AsthmaNCT00339573
National Survey of Lead and Allergen Hazards in Housing
An observational study of Asthma and Allergy, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
Trial summary
We propose to conduct a scientifically valid, descriptive survey to measure the prevalence and levels of lead in dust, soil, and paint, and the prevalence and levels of various indoor allergens in floor and bedding dust in the nation's housing stock. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- How many people
- 831 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 1998to 31 Aug 1999
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A nationally representative sample of 831 housing units, inhabited by 2,456 individuals, within 75 different locations throughout the US was surveyed.
Who may be able to join
- The target population for the Survey is the national housing stock of approximately 95 million housing units.
- The decision to include or exclude a subset is usually based on such factors as relevancy to the study objectives, availability of data from other sources, and effort required to obtain the study data.
- None of the possible housing type exclusion or oversampling proposals are based upon gender, race, ethnic, cultural, or biological factors.
- Housing built after 1977.
- Housing units in multi-family buildings.
- Manufactured housing units, i.e., mobile homes and trailers.
Who cannot join
- Housing where children are not permitted to live (elderly housing, nursing homes, college dormitories, etc.).
- Group housing - both institutional (prisons or jails, detention centers, hospitals, military housing, etc.) and non-institutional (dormitories, fraternities, orphanages, rooming houses, missions, work camps, convents, etc.).
- Vacant housing.
- Short-term housing. This category includes homes which are not the resident's sole or permanent home, and which the resident present at the time of field data collection spends less than three months per year. This includes seasonal, occasional use, recreational, and second homes, as well as homes for migrant workers.
- Hotels and motels.
Trial locations and contacts
1 site in 1 country.
United States1 site
NIEHS, Research Triangle Park
Research Triangle Park, North Carolina, 27709
About this study
Official title: National Survey of Lead Hazards and Allergens in Housing
We propose to conduct a scientifically valid, descriptive survey to measure the prevalence and levels of lead in dust, soil, and paint, and the prevalence and levels of various indoor allergens in floor and bedding dust in the nation's housing stock. The survey strategy is a population-based, multi-stage area probability sample designed to represent all 50 states. The survey will include approximately 1000 homes in at least 100 primary sampling units (PSU, a metropolitan area or cluster of counties). Residents of candidate participant housing units (HUs) will initially be contacted by a letter to introduce and provide a brief explanation of the study. A field interviewer will then visit each candidate HU to screen and recruit eligible units into the study. A short Screening Questionnaire will be administered to an adult HU resident and an invitation will be extended to those HUs that are eligible to participate in the study. A field data collection visit will be scheduled for the following week, at the resident's convenience. The collection visit will be conducted by two member team (including the same field interviewer that will conduct the screening/recruiting visit) and will consist of administration of an informed consent form and Data Collection Questionnaire, completion of home observation forms, collection of interior dust and exterior soil samples, and conduct of nondestructive paint lead analysis on both interior and exterior walls. Soil and dust samples will be shipped to analytical laboratories for lead and allergen analysis. Extensive survey design, procedure, and reporting details are provided in the National Survey Lead Hazards and Allergens in Housing: Protocol and Sample Design Report (Attachment A). It is anticipated that this study will provide allergen-specific data regarding: 1) housing conditions, demographic factors, and climate to facilitate evaluation of regional, ethnic, socioeconomic, and housing characteristic differences in the indoor allergen burden; 2) an estimate of indoor allergen exposure in the U.S. population; 3) baseline data that can be used to stimulate future studies which attempt to correlate allergen exposure to disease outcome. The study will yield lead hazard data to: 1) estimate the number and percent of homes with dust and soil lead levels above selected thresholds; 2) identify sources of lead in dust in housing; 3) permit future analysis of lead hazard control strategies an costs, including associated policy and regulatory guidelines.
Read the detailed description
We propose to conduct a scientifically valid, descriptive survey to measure the prevalence and levels of lead in dust, soil, and paint, and the prevalence and levels of various indoor allergens in floor and bedding dust in the nation's housing stock. The survey strategy is a population-based, multi-stage area probability sample designed to represent all 50 states. The survey will include approximately 1000 homes in at least 100 primary sampling units (PSU, a metropolitan area or cluster of counties). Residents of candidate participant housing units (HUs) will initially be contacted by a letter to introduce and provide a brief explanation of the study. A field interviewer will then visit each candidate HU to screen and recruit eligible units into the study. A short Screening Questionnaire will be administered to an adult HU resident and an invitation will be extended to those HUs that are eligible to participate in the study. A field data collection visit will be scheduled for the following week, at the resident's convenience. The collection visit will be conducted by a two member team (including the same field interviewer that will conduct the screening/recruiting visit) and will consist of administration of an informed consent form and Data Collection Questionnaire, completion of home observation forms, collection of interior dust and exterior soil samples, and conduct of nondestructive paint lead analyses on both interior and exterior walls. Soil and dust samples will be shipped to analytical laboratories for lead and allergen analysis. Extensive survey design, procedure, and reporting details are provided in the National Survey Lead Hazards and Allergens in Housing: Protocol and Sample Design Report. It is anticipated that this study will provide allergen-specific data regarding: 1) housing conditions, demographic factors, and climate to facilitate evaluation of regional, ethnic, socioeconomic, and housing characteristic differences in the indoor allergen burden; 2) an estimate of indoor allergen exposure in the U.S. population; 3) baseline data that can be used as a reference point for future allergen surveys; and 4) a database that can be used to stimulate future studies which attempt to correlate allergen exposure to disease outcome. The study will yield lead hazard data to: 1) estimate the number and percent of homes with dust and soil lead levels above selected thresholds; 2) identify sources of lead in dust in housing; 3) permit future analysis of lead hazard control strategies and costs, including associated policy and regulatory guidelines.
