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Infant formula iron fortification of 2 vs. 8 mg/L does not increase the risk of iron deficiency or impact

Maria Björmsjö1, Olle Hernell1, Bo Lönnerdal2

  • 1Department of Clinical Sciences, Pediatrics, Umeå University, Umeå, Sweden.

Journal of Pediatric Gastroenterology and Nutrition
|November 27, 2025
PubMed

Insights

Reduced iron infant formula (2 mg/L) adequately supports infant development, with bovine lactoferrin showing no impact on neurodevelopment or growth at 12 months. Iron status indicators were comparable to breastfed infants.

Area of Science:

  • Pediatric Nutrition
  • Infant Formula Development
  • Neurodevelopmental Research

Background:

  • Iron is crucial for infant neurodevelopment and growth.
  • Standard infant formulas contain higher iron concentrations than recommended by some guidelines.
  • Bovine lactoferrin is proposed to enhance iron absorption and possess antimicrobial properties.

Purpose of the Study:

  • To evaluate the effects of reduced iron concentration (2 mg/L) and added bovine lactoferrin in infant formula.
  • To assess neurodevelopment, iron status, and growth at 12 months of age.
  • To compare formula-fed infants with a breastfed reference group.

Main Methods:

  • Randomized controlled trial involving 180 healthy term formula-fed infants.
  • Intervention groups received low-iron formula with or without bovine lactoferrin from 6 weeks to 6 months.
  • Neurodevelopment (BSID-III), iron status, and anthropometrics were assessed at 12 months.

Main Results:

  • No significant differences in neurodevelopment (BSID-III) or prevalence of iron deficiency/anemia were observed.
  • Low-iron formula groups showed lower hepcidin levels and iron status indicators similar to breastfed infants.
  • Head circumference was minimally, but significantly, higher in the low-iron formula group compared to controls.

Conclusions:

  • Infant formula with 2 mg/L iron is adequate for this low-risk population.
  • Bovine lactoferrin supplementation did not influence neurodevelopment, iron status, or growth outcomes.
  • Further research may explore optimal iron concentrations and lactoferrin's role in specific infant populations.
Abstract

Keywords:
Bayley scoresinfant nutritionlactoferrin

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