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| Tracking Information | |
|---|---|
| First Received Date ICMJE | March 29, 2001 |
| Last Updated Date | June 23, 2005 |
| Start Date ICMJE | February 1997 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00013819 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | Exposure, Dose, Body Burden and Health Effects of Lead |
| Official Title ICMJE | |
| Brief Summary | This is a study of the effects that lead has on the health of the central nervous system (for example, memory), peripheral nervous system (for example, sensation and strength in the hands and fingers), kidneys, blood pressure, and the blood forming system. A total of 803 lead workers and 135 persons without occupational lead exposure are being studied in South Korea. Lead in the body is being assessed by measurement of blood lead, chelatable lead (an estimate of lead in the tissues), and lead in bone. Subjects are tested three times each over three years. Several genetic factors are also being assessed for the role they play in the health effects of lead. These genes are known to differ among individuals. We are interested to know whether different forms of the same genes can modify the effect lead has on health. |
| Detailed Description | |
| Study Phase | |
| Study Type ICMJE | Observational |
| Study Design ICMJE | Natural History, Longitudinal, Defined Population, Prospective Study |
| Condition ICMJE | Lead Poisoning |
| Intervention ICMJE | |
| Study Arms / Comparison Groups | |
| Publications * | |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Active, not recruiting |
| Enrollment ICMJE | 944 |
| Completion Date | February 2002 |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | Lead workers in South Korea in one of 26 specific lead-using facilities. Population controls in South Korea. |
| Gender | Both |
| Ages | 17 Years to 70 Years |
| Accepts Healthy Volunteers | Yes |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | |
| Administrative Information | |
| NCT ID ICMJE | NCT00013819 |
| Responsible Party | |
| Study ID Numbers ICMJE | 7198-CP-001 |
| Study Sponsor ICMJE | National Institute of Environmental Health Sciences (NIEHS) |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | National Institute of Environmental Health Sciences (NIEHS) |
| Verification Date | July 2002 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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