collaborator OTHER

  • University of Louisville

    lead OTHER

Principal Investigators

  • Patricia G. Williams, MD · University of Louisville

  • Janice E. Sullivan, M.D. · University of Louisville

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
5 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00889538 on ClinicalTrials.gov