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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
Umeå universitet, Medicinska fakulteten, Institutionen för klinisk vetenskap, Pediatrik.
Umeå universitet, Medicinska fakulteten, Institutionen för klinisk vetenskap, Pediatrik.ORCID-id: 0000-0001-8841-6200
Umeå universitet, Medicinska fakulteten, Institutionen för klinisk vetenskap, Pediatrik. Umeå universitet, Medicinska fakulteten, Wallenberg centrum för molekylär medicin vid Umeå universitet (WCMM).ORCID-id: 0000-0002-9263-9578
2021 (Engelska)Ingår i: Nutrients, E-ISSN 2072-6643, Vol. 13, nr 1, artikel-id 3Artikel i tidskrift (Refereegranskat) Published
Abstract [en]

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 mu g/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.

Ort, förlag, år, upplaga, sidor
MDPI, 2021. Vol. 13, nr 1, artikel-id 3
Nyckelord [en]
infants, iron supplementation, iron fortification, infant formula, iron status, iron depletion, iron deficiency, iron deficiency anemia, growth, gastrointestinal symptoms
Nationell ämneskategori
Pediatrik
Identifikatorer
URN: urn:nbn:se:umu:diva-180157DOI: 10.3390/nu13010003ISI: 000610643900001PubMedID: 33374970Scopus ID: 2-s2.0-85098619407OAI: oai:DiVA.org:umu-180157DiVA, id: diva2:1530424
Tillgänglig från: 2021-02-22 Skapad: 2021-02-22 Senast uppdaterad: 2023-08-28Bibliografiskt granskad
Ingår i avhandling
1. Clinical effects of reduced iron content and fortification with bovine lactoferrin in infant formula
Öppna denna publikation i ny flik eller fönster >>Clinical effects of reduced iron content and fortification with bovine lactoferrin in infant formula
2023 (Engelska)Doktorsavhandling, sammanläggning (Övrigt vetenskapligt)
Alternativ titel[sv]
Kliniska effekter vid minskat järninnehåll och tillägg av bovint laktoferrin i modersmjölksersättning
Abstract [en]

Background: Breast milk, with its complex, individual and over time adapting composition, is considered the optimal source of nutrition for infants during the first months of life. Two possible contributing factors to the benefits of breastfeeding compared to infant formula-feeding are the differences in iron and lactoferrin (Lf) concentrations between breast milk and infant formula. The overall purpose of the LIME (a Swedish acronym) study was to add knowledge on how to reduce the gap in health and development between breastfed and formula-fed infants. The aim of this double-blinded controlled trial, and doctoral thesis, was to investigate how added bovine lactoferrin and reduced iron concentration in infant formula affect health and development.

Methods: Recruitment took place from June 2014 to June 2018. With equal gender distribution, healthy term Swedish formula-fed infants (n=180) were randomly assigned, from 6 weeks to 6 months of age, to receive a low iron formula (2 mg/L) with bovine Lf (1.0 g/L) (Lf+, n=72), a low iron formula without Lf (Lf-, n=72) or a control standard formula with 8 mg/L iron and no Lf (CF, n=36). Additionally, 72 breastfed infants were recruited as a reference (BF) group. Blood samples were drawn at 4, 6, and 12 months. Primary outcomes were cytokine levels and iron status. Secondary outcomes were growth, gastrointestinal symptoms, infection-related morbidity and treatments, antibody response to vaccines and cognitive development.

Findings: All explored outcomes were unaffected by Lf fortification and the two low iron groups (Lf+ and Lf-) were combined and compared to the CF group. At 6 months of age the TGF-β2 levels were lower among the low iron groups and more similar to the BF infants. No other significant differences in cytokine levels were observed. There was a trend of lower geometric mean of ferritin at 4, 6, and 12 months for the combined low iron groups compared to the CF group (67.7 vs 88.7, 39.5 vs 50.9, and 20.5 vs 25.1 μg/L, respectively, p=0.054, p=0.056, and p=0.082). No similar trends or significant differences were found for any of the other iron status indicators, except for hepcidin at 12 months with lower levels in the low iron group compared to CF (37.8 vs 49.4 ng/mL, p=0.027). Overall, infants fed low iron formula had iron status indicators closer to the breastfed reference group and the prevalence of iron deficiency (ID) and iron deficiency anemia (IDA) was generally low with no significant differences among the intervention groups.

There were no clinically relevant effects of the interventions on growth, gastrointestinal symptoms, infection-related morbidity, vaccine antibody response or neurocognitive development.

In secondary analyses, the present study confirmed previous results of higher cognitive scores among breastfed infants compared to formula-fed and observed an unexpected lower IgG response to vaccines against Hib and Diphtheria.

Conclusion: Adding bovine lactoferrin did not affect any of the clinical outcomes explored. Lowering infant formula iron concentration from 8 to 2 mg/L minimally reduced iron stores to levels closer to breastfed infants but did not increase the risk of ID/IDA during the first year of life. Consequently, 2 mg/L is a sufficient level of iron fortification during the first six months of life in a population with low risk of ID. Both adjustments are considered safe with no observed adverse effects.

Ort, förlag, år, upplaga, sidor
Umeå: Umeå universitet, 2023. s. 88
Serie
Umeå University medical dissertations, ISSN 0346-6612 ; 2230
Nyckelord
infant formula, lactoferrin, bovine lactoferrin, iron, iron supplementation, iron fortification, iron status, infant nutrition, cytokines, neurodevelopment, vaccine response, infection-related morbidity
Nationell ämneskategori
Pediatrik
Forskningsämne
pediatrik
Identifikatorer
urn:nbn:se:umu:diva-204950 (URN)978-91-8070-001-6 (ISBN)978-91-8070-002-3 (ISBN)
Disputation
2023-03-17, Hörsal D, by 1D, målpunkt T, 9 tr, Norrlands universitetssjukhus, Umeå, 09:00 (Engelska)
Opponent
Handledare
Tillgänglig från: 2023-02-24 Skapad: 2023-02-17 Senast uppdaterad: 2023-02-27Bibliografiskt granskad

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Björmsjö, MariaHernell, OlleBerglund, Staffan K.

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