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

This study has been completed.
Sponsor:
Collaborator:
Nationwide Children's Hospital
Information provided by:
Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:
NCT00004838
First received: February 24, 2000
Last updated: June 23, 2005
Last verified: September 1998
History of Changes
  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: Allocation: Randomized
Primary Purpose: Treatment

Resource links provided by NLM:

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:

ClinicalTrials.gov Identifier: NCT00004838     History of Changes
Other Study ID Numbers: 199/13576, CHRF-96-HS-066, CH-OHIO-5F32ES05651
Study First Received: February 24, 2000
Last Updated: June 23, 2005
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:
Lead Poisoning
Poisoning
Substance-Related Disorders
Succimer
Chelating Agents
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antidotes
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 17, 2013