Randomized Study of Succimer (Dimercaptosuccinic Acid) on Growth of Lead-Poisoned Children
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|ClinicalTrials.gov Identifier: NCT00004838|
Recruitment Status : Completed
First Posted : February 25, 2000
Last Update Posted : June 24, 2005
Compare growth of lead-poisoned children receiving succimer (dimercaptosuccinic acid; DMSA) plus standard treatment to those receiving standard treatment only.
|Condition or disease||Intervention/treatment||Phase|
|Lead Poisoning||Drug: succimer||Not Applicable|
PROTOCOL OUTLINE: This is randomized study. Patients are randomized to receive succimer in addition to standard treatment (arm I) or standard treatment only (arm II).
Succimer is administered orally 3 times a day for 7 days, then twice daily for 19 days. Patients may receive up to 3 courses.
Standard treatment consists of a medical history and physical examination, environmental assessment with modification to reduce lead exposure, dietary modifications to decrease lead absorption, the use of a daily multivitamin and mineral supplement with iron, developmental screening and intervention, and frequent follow up of lead levels.
If blood lead level rises above 45 mcg/dL, patient receives succimer regardless of treatment arm originally assigned.
Patients are followed every 3-4 weeks for 2 months, then every 3 months for 6 months, and then every 6 months thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||175 participants|
|Study Start Date :||September 1997|
|Study Completion Date :||July 1998|
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 ClinicalTrials.gov identifier (NCT number): NCT00004838
|Study Chair:||Marcel J. Casavant||Nationwide Children's Hospital|