ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Randomized Study of Succimer (Dimercaptosuccinic Acid) on Growth of Lead-Poisoned Children

This study has been completed.

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

MedlinePlus related topics:   Lead Poisoning    Poisoning   

Drug Information available for:   Succimer   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized

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

Investigators
Study Chair:     Marcel J. Casavant     Nationwide Children's Hospital    
  More Information


Publications:

Study ID Numbers:   199/13576, CHRF-96-HS-066, CH-OHIO-5F32ES05651
First Received:   February 24, 2000
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00004838
Health Authority:   United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):
environmental/toxic disorders  
lead poisoning  
rare disease  

Study placed in the following topic categories:
Succimer
Rare Diseases
Lead Poisoning
Poisoning
Disorders of Environmental Origin

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Chelating Agents
Protective Agents
Pharmacologic Actions
Antidotes

ClinicalTrials.gov processed this record on December 03, 2008




Links to all studies - primarily for crawlers