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

September 20, 2017 updated by: National Institute of Environmental Health Sciences (NIEHS)

Environmental Factors in the Etiology of Autism

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Davis, California, United States, 95616
        • University of California

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Other

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Environmental Health Sciences (NIEHS)

Collaborators

University of California, Los Angeles
University of California, Davis

Investigators

  • Principal Investigator: Isaac N. Pessah, Ph.D., University of California, Davis
  • Study Director: Irva Hertz-Picciotto, Ph.D., University of California, Davis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2001

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

March 28, 2005

First Submitted That Met QC Criteria

March 28, 2005

First Posted (Estimate)

March 29, 2005

Study Record Updates

Last Update Posted (Actual)

September 25, 2017

Last Update Submitted That Met QC Criteria

September 20, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11269-CP-001
  • 200210574-4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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