NCT00013819

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
944

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 1997

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 1997

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2001

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2001

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 30, 2001

Completed
Last Updated

April 14, 2015

Status Verified

April 1, 2015

Enrollment Period

4 years

First QC Date

March 29, 2001

Last Update Submit

April 13, 2015

Conditions

Lead Poisoning

Keywords

lead poisoningcentral nervous systemperipheral nervous systemoccupational healthgenetic susceptibility

Eligibility Criteria

Age17 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Lead workers in South Korea in one of 26 specific lead-using facilities. Population controls in South Korea.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Lead PoisoningGenetic Predisposition to Disease

Condition Hierarchy (Ancestors)

Heavy Metal PoisoningPoisoningChemically-Induced DisordersDisease SusceptibilityDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

March 29, 2001

First Posted

March 30, 2001

Study Start

February 1, 1997

Primary Completion

February 1, 2001

Study Completion

February 1, 2001

Last Updated

April 14, 2015

Record last verified: 2015-04