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Environmental Exposure to Lead and Its Health Effects on Patients With Maintenance Hemodialysis

NCT00926406 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2010-04-07

No results posted yet for this study

Summary

One thousand patients with LHD who have no history of exposure to lead will be observed for 18 months. Blood lead level(BLL), biochemical data, hemoglobin, albumin, Cr, high sensitivity C-reactive protein (HsCRP), and blood cell counts are assessed at baseline. The morbidity and mortality are recorded in detail. Then, one hundred subjects with high BLL (\>20μg/dl) will be randomly assigned to the study and control groups. For 3-6 months, the 50 patients in the study group will receive lead-chelation therapy with calcium disodium EDTA weekly until the BLB falls below BLL\< 5 μg/dl, and the 50 control group patients receive weekly placebo for 12 weeks. During the ensuing 18 months, the BLL, biochemical data will be regularly followed up every 3 months. BLL is measured every 6 months. If BLL of the study group patients increase \>10 μg/dl, the chelation therapy will be performed again until their BLL is \<5 μg/dl. The primary end point is morbidity or mortality during the observation and follow-up period. A secondary end point is the change in hemoglobin, albumin, Cr and Hs CRP during the follow up period.

Conditions

Interventions

DRUG

lead chelation therapy

Patients with lead poisoning (BLL\> 20μg/dl) are randomly assigned to a control or chelation group, on the 1:1 proportion. During the 3 months, 50 chelation group patients receive 2-hour weekly intravenous infusions of one vial (1 g) of calcium di-sodium EDTA mixed with 200 ml of normal saline until BLB is BLL \< 5 μg/dl. Fifty control patients receive weekly 2-hour infusions of one vial (20 ml) of 50% glucose mixed with 200 ml of normal saline over a period of 12 weeks9.

Sponsors & Collaborators

  • Chang Gung Memorial Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2011-10-31
Completion
2011-12-31

Countries

  • Taiwan

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00926406 on ClinicalTrials.gov