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

Autism Clinical Trial

Official title:

Environmental Factors in the Etiology of Autism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00106652
• Other study ID #: 11269-CP-001
• Secondary ID: 200210574-4
• Status: Completed
• Phase: N/A
• First received: March 28, 2005
• Last updated: September 20, 2017
• Start date: September 2001
• Est. completion date: September 2017

Study information

• Verified date: September 2017
• Source: National Institute of Environmental Health Sciences (NIEHS)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 24 Months to 60 Months

Eligibility

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)

Related Conditions & MeSH terms

• Autism
• Autistic Disorder
• Developmental Disabilities

Locations

Country	Name	City	State
United States	University of California	Davis	California

Sponsors (3)

Lead Sponsor	Collaborator
National Institute of Environmental Health Sciences (NIEHS)	University of California, Davis, University of California, Los Angeles

Country where clinical trial is conducted

United States, 

External Links

•   click for more information about this study: Childhood Autism Risks from Genetics and the Environment
•   click here for more information about the UC Davis Center for Children's Environmental Health
•   click here for more information about the UC Davis M.I.N.D. Institute