Poisoning, LeadNCT00285532
Identifying Residential Hazards Using Home Test Kits
An observational study of Poisoning, Lead, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
Trial summary
The purpose of this project is to help families and communities identify and reduce health risks from lead, pesticides and, ultimately, other environmental hazards. We have partnered with the Better Housing League and Baby's Milk Fund in Cincinnati and nationally with the Alliance to End Childhood Lead Poisoning and… Read more about this study
- Who is it for?
- Ages 3 months to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Poisoning, Lead
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 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 3 months to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children <5 years receiving care via Babies Milk Fund Clinics
Who may be able to join
- Venous blood lead In residence 3 months Child less than 5 years of age Sampler greater than 18 years of age
Who cannot join
- Cannot read or understand English Physically unable to conduct field sampling Outside of theGreater Cincinnati area
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Cincinnati
Cincinnati, Ohio, 45267-0056
About this study
The purpose of this project is to help families and communities identify and reduce health risks from lead, pesticides and, ultimately, other environmental hazards. We have partnered with the Better Housing League and Baby's Milk Fund in Cincinnati and nationally with the Alliance to End Childhood Lead Poisoning and the National Center for Lead Safe Housing. The first specific aim of this project is to evaluate a sampling kit for families to assess levels of lead and pesticides in their home environment. This aim will strengthen right-to-know laws by providing families with tools to assess environmental contamination in their own homes. The second aim is to increase community awareness of the role of environmental agents in developmental disorders, hearing loss and school problems.
Read the detailed description
A cross-sectional random, stratified study design will be used for this project. All children who are younger than 5 years of age and have a venipuncture blood sample taken at the babies Milk Fund Clinic will be eligible for this study. After checking the lists for errors and duplications, we will randomly permute the sampling frame, stratifying on children's blood lead concentration. Stratification will be used to enroll about 33% of the sample with blood lead concentrations below 5 mg/dl, 33% between 5 to 10 mg/dl, and 33% of 10 mg/dl or higher. Stratifying the sample will improve our chances of testing the predictive validity of home sampling kits to identify children who have blood lead concentration > 10 mg/dl collected by families. In addition this study will:
- Develop a pesticide wipe sampling kit to accompany our lead-sampling kit.
- Evaluate the predictive validity of home sampling kits for lead-contaminated floor dust to identify children who have blood lead levels of 10 mg/dl or higher by community participants compared with repeat samples taken by trained, community workers.
- Evaluate the reliability of home sampling kits for pesticides in dust collected by community participants compared with trained, community workers.
- Disseminate data on the reliability of home sampling tests and provide tools for families to collect environmental samples for large, population-based studies.
- Develop a Healthy Homes Resource Center at the Better Housing League to disseminate information to the community about residential hazards.
- Conditions
- Poisoning, Lead
- Keywords
- Blood Lead, Pesticides, Community-based, Sampling Kits
- Medical subject headings
- Lead Poisoning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Home test kit | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lead and Pesticide Levels
Measured: One time home visit 3-5 days after distribution of kits
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 startOct 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 Poisoning, LeadStudies 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
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Sponsor type
- US National Institutes of Health
- Investigators
- Sandy M Roda, BS, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00285532
- Sponsor's protocol ID
- 11261-CP-002
- 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
- Identifying Residential Hazards Using Home Test Kits
- ClinicalTrials.gov ID
- NCT00285532
- Acronym / sponsor ID
- 11261-CP-002
- Conditions
- Poisoning, Lead
- Keywords
- Blood Lead, Pesticides, Community-based, Sampling Kits
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)US National Institutes of Health
- Study start
- Oct 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.
The purpose of this project is to help families and communities identify and reduce health risks from lead, pesticides and, ultimately, other environmental hazards. We have partnered with the Better Housing League and Baby's Milk Fund in Cincinnati and nationally with the Alliance to End Childhood Lead Poisoning and the National Center for Lead Safe Housing. The first specific aim of this project is to evaluate a sampling kit for families to assess levels of lead and pesticides in their home environment. This aim will strengthen right-to-know laws by providing families with tools to assess environmental contamination in their own homes. The second aim is to increase community awareness of the role of environmental agents in developmental disorders, hearing loss and school problems.
Detailed description
A cross-sectional random, stratified study design will be used for this project. All children who are younger than 5 years of age and have a venipuncture blood sample taken at the babies Milk Fund Clinic will be eligible for this study. After checking the lists for errors and duplications, we will randomly permute the sampling frame, stratifying on children's blood lead concentration. Stratification will be used to enroll about 33% of the sample with blood lead concentrations below 5 mg/dl, 33% between 5 to 10 mg/dl, and 33% of 10 mg/dl or higher. Stratifying the sample will improve our chances of testing the predictive validity of home sampling kits to identify children who have blood lead concentration > 10 mg/dl collected by families. In addition this study will:
- Develop a pesticide wipe sampling kit to accompany our lead-sampling kit.
- Evaluate the predictive validity of home sampling kits for lead-contaminated floor dust to identify children who have blood lead levels of 10 mg/dl or higher by community participants compared with repeat samples taken by trained, community workers.
- Evaluate the reliability of home sampling kits for pesticides in dust collected by community participants compared with trained, community workers.
- Disseminate data on the reliability of home sampling tests and provide tools for families to collect environmental samples for large, population-based studies.
- Develop a Healthy Homes Resource Center at the Better Housing League to disseminate information to the community about residential hazards.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Home test kit | – | – |
Who may qualify
- Ages
- 3 months to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children <5 years receiving care via Babies Milk Fund Clinics
Key inclusion criteria (1 listed)
- Venous blood lead In residence 3 months Child less than 5 years of age Sampler greater than 18 years of age
Key exclusion criteria (1 listed)
- Cannot read or understand English Physically unable to conduct field sampling Outside of theGreater Cincinnati area
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 and Pesticide Levels
Time frame: One time home visit 3-5 days after distribution of kits
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.
Sandy M Roda, BS principal investigator
University of 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 Poisoning, Lead, 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 1 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 and Pesticide Levels (time frame: One time home visit 3-5 days after distribution of kits). 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.