- Keywords
- Asthma, Exposure, Home, Indoor, Allergy
- Medical subject headings
- Asthma, Hypersensitivity
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 |
|---|---|---|
| National Housing Stock | The target population of this study was the national housing stock (1998-1999) ofapproximately 95 million housing units. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentrations of indoor allergens and lead
The primary outcomes included concentrations of common indoor allergens (dust mite, cat, dog, cockroach, mouse, and Alternaria) in household dust and lead levels in paint, household dust, and soil in the nation's housing.
Measured: Cross-sectional assessment during the field visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start30 Jun 1998
- Primary completion31 Aug 1999
- Study completion31 Aug 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 831 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Darryl C Zeldin, M.D., Principal investigator, National Institute of Environmental Health Sciences (NIEHS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00339573
- Sponsor's protocol ID
- 999998033
- Other IDs
- OH98-E-N033
- Status last verified
- Oct 2020
- First submitted
- 19 Jun 2006
- Last updated
- 8 Oct 2020
- Results posted
- No
Publications
Needleman HL, Gatsonis CA. Low-level lead exposure and the IQ of children. A meta-analysis of modern studies. JAMA. 1990 Feb 2;263(5):673-8.
PubMed 2136923Pocock SJ, Smith M, Baghurst P. Environmental lead and children's intelligence: a systematic review of the epidemiological evidence. BMJ. 1994 Nov 5;309(6963):1189-97. doi: 10.1136/bmj.309.6963.1189.
PubMed 7987149Pollart SM, Mullins DE, Vailes LD, Hayden ML, Platts-Mills TA, Sutherland WM, Chapman MD. Identification, quantitation, and purification of cockroach allergens using monoclonal antibodies. J Allergy Clin Immunol. 1991 Feb;87(2):511-21. doi: 10.1016/0091-6749(91)90010-l.
PubMed 1993811
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Survey of Lead Hazards and Allergens in Housing
- ClinicalTrials.gov ID
- NCT00339573
- Acronym / sponsor ID
- 999998033
- Keywords
- Asthma, Exposure, Home, Indoor, Allergy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 831 participants (actual)
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)US National Institutes of Health
- Study start
- 30 Jun 1998 (actual)
- Primary completion
- 31 Aug 1999 (actual)
- Study completion
- 31 Aug 1999 (actual)
- First posted
- 21 Jun 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.
We propose to conduct a scientifically valid, descriptive survey to measure the prevalence and levels of lead in dust, soil, and paint, and the prevalence and levels of various indoor allergens in floor and bedding dust in the nation's housing stock. The survey strategy is a population-based, multi-stage area probability sample designed to represent all 50 states. The survey will include approximately 1000 homes in at least 100 primary sampling units (PSU, a metropolitan area or cluster of counties). Residents of candidate participant housing units (HUs) will initially be contacted by a letter to introduce and provide a brief explanation of the study. A field interviewer will then visit each candidate HU to screen and recruit eligible units into the study. A short Screening Questionnaire will be administered to an adult HU resident and an invitation will be extended to those HUs that are eligible to participate in the study. A field data collection visit will be scheduled for the following week, at the resident's convenience. The collection visit will be conducted by two member team (including the same field interviewer that will conduct the screening/recruiting visit) and will consist of administration of an informed consent form and Data Collection Questionnaire, completion of home observation forms, collection of interior dust and exterior soil samples, and conduct of nondestructive paint lead analysis on both interior and exterior walls. Soil and dust samples will be shipped to analytical laboratories for lead and allergen analysis. Extensive survey design, procedure, and reporting details are provided in the National Survey Lead Hazards and Allergens in Housing: Protocol and Sample Design Report (Attachment A). It is anticipated that this study will provide allergen-specific data regarding: 1) housing conditions, demographic factors, and climate to facilitate evaluation of regional, ethnic, socioeconomic, and housing characteristic differences in the indoor allergen burden; 2) an estimate of indoor allergen exposure in the U.S. population; 3) baseline data that can be used to stimulate future studies which attempt to correlate allergen exposure to disease outcome. The study will yield lead hazard data to: 1) estimate the number and percent of homes with dust and soil lead levels above selected thresholds; 2) identify sources of lead in dust in housing; 3) permit future analysis of lead hazard control strategies an costs, including associated policy and regulatory guidelines.
