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

Lead Poisoning Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004838
• Other study ID #: 199/13576
• Secondary ID: CHRF-96-HS-066CH
• Status: Completed
• Phase: N/A
• First received: February 24, 2000
• Last updated: June 23, 2005
• Start date: September 1997
• Est. completion date: July 1998

Study information

• Verified date: September 1998
• Source: Office of Rare Diseases (ORD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

OBJECTIVES:

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: July 1998
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 6 Years

Eligibility

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Asymptomatic children with confirmed venous blood lead of at least 20 mcg/dL and less than 45 mcg/dL Children with blood lead of 45 mcg/dL or greater are not randomized in this study since they probably will receive succimer regardless of being enrolled in this study --Patient Characteristics-- Other: No contraindications to the use of succimer (i.e., allergy or a lack of lead safe environment in which to live during chelation)

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lead Poisoning
• Poisoning

Intervention

Drug:
• succimer

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Nationwide Children's Hospital

References & Publications (1)

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. — View Citation