Randomized Study of Succimer (Dimercaptosuccinic Acid) on Growth of Lead-Poisoned Children - Article
Clinical Trial: Randomized Study of Succimer (Dimercaptosuccinic Acid) on Growth of Lead-Poisoned Children
This study has been completed.
OBJECTIVES: Compare growth of lead-poisoned children receiving succimer (dimercaptosuccinic acid; DMSA) plus standard treatment to those receiving standard treatment only.
|Condition||Treatment or Intervention|
|Lead Poisoning || Drug: succimer |
MedlinePlus related topics: Lead Poisoning
Study Type: Interventional
Study Design: Treatment, Randomized
Expected Total Enrollment: 175
Study start: September 1997; Study completion: 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.
Ages Eligible for Study: up to 6 Years, Genders Eligible for Study: Both
Marcel J. Casavant, Study Chair, Children's Hospital Columbus
[No authors listed] The Treatment of Lead-exposed Children (TLC) trial: design and recruitment for a study of the effect of oral chelation on growth and development in toddlers. Paediatr Perinat Epidemiol. 1998 Jul;12(3):313-33.
Record last reviewed: September 1998
Last Updated: October 13, 2004
Record first received: February 24, 2000
ClinicalTrials.gov Identifier: NCT00004838
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Cache Date: April 9, 2005