Lead PoisoningNCT00000104
Does Lead Burden Alter Neuropsychological Development?
An observational study of Lead Poisoning, run by National Center for Research Resources (NCRR) at 1 site in United States.
Trial summary
Inner city children are at an increased risk for lead overburden. This in turn affects cognitive functioning. However, the underlying neuropsychological effects of lead overburden and its age-specific effects have not been well delineated. Read more about this study
- Who is it for?
- Ages 0 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lead Poisoning
- What is being tested?
- ERP measures of attention and memory
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- 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
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Pregnant mothers of the Phillips neighborhood in Minneapolis, Minnesota. Subject recruitment will take place in local clinics which serve pregnant women and offspring
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Neurology 420 Delaware St. SE, Box 486 Mayo
Minneapolis, Minnesota, 55455
About this study
Inner city children are at an increased risk for lead overburden. This in turn affects cognitive functioning. However, the underlying neuropsychological effects of lead overburden and its age-specific effects have not been well delineated. This study is part of a larger study on the effects of lead overburden on the development of attention and memory. The larger study is using a multi-model approach to study the effects of lead overburden on these effects including the event-related potential (ERP), electrophysiologic measures of attention and memory are studied. Every eight months, for a total of three sessions the subjects will complete ERP measures of attention and memory which require them to watch various computer images while wearing scalp electrodes recording from 11 sites. It is this test that we are going to be doing on CRC. There will be 30 lead overburdened children recruited from the larger study for participation in the ERP studies on CRC. These 30 children will be matched with 30 children without lead overburden. This portion of the study is important in providing an index of physiological functioning to be used along with behaviorally based measures of attention and memory, and for providing information about the different measures.
- Conditions
- Lead Poisoning
- Being tested
- ERP measures of attention and memory
- Keywords
- lead overburden
- Medical subject headings
- Lead Poisoning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERP measures of attention and memoryProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
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
- Other
Sponsor and investigators
- Lead sponsor
- National Center for Research Resources (NCRR)
- Sponsor type
- US National Institutes of Health
- Collaborators
- HRSA/Maternal and Child Health Bureau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000104
- Sponsor's protocol ID
- NCRR-M01RR00400-0587
- Other IDs
- M01RR000400
- Status last verified
- Dec 2003
- First submitted
- 3 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Lead Burden Alter Neuropsychological Development?
- ClinicalTrials.gov ID
- NCT00000104
- Acronym / sponsor ID
- NCRR-M01RR00400-0587
- Conditions
- Lead Poisoning
- Keywords
- lead overburden
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Center for Research Resources (NCRR)US National Institutes of Health
- Collaborators
- HRSA/Maternal and Child Health Bureau
- First posted
- 4 Nov 1999 (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.
Inner city children are at an increased risk for lead overburden. This in turn affects cognitive functioning. However, the underlying neuropsychological effects of lead overburden and its age-specific effects have not been well delineated. This study is part of a larger study on the effects of lead overburden on the development of attention and memory. The larger study is using a multi-model approach to study the effects of lead overburden on these effects including the event-related potential (ERP), electrophysiologic measures of attention and memory are studied. Every eight months, for a total of three sessions the subjects will complete ERP measures of attention and memory which require them to watch various computer images while wearing scalp electrodes recording from 11 sites. It is this test that we are going to be doing on CRC. There will be 30 lead overburdened children recruited from the larger study for participation in the ERP studies on CRC. These 30 children will be matched with 30 children without lead overburden. This portion of the study is important in providing an index of physiological functioning to be used along with behaviorally based measures of attention and memory, and for providing information about the different measures.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 0 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Pregnant mothers of the Phillips neighborhood in Minneapolis, Minnesota. Subject recruitment will take place in local clinics which serve pregnant women and offspring
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ERP measures of attention and memory | Procedure or surgery | – |
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 24 Jun 2005.
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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 Center for Research Resources (NCRR) 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 1 inclusion and 0 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 24 Jun 2005. 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 24 Jun 2005.