Diet and Behavior in Young Children With Autism
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|ClinicalTrials.gov Identifier: NCT00090428|
Recruitment Status : Completed
First Posted : August 27, 2004
Last Update Posted : February 1, 2013
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|Condition or disease||Intervention/treatment||Phase|
|Autism Autistic Disorder||Behavioral: Gluten- and casein-free diet Behavioral: Placebo controlled diet||Phase 1|
Autism is a serious brain disorder that affects brain development and often causes social and educational problems. Prior studies suggested that a gluten- and casein-free diet may have a therapeutic effect on the behavior of children with autism. This study will examine the effects of such a diet on the behavior of children with autism who meet research diagnostic criteria, are monitored in adherence to the diet, and receive similar intense behavioral therapy.
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Diet and Behavior in Young Children With Autism|
|Study Start Date :||January 2004|
|Actual Primary Completion Date :||October 2008|
|Actual Study Completion Date :||February 2009|
Participants will follow a gluten-free and casein-free diet for 18 weeks. The compliance with the diet was monitored with 24 hour dietary recall and nutritional sufficiency with diet diary analysis.
Behavioral: Gluten- and casein-free diet
Participants will follow a gluten-free and casein-free diet for 18 weeks. All children received individual EIBI interventions to decrease the confound of different types of therapies.
Active Comparator: 2
After established on a gluten free and casein free diet for at least 6 weeks, participants received double blind, placebo controlled challenges containing gluten, casein, gluten+casein, or placebo in a random order. Data was collected on behavioral and physiologic responses relative to the challenges. Children remained on the gluten free and casein free diet throughout this period.
Behavioral: Placebo controlled diet
Participants will follow a gluten-free and casein-free diet for 18 weeks. They will receive double blind placebo controlled challenge snacks that contain gluten, casein, gluten+casein or placebo with measurement of response. They remain on the gluten free and casein free diet for the entire study period.
- Safety and efficacy of the gluten free casein free diet [ Time Frame: Measured at Weeks 6,18 and 30 ]Behavioral data: activity, sleep, behaviors related to the autism; Medical data: stool pattern, nutrition
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|Ages Eligible for Study:||30 Months to 54 Months (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Autism spectrum disorder or pervasive developmental disorder, ADI-R and ADOS positive.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00090428
|United States, New York|
|University of Rochester Medical Center|
|Rochester, New York, United States, 14642|
|Principal Investigator:||Susan Hyman, MD||University of Rochester|
|Responsible Party:||susan hyman, Professor, University of Rochester|
|Other Study ID Numbers:||
U54MH066397 ( U.S. NIH Grant/Contract )
U54MH066397 ( U.S. NIH Grant/Contract )
|First Posted:||August 27, 2004 Key Record Dates|
|Last Update Posted:||February 1, 2013|
|Last Verified:||January 2013|
Applied Behavioral Analysis
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Molecular Mechanisms of Pharmacological Action