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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lead chelation therapy | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The primary end point is morbidity or mortality during the follow-up period. | 18 months follow-up period |
| Measure | Description | Time Frame |
|---|---|---|
| A secondary end point is the change in HB, albumin, Cr and Hs CRP during the follow up period. | 18 months follow-up period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ja-Liang Lin, MD | Contact | 886-3-3281300 | 8892 | jllin@adm.cgmh.org.tw |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang Gung Memorial Hospital | Recruiting | Taoyuan | Taiwan | 33333 | Taiwan |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| D044342 | Malnutrition |
| D007249 | Inflammation |
| D007855 | Lead Poisoning |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000075322 | Heavy Metal Poisoning |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |