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Diet and Behavior in Young Children With Autism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00090428
Recruitment Status : Completed
First Posted : August 27, 2004
Last Update Posted : February 1, 2013
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
susan hyman, University of Rochester

Tracking Information
First Submitted Date  ICMJE August 26, 2004
First Posted Date  ICMJE August 27, 2004
Last Update Posted Date February 1, 2013
Study Start Date  ICMJE January 2004
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2013)
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
Original Primary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
Safety and efficacy of the gluten free casein free diet
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Diet and Behavior in Young Children With Autism
Official Title  ICMJE 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. 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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Autism
  • Autistic Disorder
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Gluten- and casein-free diet
  • 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.
    Intervention: Behavioral: Placebo controlled diet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 31, 2013)
21
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
30
Actual Study Completion Date  ICMJE February 2009
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Months to 54 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00090428
Other Study ID Numbers  ICMJE U54MH066397( U.S. NIH Grant/Contract )
U54MH066397 ( U.S. NIH Grant/Contract )
DDTR BD-DD
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party susan hyman, University of Rochester
Study Sponsor  ICMJE University of Rochester
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Susan Hyman, MD University of Rochester
PRS Account University of Rochester
Verification Date January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP