a1 Institute of Child Health, University of Birmingham, Whittal Street, Birmingham B4 6NH, UK
The purpose of this review is to examine the need for and appropriate level of Fe fortification of infant formula, and to assess any adverse effects of Fe fortification. The appropriate level of Fe fortification of infant formula has been established through studies of Fe absorption or erythrocyte incorporation of Fe, and through clinical trials of formulas with varying levels of Fe that were aimed at preventing the development of Fe deficiency in participating infants. In addition, the effects of varying levels of Fe fortification on the absorption of other minerals and trace elements, and on the incidence of infection and immune function have been studied, as has the effect of adding bovine lactoferrin to formula. Studies of Fe absorption have shown that increasing the level of Fe fortification in formula does not significantly increase the amount absorbed, and that the addition of bovine lactoferrin is unlikely to further increase absorption of Fe. Quite different recommendations for the level of Fe fortification of formula are made in the USA and in Europe. The higher level (12 mg/l) commonly used in the USA is not well supported by the evidence from clinical trials that suggest that lower levels (4 mg/l or less) may be adequate to prevent the development of Fe deficiency. Higher levels of Fe fortification may also interfere with the absorption of other minerals such as Cu and Se. Concerns about potential adverse effects of Fe fortification on immune function and susceptibility to infections have been disproved as have concerns about associated gastrointestinal symptomatology. There are no clearly demonstrated advantages in using ‘follow-on’ formula with high Fe content (up to 13 mg/l) instead of the standard UK formulas with Fe fortification in the range 4–7 mg/l after the age of 6 months, although they may provide an important ‘safety net’ for the prevention of Fe deficiency in communities with weaning diets low in Fe.
* Prepared for the Standing Committee on Nutrition, Royal College of Paediatrics and Child Health.