- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00106652
Childhood Autism Risks From Genetics and the Environment (The CHARGE Study)
Environmental Factors in the Etiology of Autism
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studieorter
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California
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Davis, California, Förenta staterna, 95616
- University of California
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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)
Studieplan
Hur är studien utformad?
Designdetaljer
- Tidsperspektiv: Övrig
Samarbetspartners och utredare
Utredare
- Huvudutredare: Isaac N. Pessah, Ph.D., University of California, Davis
- Studierektor: Irva Hertz-Picciotto, Ph.D., University of California, Davis
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 11269-CP-001
- 200210574-4
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Kliniska prövningar på Utvecklingsstörning
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Children's Hospital Medical Center, CincinnatiEunice Kennedy Shriver National Institute of Child Health and Human Development...AvslutadBarnutvecklingsstörningar, genomgripandeFörenta staterna