Treatment of Lead-Exposed Children Trial

Completed · Phase 3 · Has a placebo group

Conditions studied: Lead Exposure

In brief

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.

Key facts

Study ID

NCT00342849

Run by

National Institute of Environmental Health Sciences (NIEHS)

People needed

780

Starts

1994-07-15

Expected to finish

2015-06-10

Last updated by the study team

2018-04-05

Who can join

Age: 1 and older, up to 3. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Kennedy Krieger Institute — Baltimore, Maryland, United States
• University of Medicine and Dentistry of New Jersey — Newark, New Jersey, United States
• Childrens Hospital, Columbus — Columbus, Ohio, United States
• Childrens Hospital, Philadelphia — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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