Randomized Study of Succimer (Dimercaptosuccinic Acid) on Growth of Lead-Poisoned Children
Compare growth of lead-poisoned children receiving succimer (dimercaptosuccinic acid; DMSA) plus standard treatment to those receiving standard treatment only.
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Study Start Date:||September 1997|
|Estimated Study Completion Date:||July 1998|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004838
|Study Chair:||Marcel J. Casavant||Nationwide Children's Hospital|