AutismNCT00106652
Childhood Autism Risks From Genetics and the Environment (The CHARGE Study)
An observational study of Autism and Developmental Disabilities, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 24 to 60 monthsHealthy volunteers can take part
- Conditions the study is for
- Autism, Developmental Disabilities
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2001to Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 60 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Children not meeting eligibility criteria listed above
- Children not residing in selected geographical areas (please contact for more information about specific study locations)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Autism, Developmental Disabilities
- Keywords
- autism, neurodevelopment, neurotoxicology, perinatology, teratology
- Medical subject headings
- Autistic Disorder, Developmental Disabilities
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2005 (estimated)
- Study startSep 2001
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Other
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Sponsor type
- US National Institutes of Health
- Investigators
- Isaac N. Pessah, Ph.D., Principal investigator, University of California, DavisIrva Hertz-Picciotto, Ph.D., Study director, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00106652
- Sponsor's protocol ID
- 11269-CP-001
- Other IDs
- 200210574-4
- Status last verified
- Sep 2017
- First submitted
- 28 Mar 2005
- Last updated
- 25 Sep 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Environmental Factors in the Etiology of Autism
- ClinicalTrials.gov ID
- NCT00106652
- Acronym / sponsor ID
- 11269-CP-001
- Conditions
- Autism, Developmental Disabilities
- Keywords
- autism, neurodevelopment, neurotoxicology, perinatology, teratology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)US National Institutes of Health
- Collaborators
- University of California, Davis, University of California, Los Angeles
- Study start
- Sep 2001
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 29 Mar 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Time perspective
- Other
Who may qualify
- Ages
- 24 to 60 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Children not meeting eligibility criteria listed above
- Children not residing in selected geographical areas (please contact for more information about specific study locations)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2017.
- click for more information about this study: Childhood Autism Risks from Genetics and the EnvironmentLink provided by the sponsor.
- click here for more information about the UC Davis M.I.N.D. InstituteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isaac N. Pessah, Ph.D. principal investigator
University of California, Davis
Irva Hertz-Picciotto, Ph.D. study director
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism and Developmental Disabilities, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2017.