Diet and Behavior in Young Children With Autism - Full Text View

Purpose

This study will determine whether a gluten- and casein-free diet has specific benefits for children with autism.

Condition	Intervention	Phase
Autism Autistic Disorder	Behavioral: Gluten- and casein-free diet Behavioral: Placebo controlled diet	Phase I

Genetics Home Reference related topics:

Autism

MedlinePlus related topics:

Autism

ChemIDplus related topics:

Casein

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	Diet and Behavior in Young Children With Autism

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

Safety and efficacy of the gluten free casein free diet [ Time Frame: Measured at Weeks 18 and 30 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	30
Study Start Date:	January 2004
Estimated Study Completion Date:	November 2008
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Participants will follow a gluten-free and casein-free diet for 18 weeks	Behavioral: Gluten- and casein-free diet Participants will follow a gluten-free and casein-free diet for 18 weeks. They also will be receiving uniform educational and behavioral services through their provider.
2: Active Comparator Participants will follow a placebo controlled gluten-free and casein-free diet diet for 18 weeks	Behavioral: Placebo controlled diet Participants will follow a placebo controlled gluten-free and casein-free diet for 18 weeks.

Detailed Description:

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 following a gluten free and casein free diet for 18 weeks. All subjects will have 6 weeks of baseline followed by 12 weeks of randomized, double-blind, placebo-controlled, challenge snacks with careful behavioral observation and evaluation. They also will be receiving uniform educational and behavioral services through their provider. Standard autism evaluation methods, weekly diet and sleep diaries and scheduled laboratory tests will be used to assess subjects. An end of study, follow-up assessment will be completed at 30 weeks after the start of the study.

Eligibility

Ages Eligible for Study:	30 Months to 54 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Autism spectrum disorder or pervasive developmental disorder
Participation in applied behavioral analysis classes for at least 4 months, with at least 10 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00090428

Locations


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

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators


Principal Investigator:	Susan Hyman, MD	University of Rochester

More Information

Responsible Party:	University of Rochester Medical Center ( Susan Hyman, MD )
Study ID Numbers:	U54 MH66397, DDTR BD-DD
First Received:	August 26, 2004
Last Updated:	April 23, 2008
ClinicalTrials.gov Identifier:	NCT00090428
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Autism

Applied Behavioral Analysis

Gluten

Caseins

Study placed in the following topic categories:

Child Development Disorders, Pervasive

Developmental Disabilities

Caseins

Autistic Disorder

Mental Disorders Diagnosed in Childhood

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action

Mental Disorders

Chelating Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on July 03, 2008

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00090428