Randomized Study of Succimer (Dimercaptosuccinic Acid) on Growth of Lead-Poisoned Children
Primary Purpose
Lead Poisoning
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
succimer
Sponsored by
About this trial
This is an interventional treatment trial for Lead Poisoning focused on measuring environmental/toxic disorders, lead poisoning, rare disease
Eligibility 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)
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00004838
First Posted
February 24, 2000
Last Updated
June 23, 2005
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators
Nationwide Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00004838
Brief Title
Randomized Study of Succimer (Dimercaptosuccinic Acid) on Growth of Lead-Poisoned Children
Study Type
Interventional
2. Study Status
Record Verification Date
September 1998
Overall Recruitment Status
Completed
Study Start Date
September 1997 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 1998 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators
Nationwide Children's Hospital
4. Oversight
5. Study Description
Brief Summary
OBJECTIVES:
Compare growth of lead-poisoned children receiving succimer (dimercaptosuccinic acid; DMSA) plus standard treatment to those receiving standard treatment only.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lead Poisoning
Keywords
environmental/toxic disorders, lead poisoning, rare disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Allocation
Randomized
Enrollment
175 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
succimer
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcel J. Casavant
Organizational Affiliation
Nationwide Children's Hospital
Official's Role
Study Chair
12. IPD Sharing Statement
Citations:
PubMed Identifier
9690266
Citation
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. doi: 10.1046/j.1365-3016.1998.00122.x.
Results Reference
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Randomized Study of Succimer (Dimercaptosuccinic Acid) on Growth of Lead-Poisoned Children
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