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

This study has been completed.

First Received: February 24, 2000 Last Updated: June 23, 2005 History of Changes

Sponsor:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator:	Nationwide Children's Hospital
Information provided by:	Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:	NCT00004838

Purpose

OBJECTIVES:

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

Condition	Intervention
Lead Poisoning	Drug: succimer

Study Type:	Interventional
Study Design:	Treatment, Randomized

Resource links provided by NLM:

MedlinePlus related topics: Lead Poisoning Poisoning

Drug Information available for: Succimer

U.S. FDA Resources

Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment:	175
Study Start Date:	September 1997
Estimated Study Completion Date:	July 1998

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.

Eligibility

Ages Eligible for Study:	up to 6 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004838

Sponsors and Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Nationwide Children's Hospital

Investigators

Study Chair:

Marcel J. Casavant

Nationwide Children's Hospital

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
Study First Received:	February 24, 2000
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004838 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):

environmental/toxic disorders
lead poisoning
rare disease

Additional relevant MeSH terms:

Succimer
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Poisoning
Lead Poisoning

Disorders of Environmental Origin
Chelating Agents
Protective Agents
Pharmacologic Actions
Antidotes

ClinicalTrials.gov processed this record on November 09, 2009