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Childhood Autism Risks From Genetics and the Environment (The CHARGE Study)

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. Identifier: NCT00106652
Recruitment Status : Completed
First Posted : March 29, 2005
Last Update Posted : September 25, 2017
University of California, Davis
University of California, Los Angeles
Information provided by:
National Institute of Environmental Health Sciences (NIEHS)

Brief Summary:
The purpose of this study is to understand how genes, environment, and the interplay between the two, influences the development of autism and other neurodevelopmental disorders.

Condition or disease
Autism Developmental Disabilities

Detailed Description:

The causes and contributing factors for autism are poorly understood. Evidence suggests that incidence is increasing, but diagnostic changes and improvements may be playing a role. Both genetic and environmental factors appear to play a role. Autopsy studies demonstrate structural changes in the brain and clinical investigations reveal neurophysiologic differences in information processing in autistic versus normal children. Members of our team recently demonstrated altered levels of certain neuropeptides at birth in children who later developed autism.

This case-control study is the first large-scale epidemiologic investigation of underlying causes for autism and triggers of regression. This study capitalizes on the strengths of the case-control design, which is well suited to examine a broad array of factors for rare conditions that are thought to be multifactorial. Comparisons will be made with both general population controls and mentally retarded children.

The aims are to assess the influence of exogenous exposures, the role of susceptibility factors, and the interplay between these two in the etiology of autism and its phenotypic variation. Chemicals with known or suspected neurodevelopmental toxicity, such as PCB's, certain pesticides, and metals, are being investigated. This study pursues several hypotheses that have recently gained attention, including the combined measles, mumps, rubella vaccine and mercury present in vaccines given during infancy and early childhood. Additionally, biochemical susceptibility is examined through characterization of metabolic, immunologic, and neuronal gene expression profiles and genetic polymorphisms.

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Study Type : Observational
Estimated Enrollment : 2000 participants
Time Perspective: Other
Official Title: Environmental Factors in the Etiology of Autism
Study Start Date : September 2001
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Information from the National Library of Medicine

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Ages Eligible for Study:   24 Months to 60 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Children between 2 and 5 years old
  • Born in California
  • Parents must speak either English or Spanish
  • Children must be living with at least one biologic parent

Exclusion Criteria:

  • Children not meeting eligibility criteria listed above
  • Children not residing in selected geographical areas (please contact for more information about specific study locations)

Information from the National Library of Medicine

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 identifier (NCT number): NCT00106652

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United States, California
University of California
Davis, California, United States, 95616
Sponsors and Collaborators
National Institute of Environmental Health Sciences (NIEHS)
University of California, Davis
University of California, Los Angeles
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Principal Investigator: Isaac N. Pessah, Ph.D. University of California, Davis
Study Director: Irva Hertz-Picciotto, Ph.D. University of California, Davis
Additional Information:
Layout table for additonal information Identifier: NCT00106652    
Other Study ID Numbers: 11269-CP-001
First Posted: March 29, 2005    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: September 2017
Keywords provided by National Institute of Environmental Health Sciences (NIEHS):
Additional relevant MeSH terms:
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Autistic Disorder
Developmental Disabilities
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders