Iron status of breastfed infants is improved equally by medicinal iron and iron-fortified cereal.

Background: Although uncommon, iron deficiency (ID) occurs in breastfed infants. The regular provision of iron may prevent ID.

Objective: The objective was to test the feasibility and effectiveness of 2 modalities of providing iron (medicinal iron or iron-fortified cereal) to breastfed infants. The study tested the hypothesis that regular provision of iron improves iron status of breastfed infants without adverse effects.

Design: In this prospective, randomized, open-label trial, breastfed infants received on a regular basis either medicinal iron (n = 48) or an iron-fortified fruit-cereal combination (n = 45) from 4 to 9 mo or no intervention (control group; n = 59). The interventions provided 7.0-7.5 mg ferrous sulfate/d. Infants were enrolled at 1 mo and were followed to 2 y. Iron-status indicators were determined periodically, stool characteristics were recorded, and growth was monitored.

Results: The regular provision of iron led to improved iron status during and for some months after the intervention. Both sources of iron were about equally effective. Iron affected stool color but had no effect on feeding-related behavior. However, medicinal iron was associated with a small but significant reduction in length gain and a trend toward reduced weight gain. ID anemia was observed in 4 infants (2.3%), most of whom had a low birth iron endowment. Mild ID was common in the second year of life.

Conclusions: Regular provision of medicinal iron or iron-fortified cereal improves the iron status of breastfed infants and may prevent ID. Both modalities are equally effective, but medicinal iron leads to somewhat reduced growth. This trial was registered at ClinicalTrials.gov as NCT00760890.