TOXICITY OF LEAD IN CHILDREN--CLINICAL TRIAL

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SUMMARY OF WORK: Exposure to lead in early life produces long-lasting developmental delay. It is not known whether pharmacologically lowering blood lead prevents or ameliorates subsequent delays, and, if it does, whether it can be done with an acceptable degree of safety. The Treatment of Lead-exposed Children (TLC) Trial is a multi-center, placebo-controlled, clinical trial comparing the use of the oral chelating drug succimer with placebo in the prevention of developmental delay, slowed growth, and behavior disorders in toddlers. All children receive home clean up and vitamin and mineral supplementation. Half receive active drug and halfplacebo. Enrollment of children began in August 1994 and all 780 children were randomized by January, 1997. The children were between 12 and 32 months of age, and have blood lead levels between 20 and 44 micrograms per deciliter. All children will be followed for 3 years, and their development and behavior measured. The trial is designed on the assumptions that peak blood leads, achieved in the US by children at about age 2 years, cause developmental delays in children 4 years old and older, and that succimer will lower blood leads in the range of eligibility of the trial. Mean blood lead in the randomized children is 26 micrograms per deciliter, and the treatment goal is 15 micrograms per deciliter. A 10 microgram per deciliter change in blood lead is expected to result in a 3 point difference in measured IQ. The trial has a statistical power of about .8 to detect a 3 point difference. TLC also measures other aspects of development, as well as blood pressure, height, and behavior. - chelation; lead poisoning, child development; clinical trials; dimercaptosuccinic acid; succimer - Human Subjects