Risk of diarrhea related to iron content of infant formula: lack of evidence to support the use of low-iron formula as a supplement for breastfed infants.

BACKGROUND Concern has been raised by infant feeding experts that supplementing breastfed infants with iron-fortified formula rather than low-iron formula may have an undesirable impact on their gastrointestinal flora. Thus far, there have been no clinical studies to address this issue directly. We compared the reported frequency of diarrhea for breastfed infants given iron-fortified formula with those fed low-iron formula. METHODS Mothers participating in a mail panel provided feeding and diarrhea information on their infants at 2, 3, 4, 5, 6, 7, 9, and 12 months (n = 1743). Infants were grouped into five feeding categories: (1) breast milk only, (2) breast milk and low-iron formula, (3) breast milk and iron-fortified formula, (4) low-iron formula only, and (5) iron-fortified formula only. We calculated the number of diarrheal episodes per week for each feeding category and used rate ratios to estimate the relative impact of low-iron and iron-fortified formulas. RESULTS Among infants who received both breast milk and formula, the rate ratio for iron-fortified formula versus low-iron formula was 1.06 (confidence interval, 0.84 to 1.34), indicating that the type of formula a breastfed infant receives does not significantly affect the frequency of diarrhea. CONCLUSIONS We found no evidence to support the hypothesis that breastfed infants given iron-fortified formula are at greater risk of having diarrhea. This, in addition to the fact that iron-fortified formula has played a major role in preventing childhood iron deficiency anemia, supports the current recommendation that any formula given to infants be fortified with iron.