NCT00004838

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
175

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 1997

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1997

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 1998

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 25, 2000

Completed
Last Updated

June 24, 2005

Status Verified

September 1, 1998

First QC Date

February 24, 2000

Last Update Submit

June 23, 2005

Conditions

Lead Poisoning

Keywords

environmental/toxic disorderslead poisoningrare disease

Interventions

succimerDRUG

Eligibility Criteria

Age0 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 9690266BACKGROUND

MeSH Terms

Conditions

Lead PoisoningRare Diseases

Interventions

Succimer

Condition Hierarchy (Ancestors)

Heavy Metal PoisoningPoisoningChemically-Induced DisordersDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SuccinatesDicarboxylic AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsSulfhydryl CompoundsSulfur Compounds

Study Officials

  • Marcel J. Casavant

    Nationwide Children's Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

February 24, 2000

First Posted

February 25, 2000

Study Start

September 1, 1997

Study Completion

July 1, 1998

Last Updated

June 24, 2005

Record last verified: 1998-09