NCT00004838

Randomized Study of Succimer (Dimercaptosuccinic Acid) on Growth of Lead-Poisoned Children

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 175 (planned)
• Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · NIH
• Sex: All
• Age: 0 Years – 6 Years
• Healthy volunteers: Not accepted

Summary

OBJECTIVES: Compare growth of lead-poisoned children receiving succimer (dimercaptosuccinic acid; DMSA) plus standard treatment to those receiving standard treatment only.

Detailed description

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.

Conditions

• Lead Poisoning

Interventions

Type	Name	Description
DRUG	succimer

Timeline

• Start date: 1997-09-01
• Completion: 1998-07-01
• First posted: 2000-02-25
• Last updated: 2005-06-24