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Recall of a lead-contaminated vitamin and mineral supplement in a clinical trial

✍ Scribed by Walter J. Rogan; N. Beth Ragan; Andrew I. Damokosh; Cecilia Davoli; Thomas R. Shaffer; Robert L. Jones; Sherry Wilkens; Marian C. Heenehan; James H. Ware; Fred Henretig

Publisher
John Wiley and Sons
Year
1999
Tongue
English
Weight
124 KB
Volume
8
Category
Article
ISSN
1053-8569

No coin nor oath required. For personal study only.

✦ Synopsis

Purpose Ð The Treatment of Lead-exposed Children (TLC) trial tested whether developmental outcome diered between children treated for lead poisoning with succimer or placebo. On 7 July 1997, TLC was informed that the vitamin and mineral supplements it gave to all children were contaminated with about 35 mg of lead per tablet.

Methods Ð TLC recalled the contaminated supplements and measured the children's exposure.

Results Ð The families of 96% of the children were contacted with 30 days. Among the 571 children to whom the contaminated supplements were dispensed, the mean increase in blood lead was 0.06+0.01 mmol/L (1.2+0.2 mg/dL); among 78 children to whom they were not, it was 0.09+0.03 mmol/L (1.8+0.7 mg/dL). There was no evidence of a dose-response relation between estimated supplement consumption and increase in blood lead concentration.

Conclusions Ð The children's blood lead concentrations were not detectably aected by the contamination. Since the association of cognitive delay with lead exposure is best described for blood lead, we believe that the trial's inference about the eect of drug therapy on lead induced cognitive delay should be unaected.

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