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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00926406
Recruitment Status : Unknown
Verified April 2010 by Chang Gung Memorial Hospital.
Recruitment status was:  Recruiting
First Posted : June 23, 2009
Last Update Posted : April 7, 2010
Information provided by:
Chang Gung Memorial Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Anemia Malnutrition Inflammation Lead Poisoning Drug: lead chelation therapy Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : April 2010
Estimated Primary Completion Date : October 2011
Estimated Study Completion Date : December 2011

Intervention Details:
  • 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.

Primary Outcome Measures :
  1. The primary end point is morbidity or mortality during the follow-up period. [ Time Frame: 18 months follow-up period ]

Secondary Outcome Measures :
  1. A secondary end point is the change in HB, albumin, Cr and Hs CRP during the follow up period. [ Time Frame: 18 months follow-up period ]

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • MHD patients have dialyzed for more than 6 months and age >18 and < 90 year-old

Exclusion Criteria:

  • Patients with malignancies and obvious infectious diseases as well as those who are hospitalized or underwent surgery or renal transplantation within the 3 months preceding the investigation;Patients with a history of occupational exposure to heavy metals, metal intoxication, living in metal-contaminated areas were also excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00926406

Contact: Ja-Liang Lin, MD 886-3-3281300 ext 8892

Chang Gung Memorial Hospital Recruiting
Taoyuan, Taiwan, 33333
Contact: Tsang-Tang Hsieh, MD   
Principal Investigator: Ja-Liang Lin, MD         
Sponsors and Collaborators
Chang Gung Memorial Hospital

Responsible Party: Institutional Review Board, Chang Gung Memorial Hospital Identifier: NCT00926406     History of Changes
Other Study ID Numbers: 96-1455C
First Posted: June 23, 2009    Key Record Dates
Last Update Posted: April 7, 2010
Last Verified: April 2010

Keywords provided by Chang Gung Memorial Hospital:
Environmental lead exposure, maintenance hemodialysis; blood lead levels, EDTA chelating agents, malnutrition, anemia, inflammation, mortality.
To determine whether lead chelation therapy improves the anemia, malnutrition, inflammation, morbidity or mortality in hemodialysis patients.

Additional relevant MeSH terms:
Lead Poisoning
Pathologic Processes
Hematologic Diseases
Nutrition Disorders
Chemically-Induced Disorders