CompletedPhase 3

Treatment of Lead-Exposed Children Trial

United States780 participantsStarted 1994-07-15

Plain-language 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.

Who can participate

Age range12 Months – 33 Months

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Efficacy

Timeframe: Annually

Trial details

NCT IDNCT00342849

SponsorNational Institute of Environmental Health Sciences (NIEHS)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2007-08-29

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