Diet and Behavior in Young Children With Autism - Tabular View

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Diet and Behavior in Young Children With Autism

This study is ongoing, but not recruiting participants.
Information provided by National Institute of Mental Health (NIMH)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Diet and Behavior in Young Children With Autism

Official Title ^†

Diet and Behavior in Young Children With Autism

Brief Summary

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

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.

Study Phase

Phase I

Study Type ^†

Interventional

Study Design ^†

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

Primary Outcome Measure ^†

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

Secondary Outcome Measure ^†

Condition ^†

Autism
Autistic Disorder

Intervention ^†

Behavioral: Gluten- and casein-free diet
Behavioral: Placebo controlled diet

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

Start Date ^†

January 2004

Completion Date

November 2008

Eligibility 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

Gender

Both

Ages

30 Months to 54 Months

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00090428

Organization ID

U54 MH66397

Secondary IDs ^††

DDTR BD-DD

Study Sponsor ^†

National Institute of Mental Health (NIMH)

Collaborators ^††

Investigators ^†

Principal Investigator:

Susan Hyman, MD

University of Rochester

Information Provided By

National Institute of Mental Health (NIMH)

Verification Date

August 2008

First Received Date ^†

August 26, 2004

Last Updated Date

August 20, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.