Lead PoisoningNCT00011674
Early Exposure to Lead and Adolescent Development
An observational study of Lead Poisoning, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
Trial summary
This prospective cohort study examines the role of prenatal and early postnatal lead exposure on the neuropsychological status and social adjustment of adolescents enrolled in the Cincinnati Lead Study. Read more about this study
- Who is it for?
- Ages 0 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lead Poisoning
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- May 1997to May 2001
- 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 0 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Subjects for the Cincinnati Lead Study were recruited prenatally if their mothers resided in areas within Cincinnati, Ohio where there has historically been a high incidence of lead poisoning. Infants were eligible for follow-up if they were greater than 1500 grams at birth and had no disqualifying medical conditions such as defined genetic syndromes or other serious complications that may adversely affect neurobehavioral development.
Trial locations and contacts
1 site in 1 country.
About this study
This prospective cohort study examines the role of prenatal and early postnatal lead exposure on the neuropsychological status and social adjustment of adolescents enrolled in the Cincinnati Lead Study. We are examining the relationship between moderate exposure to lead and neuropsychological deficits, difficulties in peer relationships, personality disturbances and juvenile delinquency. This birth cohort of approximately 300 subjects has been followed since 1980 with regularly scheduled assessments of blood lead concentrations, health history, social and hereditary factors, and neurobehavioral development.
- Conditions
- Lead Poisoning
- Keywords
- Lead, Prenatal, Development, Children, Psychology, Toxicology, Teratology
- Medical subject headings
- Lead Poisoning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2001 (estimated)
- Study startMay 1997
- Study completionMay 2001
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
- Defined population
- Time perspective
- Prospective
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00011674
- Sponsor's protocol ID
- 8158-CP-001
- Status last verified
- Mar 2006
- First submitted
- 26 Feb 2001
- Last updated
- 23 Mar 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Exposure to Lead and Adolescent Development
- ClinicalTrials.gov ID
- NCT00011674
- Acronym / sponsor ID
- 8158-CP-001
- Conditions
- Lead Poisoning
- Keywords
- Lead, Prenatal, Development, Children, Psychology, Toxicology, Teratology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)US National Institutes of Health
- Study start
- May 1997
- Study completion
- May 2001
- First posted
- 28 Feb 2001 (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.
This prospective cohort study examines the role of prenatal and early postnatal lead exposure on the neuropsychological status and social adjustment of adolescents enrolled in the Cincinnati Lead Study. We are examining the relationship between moderate exposure to lead and neuropsychological deficits, difficulties in peer relationships, personality disturbances and juvenile delinquency. This birth cohort of approximately 300 subjects has been followed since 1980 with regularly scheduled assessments of blood lead concentrations, health history, social and hereditary factors, and neurobehavioral development.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
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 23 Mar 2006.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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?
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 23 Mar 2006. 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 23 Mar 2006.