Reducing Iron Content in Infant Formula from 8 to 2 mg/L Does Not Increase the Risk of Iron Deficiency at 4 or 6 Months of Age: A Randomized Controlled Trial.

Maria Björmsjö,Bo Lönnerdal,Staffan K. Berglund,Olle Hernell

doi:10.3390/nu13010003

Maria Björmsjö, Bo Lönnerdal + Show 2 more

Open Access

https://doi.org/10.3390/nu13010003

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Journal: Nutrients	Publication Date: Dec 22, 2020
Citations: 14	License type: CC BY 4.0

Affiliation: Umeå University, University of California, Davis

Abstract

Many infant formulas are fortified with iron at 8–14 mg/L whereas breast milk contains about 0.3 mg/L. Another major difference between breast milk and infant formula is its high concentration of lactoferrin, a bioactive iron-binding protein. The aim of the present study was to investigate how reducing the iron content and adding bovine lactoferrin to infant formula affects iron status, health and development. Swedish healthy full-term formula-fed infants (n = 180) were randomized in a double-blind controlled trial. From 6 weeks to 6 months of age, 72 infants received low-iron formula (2 mg/L) fortified with bovine lactoferrin (1.0 g/L) (Lf+), 72 received low-iron formula un-fortified with lactoferrin (Lf−) and 36 received standard formula with 8 mg of iron/L and no lactoferrin fortification as controls (CF). Iron status and prevalence of iron deficiency (ID) were assessed at 4 and 6 months. All iron status indicators were unaffected by lactoferrin. At 4 and 6 months, the geometric means of ferritin for the combined low-iron groups compared to the CF-group were 67.7 vs. 88.7 and 39.5 vs. 50.9 µg/L, respectively (p = 0.054 and p = 0.056). No significant differences were found for other iron status indicators. In the low-iron group only one infant (0.7%) at 4 months and none at 6 months developed ID. Conclusion: Iron fortification of 2 mg/L is an adequate level during the first half of infancy for healthy term infants in a well-nourished population. Adding lactoferrin does not affect iron status.

Highlights

Breast milk is the optimal source of nutrition for infants during the first months of life, a majority of infants worldwide receive partial or complete feeding with infant formula [1]
The optimal level of iron in infant formula has rarely been evaluated in clinical trials and there is a need for sufficiently powered randomized controlled studies to better determine the appropriate level of iron in infant formula [2]
Infant formulas are highly fortified with iron due to described risks of iron deficiency (ID) and assumed lower absorption of iron from formula compared to breast milk [5,20]

Summary

Introduction

Breast milk is the optimal source of nutrition for infants during the first months of life, a majority of infants worldwide receive partial or complete feeding with infant formula [1]. Iron excess may have toxic, pro-oxidative effects and contrary to the intention to avoid negative physiological manifestations associated with ID; several studies have reported adverse effects of iron supplementation including impaired growth, changed intestinal microbiome with a shift toward increased growth of pathogens, increased risk of infections and even impaired neurodevelopment [4,5,6,7]. The optimal level of iron in infant formula has rarely been evaluated in clinical trials and there is a need for sufficiently powered randomized controlled studies to better determine the appropriate level of iron in infant formula [2]. Another significant difference between breast milk and infant formula is lactoferrin. Apgar score at 5 min Birth weight, kg Birth length, cm

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