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

Sponsor

National Institute of Environmental Health Sciences (NIEHS) (NIH)

Overall Status

Completed

CT.gov ID

NCT00106652

Collaborator

University of California, Davis (Other), University of California, Los Angeles (Other)

2,000

Enrollment

Location

192

Duration (Months)

10.4

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

2000 participants

Time Perspective:

Other

Official Title:

Environmental Factors in the Etiology of Autism

Study Start Date :

Sep 1, 2001

Actual Primary Completion Date :

Sep 1, 2017

Actual Study Completion Date :

Sep 1, 2017

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

24 Months to 60 Months

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)