- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00285610
Early Exposure to Lead and Adult Antisocial Outcomes
November 17, 2014 updated by: National Institute of Environmental Health Sciences (NIEHS)
Prior research indicates a link between early lead exposure and risk for delinquent behavior.
In this study, we follow a large birth cohort from the Cincinnati Lead Study into early adulthood to determine whether this increased risk persists.
Outcome measures include official arrest records, diagnoses of Substance Abuse Disorder and Antisocial Personality Disorder, self-report of delinquent behavior, and a psychopathy scale.
Predictors include pre-natal and post-natal blood lead levels.
Multivariate statistical methods will control for potential confounders/covariates.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Anticipated)
225
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
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Ohio
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Cincinnati, Ohio, United States, 45229
- Children's Hospital Medical Center
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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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Pregnant women were recruited from four prenatal clinics in Cincinnati, Ohio if they resided in areas of the city with a high concentration of older, lead-contaminated housing
Description
Inclusion Criteria: (1) Part of original CLS birth cohort -
Exclusion Criteria: (1) Moved out of geographic area
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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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Lead Exposure and Antisocial Behavior
Time Frame: Prenatal (1-2 trimester) and postnatal on a quarterly and bi-annual basis (until 6.5 years)
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Prenatal (1-2 trimester) and postnatal on a quarterly and bi-annual basis (until 6.5 years)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: M. Douglas Ris, Ph.D., Children's Hospital Medical Center, Cincinnati
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
November 1, 2001
Primary Completion (Actual)
October 1, 2006
Study Completion (Actual)
October 1, 2006
Study Registration Dates
First Submitted
February 1, 2006
First Submitted That Met QC Criteria
February 1, 2006
First Posted (Estimate)
February 2, 2006
Study Record Updates
Last Update Posted (Estimate)
November 18, 2014
Last Update Submitted That Met QC Criteria
November 17, 2014
Last Verified
November 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11261-CP-003
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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