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

This study has been completed.

Sponsors and Collaborators: National Institute of Child Health and Human Development (NICHD)
Children's Hospital Columbus
Information provided by: Office of Rare Diseases (ORD)

Purpose

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

Further Study Details: 

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.

Eligibility

Ages Eligible for Study:  up to  6 Years,  Genders Eligible for Study:  Both

Criteria

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)

Location Information

Study chairs or principal investigators

Marcel J. Casavant,  Study Chair,  Children's Hospital Columbus   

More Information

Publications

[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.

Study ID Numbers:  199/13576; CHRF-96-HS-066; CH-OHIO-5F32ES05651
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


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

Resources

  • Lead (Centers for Disease Control and Prevention)
  • Lead (Lab Tests Online)