Attention Deficit DisorderNCT00014898
Attention Deficit Disorder and Exposure to Lead
An observational study of Attention Deficit Disorder, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
Trial summary
We are examining the past exposure to lead in 250 well characterized children with ADHD, and a suitable group of controls. Our measure of past exposure is bone lead levels obtained by XRay fluorescence spectroscopy, a relatively new way of estimating bone lead concentrations, and by inference, body lead burdens. Read more about this study
- Who is it for?
- Ages 10 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Disorder
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 1999to May 2002
- 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 10 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Case subjects are drawn from adolescents aged 10 to 18 previously seen at Western Psychiatric Institute and Clinic for evaluation, and meet the DSM-IIIR criteria for diagnosis of ADHD based on a structured parent interview and standardized parent and teacher rating scales. Cases were also systematically observed and evaluated in the summer treatment program between 1987 and 1996 at WPIC. Controls are demographically matched non-ADHD adolescents, recruited from surrounding communities and pediatric practices.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
We are examining the past exposure to lead in 250 well characterized children with ADHD, and a suitable group of controls. Our measure of past exposure is bone lead levels obtained by XRay fluorescence spectroscopy, a relatively new way of estimating bone lead concentrations, and by inference, body lead burdens. By comparing the lead concentrations in these two groups, controlling for other factors which could confound, we will estimate odds ratios for ADHD given elevated bone lead, and estimate the contribution of lead to this disease of childhood.
- Conditions
- Attention Deficit Disorder
- Keywords
- Lead exposure, Bone lead, Attention deficit
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2001 (estimated)
- Study startJun 1999
- Study completionMay 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit DisorderStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 500 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
- NCT00014898
- Sponsor's protocol ID
- 5015-CP-001
- Status last verified
- Mar 2001
- First submitted
- 12 Apr 2001
- 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
- Attention Deficit Disorder and Exposure to Lead
- ClinicalTrials.gov ID
- NCT00014898
- Acronym / sponsor ID
- 5015-CP-001
- Conditions
- Attention Deficit Disorder
- Keywords
- Lead exposure, Bone lead, Attention deficit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)US National Institutes of Health
- Study start
- Jun 1999
- Study completion
- May 2002
- First posted
- 13 Apr 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.
We are examining the past exposure to lead in 250 well characterized children with ADHD, and a suitable group of controls. Our measure of past exposure is bone lead levels obtained by XRay fluorescence spectroscopy, a relatively new way of estimating bone lead concentrations, and by inference, body lead burdens. By comparing the lead concentrations in these two groups, controlling for other factors which could confound, we will estimate odds ratios for ADHD given elevated bone lead, and estimate the contribution of lead to this disease of childhood.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, 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 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 Attention Deficit Disorder, 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 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.