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Trial record 1 of 1 for:    NCT00090428
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Diet and Behavior in Young Children With Autism

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
susan hyman, University of Rochester
ClinicalTrials.gov Identifier:
NCT00090428
First received: August 26, 2004
Last updated: January 31, 2013
Last verified: January 2013
History of Changes
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Diet and Behavior in Young Children With Autism

Resource links provided by NLM:

MedlinePlus related topics: Autism
Drug Information available for: Casein
U.S. FDA Resources

Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Safety and efficacy of the gluten free casein free diet [ Time Frame: Measured at Weeks 6,18 and 30 ] [ Designated as safety issue: Yes ]
    Behavioral data: activity, sleep, behaviors related to the autism; Medical data: stool pattern, nutrition


Enrollment: 21
Study Start Date: January 2004
Study Completion Date: February 2009
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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.

Detailed Description:

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.

  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, 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00090428

Locations
United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Susan Hyman, MD University of Rochester
  More Information

No publications provided

Responsible Party: susan hyman, Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT00090428     History of Changes
Other Study ID Numbers: U54 MH66397, U54MH066397, DDTR BD-DD
Study First Received: August 26, 2004
Last Updated: January 31, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Rochester:
Autism
Applied Behavioral Analysis
Gluten
Casein

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders
 Caseins
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013