NCT00285610

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
225

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2001

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2001

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

February 1, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 2, 2006

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

November 18, 2014

Status Verified

November 1, 2014

Enrollment Period

4.9 years

First QC Date

February 1, 2006

Last Update Submit

November 17, 2014

Conditions

Lead Poisoning

Outcome Measures

Primary Outcomes (1)

  • Lead Exposure and Antisocial Behavior

    Prenatal (1-2 trimester) and postnatal on a quarterly and bi-annual basis (until 6.5 years)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Lead Poisoning

Condition Hierarchy (Ancestors)

Heavy Metal PoisoningPoisoningChemically-Induced Disorders

Study Officials

  • M. Douglas Ris, Ph.D.

    Children's Hospital Medical Center, Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2006

First Posted

February 2, 2006

Study Start

November 1, 2001

Primary Completion

October 1, 2006

Study Completion

October 1, 2006

Last Updated

November 18, 2014

Record last verified: 2014-11

Locations

US(1)