Lead PoisoningNCT00285610
Early Exposure to Lead and Adult Antisocial Outcomes
An observational study of Lead Poisoning, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lead Poisoning
- How many people
- 225 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2001to Oct 2006
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
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.
- Conditions
- Lead Poisoning
- Medical subject headings
- Lead Poisoning
What is being measured
The primary outcome is the main question the study is designed to answer.
Lead Exposure and Antisocial Behavior
Measured: Prenatal (1-2 trimester) and postnatal on a quarterly and bi-annual basis (until 6.5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2006 (estimated)
- Study startNov 2001
- Primary completionOct 2006
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lead PoisoningStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- M. Douglas Ris, Ph.D., Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00285610
- Sponsor's protocol ID
- 11261-CP-003
- Status last verified
- Nov 2014
- First submitted
- 1 Feb 2006
- Last updated
- 18 Nov 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Exposure to Lead and Adult Antisocial Outcomes
- ClinicalTrials.gov ID
- NCT00285610
- Acronym / sponsor ID
- 11261-CP-003
- Conditions
- Lead Poisoning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)US National Institutes of Health
- Study start
- Nov 2001
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 2 Feb 2006 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
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
Lead Exposure and Antisocial Behavior
Time frame: Prenatal (1-2 trimester) and postnatal on a quarterly and bi-annual basis (until 6.5 years)
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 18 Nov 2014.
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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.
M. Douglas Ris, Ph.D. principal investigator
Children's Hospital Medical Center, Cincinnati
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 Lead Poisoning, 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 0 inclusion and 1 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 18 Nov 2014. 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.
What does the primary outcome measure?
Lead Exposure and Antisocial Behavior (time frame: Prenatal (1-2 trimester) and postnatal on a quarterly and bi-annual basis (until 6.5 years)). It is what the study was designed to measure, not a finding.
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 18 Nov 2014.