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PEDIATRICS Vol. 105 No. 3 March 2000, p. e38

ELECTRONIC ARTICLE:
Clinical Safety of Iron-Fortified Formulas

Received Jun 14, 1999; accepted Nov 5, 1999.

Atul Singhal*, Ruth Morley*, Dagger , Rebecca Abbott*, Susan Fairweather-Tait§, Terence Stephensonparallel , and Alan Lucas*

From the * Medical Research Council Childhood Nutrition Research Centre, Institute of Child Health, London, United Kingdom; Dagger  Menzies Center for Population Health Research, Tasmania and Clinical Epidemiology and Biostatisitics Unit, University of Melbourne Department of Pediatrics and Royal Children's Hospital Research Institute, Australia; § Institute of Food Research, Norwich Research Park, Colney, Norwich, Norfolk, United Kingdom; and parallel  Faculty of Medicine and Health Sciences, Academic Division of Child Health, University of Nottingham, United Kingdom.

Background.  Iron-fortified formulas are recommended throughout infancy and are frequently used beyond, yet safety aspects have been inadequately studied. Iron could theoretically increase pro-oxidant stress, with potential adverse effects, including infection risk, and some clinicians suspect that iron-fortified formulas induce gastrointestinal disturbance.

Objective.  A planned component of a large intervention trial has been to test the hypothesis that infants receiving iron-fortified formula do not have a higher incidence of infections (primary outcome) or gastrointestinal problems (secondary outcome) than infants on low iron-formulas or cow's milk.

Methods.  Children (n = 493) 9 months old receiving cow's milk were recruited in 3 UK centers and randomized to: 1) cow's milk as before, 2) formula containing .9 mg/L of iron, or 3) an otherwise identical formula but containing 12 mg/L of iron. Children were followed at 3 monthly intervals and the episodes of infections, diarrhea and constipation, and general morbidity to 18 months old were recorded. Hematologic indices of iron status were determined at 18 months old.

Results.  Serum ferritin concentrations were increased in infants receiving iron-fortified formula but there were no intergroup differences in incidence of infection, gastrointestinal problems, or in general morbidity or weight gain.

Conclusions.  We were unable to identify adverse health effects in older infants and toddlers consuming a high iron-containing formula (12 mg/L) even when used in populations with a low incidence of iron deficiency.  Key words:  iron, formula, infection.




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