NCT00342849

Brief Summary

The Treatment of Lead-Exposed Children (TLC) clinical trial compared the effect of lead chelation with succimer to placebo therapy. TLC was a randomized, double-blind, placebo-controlled clinical trial with sites in Cincinnati and Columbus, Ohio, Philadelphia, Pennsylvania, Baltimore, Maryland and Newark, New Jersey. The study was designed to test outcomes in IQ, neuropsychological function, behavior, physical growth and blood pressure three years after initiation of treatment. Enrollment was conducted between 1994 and 1997, with completion of the initial three-year follow-up in 2000.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
780

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jul 1994

Longer than P75 for phase_3

Geographic Reach
1 country

4 active sites

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

July 15, 1994

Completed
11.9 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2007

Completed
7.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2015

Completed
Last Updated

April 5, 2018

Status Verified

June 10, 2015

Enrollment Period

13.1 years

First QC Date

June 19, 2006

Last Update Submit

April 4, 2018

Conditions

Lead Exposure

Keywords

Clinical TrialLow-level Lead PoisoningChelationDevelopmental AssessmentSuccimer

Outcome Measures

Primary Outcomes (1)

  • Efficacy

    Annually

Study Arms (2)

1

EXPERIMENTAL

Scuccimer Treatment Group

Drug: Succimer

2

PLACEBO COMPARATOR

In order to provide placebo with an odor comparable to that of succimer, the Drug Distribution Center will place a small canister containing 200 mg of active drug into each bottle of placebo drug. A canister containing 200 mg of placebo will be placed inside each bottle of succimer so that all bottles will appear the same.

Drug: Placebo

Interventions

SuccimerDRUG

Succimer (2,3-meso-dimercaptosuccinic acid) is an orally active dithiol compound that is a relatively specific chelating agent for heavy metals, especially lead, arsenic and mercury. The drug undergoes limited absorption in the gastrointestinal tract and then is rapidly metabolized to mixed disulfides which are eliminated in the urine. Blood levels decline slowly with an apparent elimination half-life of about 48 hours in adults.

1
PlaceboDRUG
2

Eligibility Criteria

Age12 Months - 33 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • The study population will reflect the population known to be at greatest risk to lead exposure, i.e., low income, urban, African-American children.

You may not qualify if:

  • Linguistic minorities will be excluded in all centers except Newark, where Hispanic children make up a sizable portion of the population and will be included.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Kennedy Krieger Institute

Baltimore, Maryland, 21205, United States

Location

University of Medicine and Dentistry of New Jersey

Newark, New Jersey, 07103, United States

Location

Childrens Hospital, Columbus

Columbus, Ohio, 43205-2696, United States

Location

Childrens Hospital, Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (5)

  • Littman E, Goldstein MH, Kasen L, Levitt MF, Wedeen RP. The relationship of the intrarenal distribution of Hg203-chlormerodrin to the diuretic effect. J Pharmacol Exp Ther. 1966 Apr;152(1):130-8. No abstract available.

    PMID: 5937397BACKGROUND

  • Levitt MF, Goldstein MH, Lenz PR, Wedeen R. Mercurial diuretics. Ann N Y Acad Sci. 1966 Nov 22;139(2):375-87. doi: 10.1111/j.1749-6632.1966.tb41211.x. No abstract available.

    PMID: 5230281BACKGROUND

  • Wedeen RP, Jernow HI. Autoradiographic study of cellular transport of hippuran-125I in the rat nephron. Am J Physiol. 1968 Apr;214(4):776-85. doi: 10.1152/ajplegacy.1968.214.4.776. No abstract available.

    PMID: 5642938BACKGROUND

  • Cao Y, Chen A, Bottai M, Caldwell KL, Rogan WJ. The impact of succimer chelation on blood cadmium in children with background exposures: a randomized trial. J Pediatr. 2013 Aug;163(2):598-600. doi: 10.1016/j.jpeds.2013.03.009. Epub 2013 Apr 16.

    PMID: 23601497DERIVED

  • Cao Y, Chen A, Jones RL, Radcliffe J, Dietrich KN, Caldwell KL, Peddada S, Rogan WJ. Efficacy of succimer chelation of mercury at background exposures in toddlers: a randomized trial. J Pediatr. 2011 Mar;158(3):480-485.e1. doi: 10.1016/j.jpeds.2010.08.036.

    PMID: 20889164DERIVED

MeSH Terms

Interventions

Succimer

Intervention Hierarchy (Ancestors)

SuccinatesDicarboxylic AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsSulfhydryl CompoundsSulfur Compounds

Study Officials

  • Walter Rogan, M.D.

    National Institute of Environmental Health Sciences (NIEHS)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

June 19, 2006

First Posted

June 21, 2006

Study Start

July 15, 1994

Primary Completion

August 29, 2007

Study Completion

June 10, 2015

Last Updated

April 5, 2018

Record last verified: 2015-06-10

Locations

US(4)