A POPULATION - BASED STUDY OF CHILDREN EXPOSED TO CHLORIDE DEFICIENT FORMULA

Abstract

In 1978 and 1979 Syntex, Inc. manufactured two soy-based infant formulas which lacked adequate chloride. A number of small studies have suggested that children who ingested these formulas may have suffered long-term adverse effects secondary to this exposure. However, these studies involves relatively few subjects who were selected in a fashion subject to substantial bias. This study ascertained the infant formulas used by the first and second graders attending public school in one county in the Southeastern United States. Children who were exposed to a defective infant formula were matched to two children who ingested chloride-sufficient soy-based formulas as infants. Matching variables included age, race, sex, socioeconomic status and birth weight. All children (n=108) received a standarized test of intellectual ability, the McCarthy Scales, which were administered by an examiner blinded to the exposure status of each child. Significant adjusted mean differences between the score on the General Cognitive Index (diff.=5.7, one-tailed p=.05) and the Quantitative Scale (diff.=3.1, one-tailed p<.05) were documented with the exposed children scoring lower than their matched controls. Decrements in the performance of exposed children were noted on the Perceptual-Performance (diff.=3.2. one-tailed p<.15) and Motor (diff.=3.3, one-tailed p<.1) Scales although these were not statistically significant. These data reinforce concern about the long-term outcome of children exposed to these formulas.

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