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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
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lead Poisoning focused on measuring environmental/toxic disorders, lead poisoning, rare disease

Eligibility Criteria

0 Years - 6 Years (Child)All SexesDoes not accept healthy volunteers

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

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

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