Detailed description
We propose to conduct a scientifically valid, descriptive survey to measure the prevalence and levels of lead in dust, soil, and paint, and the prevalence and levels of various indoor allergens in floor and bedding dust in the nation's housing stock. The survey strategy is a population-based, multi-stage area probability sample designed to represent all 50 states. The survey will include approximately 1000 homes in at least 100 primary sampling units (PSU, a metropolitan area or cluster of counties). Residents of candidate participant housing units (HUs) will initially be contacted by a letter to introduce and provide a brief explanation of the study. A field interviewer will then visit each candidate HU to screen and recruit eligible units into the study. A short Screening Questionnaire will be administered to an adult HU resident and an invitation will be extended to those HUs that are eligible to participate in the study. A field data collection visit will be scheduled for the following week, at the resident's convenience. The collection visit will be conducted by a two member team (including the same field interviewer that will conduct the screening/recruiting visit) and will consist of administration of an informed consent form and Data Collection Questionnaire, completion of home observation forms, collection of interior dust and exterior soil samples, and conduct of nondestructive paint lead analyses on both interior and exterior walls. Soil and dust samples will be shipped to analytical laboratories for lead and allergen analysis. Extensive survey design, procedure, and reporting details are provided in the National Survey Lead Hazards and Allergens in Housing: Protocol and Sample Design Report. It is anticipated that this study will provide allergen-specific data regarding: 1) housing conditions, demographic factors, and climate to facilitate evaluation of regional, ethnic, socioeconomic, and housing characteristic differences in the indoor allergen burden; 2) an estimate of indoor allergen exposure in the U.S. population; 3) baseline data that can be used as a reference point for future allergen surveys; and 4) a database that can be used to stimulate future studies which attempt to correlate allergen exposure to disease outcome. The study will yield lead hazard data to: 1) estimate the number and percent of homes with dust and soil lead levels above selected thresholds; 2) identify sources of lead in dust in housing; 3) permit future analysis of lead hazard control strategies and costs, including associated policy and regulatory guidelines.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| National Housing Stock | – | –The target population of this study was the national housing stock (1998-1999) ofapproximately 95 million housing units. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A nationally representative sample of 831 housing units, inhabited by 2,456 individuals, within 75 different locations throughout the US was surveyed.
Key inclusion criteria (6 listed)
- The target population for the Survey is the national housing stock of approximately 95 million housing units.
- The decision to include or exclude a subset is usually based on such factors as relevancy to the study objectives, availability of data from other sources, and effort required to obtain the study data.
- None of the possible housing type exclusion or oversampling proposals are based upon gender, race, ethnic, cultural, or biological factors.
- Housing built after 1977.
- Housing units in multi-family buildings.
Key exclusion criteria (5 listed)
- Housing where children are not permitted to live (elderly housing, nursing homes, college dormitories, etc.).
- Group housing - both institutional (prisons or jails, detention centers, hospitals, military housing, etc.) and non-institutional (dormitories, fraternities, orphanages, rooming houses, missions, work camps, convents, etc.).
- Vacant housing.
- Short-term housing. This category includes homes which are not the resident's sole or permanent home, and which the resident present at the time of field data collection spends less than three months per year. This includes seasonal, occasional use, recreational, and second homes, as well as homes for migrant workers.
- Hotels and motels.
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
Concentrations of indoor allergens and lead
Time frame: Cross-sectional assessment during the field visit
The primary outcomes included concentrations of common indoor allergens (dust mite, cat, dog, cockroach, mouse, and Alternaria) in household dust and lead levels in paint, household dust, and soil in the nation's housing.
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 8 Oct 2020.
- Background: PubMed 2136923Needleman HL, Gatsonis CA. Low-level lead exposure and the IQ of children. A meta-analysis of modern studies. JAMA. 1990 Feb 2;263(5):673-8.
- Background: PubMed 7987149Pocock SJ, Smith M, Baghurst P. Environmental lead and children's intelligence: a systematic review of the epidemiological evidence. BMJ. 1994 Nov 5;309(6963):1189-97. doi: 10.1136/bmj.309.6963.1189.
- Background: PubMed 1993811Pollart SM, Mullins DE, Vailes LD, Hayden ML, Platts-Mills TA, Sutherland WM, Chapman MD. Identification, quantitation, and purification of cockroach allergens using monoclonal antibodies. J Allergy Clin Immunol. 1991 Feb;87(2):511-21. doi: 10.1016/0091-6749(91)90010-l.
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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.
Darryl C Zeldin, M.D. principal investigator
National Institute of Environmental Health Sciences (NIEHS)
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 Asthma and Allergy, 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 6 inclusion and 5 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 8 Oct 2020. 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?
Concentrations of indoor allergens and lead (time frame: Cross-sectional assessment during the field visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00339573, which also lists 3 linked publications.
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 8 Oct 2020.