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Diet and Behavior in Young Children with Autism - Article


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Autism and Communication


Clinical Trial: Diet and Behavior in Young Children with Autism

This study is currently recruiting patients.

Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)

Purpose

The purpose of this study is to determine whether a gluten- and casein-free diet has specific benefits for children with autism.

Condition Treatment or Intervention Phase
Autism
 Behavior: Gluten- and casein-free diet
Phase I

MedlinePlus related topics:  Autism

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further Study Details: 
Primary Outcomes: Safety and Efficacy of the gluten free casein free diet
Expected Total Enrollment:  30

Study start: January 2004;  Expected completion: April 2008
Last follow-up: April 2008;  Data entry closure: April 2008

Autism is a serious brain disorder that affects brain development and often causes social and educational problems. Studies suggest that a gluten- and casein-free diet may have a therapeutic effect on children with autism. This study will examine the effects of such a diet in autistic children.

Children in this study will be randomly assigned to follow either a gluten- and casein-free diet or a standard diet for 16 weeks. All participants will receive a supplement regimen, and educational and behavioral services will be provided. Standard autism evaluation methods, weekly diet and sleep diaries, and laboratory tests will be used to assess participants. A follow-up assessment will be completed 30 weeks after the start of the study.

Eligibility

Ages Eligible for Study:  30 Months   -   54 Months,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

  • Autism spectrum disorder or pervasive developmental disorder
  • Participation in applied behavioral analysis classes for at least 4 months, with at least 20 hours per week of service, and at least 1 hour of service in the home
  • A score higher than 30 on the Mullen Early Learning scale
  • Ability to maintain a gluten- and casein-free diet during the study
  • In order to maintain study integrity, and due to frequent child assessments, enrollment is limited to a select population within the Rochester area

Location and Contact Information


New York
      University of Rochester Medical Center, Rochester,  New York,  14642,  United States; Recruiting
Carol Stamm   carol_stamm@urmc.rochester.edu 

Study chairs or principal investigators

Susan Hyman, MD,  Principal Investigator,  University of Rochester   

More Information

Study ID Numbers:  1U54MH066397-01A1
Record last reviewed:  October 2004
Last Updated:  October 20, 2004
Record first received:  August 26, 2004
ClinicalTrials.gov Identifier:  NCT00090428
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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July 25, 2008



Page Updated: September 6, 2005
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