Evidence map›Paper›PMID 41307188›Full record

Trial reportJournal of pediatric gastroenterology and nutrition2026

Infant formula iron fortification of 2 vs. 8 mg/L does not increase the risk of iron deficiency or impact neurodevelopment at 12 months.

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

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of pediatric gastroenterology and nutrition, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Trial
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Maria BjörmsjöDepartment of Clinical Sciences, Pediatrics, Umeå University, Umeå, Sweden.
Olle HernellDepartment of Clinical Sciences, Pediatrics, Umeå University, Umeå, Sweden.
Bo LönnerdalDepartment of Nutrition, University of California, Davis, California, USA.
Staffan K BerglundDepartment of Clinical Sciences, Pediatrics, Umeå University, Umeå, Sweden.ORCID https://orcid.org/0000-0002-9263-9578

Funding

Knut and Alice Wallenberg FoundationOskar Foundation and the KEMPE FoundationUmeå University and Västerbotten County Council (ALF)
6 · The paper itself

Abstract

objectivesThe aim of this follow-up was to investigate how reduced iron concentration and added bovine lactoferrin in infant formula affect neurodevelopment, iron status, and growth at 12 months of age.

methodsSwedish healthy term formula-fed infants (n = 180) were randomly assigned to receive, from 6 weeks to 6 months of age, a low-iron formula (2 mg/L) fortified with bovine lactoferrin (1.0 g/L) (Lf+, n = 72), the same formula without lactoferrin fortification (Lf-, n = 72) or a control standard formula with 8 mg/L and no lactoferrin (CF, n = 36). Breast-fed infants were recruited as a reference (n = 72). At 12 months of age, Bayley Scales of Infant and Toddler Development-III (BSID-III), iron status, and anthropometrics were assessed.

resultsThere were no intervention effects on BSID-III. Explored outcomes were unaffected by lactoferrin and the two low-iron groups (Lf+ and Lf-) were combined. The low-iron group had lower hepcidin (37.8 vs. 49.4 ng/mL, p = 0.027), compared to the CF group. Furthermore, they had iron status indicators more similar to the breast-fed reference group. The prevalence of iron deficiency (ID) and iron deficiency anemia (IDA) was low with no significant differences among groups. Weight and length were unaffected by intervention, however head circumference was minimally higher in infants fed low-iron formula compared to CF with mean difference (95% confidence interval) of 0.3 (0.0-0.6) standard-deviation-scores, p = 0.03.

conclusionsInfant formula iron concentration at 2 mg/L was adequate in this population of infants with low risk of ID. Adding bovine lactoferrin did not affect the explored long-term clinical outcomes.

Indexed as

Anemia, Iron-DeficiencyChild DevelopmentFood, FortifiedInfant FormulaIronIron, DietaryLactoferrinAnimalsCattleFemaleFollow-Up StudiesHumansInfantInfant Nutritional Physiological PhenomenaIron DeficienciesMaleIronIron, DietaryLactoferrinBayley scoresinfant nutritionlactoferrin

Identifiers

PMID41307188
PMCPMC12864171

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.