An interventional study of Formula with low iron concentration (2 mg/L) supplemented with bovine lactoferrin and Formula with low iron concentration (2mg/L) without lactoferrin in Health of Formula-fed Children, Infant Infections in Formula-fed Children and Iron Status of Formula-fed Children, sponsored by Umeå University. Completed at 1 site in Sweden. Open to participants aged 4 Weeks to 8 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-28.
Sponsored by Umeå University · Not applicable, Interventional, and Prevention
Breast milk is the gold standard of early infant nutrition and breastfed infants have advantages in several short and long term outcomes compared to those formula-fed.
The first aim of this study is to evaluate the effect of adding bovine lactoferrin to infant formula. The general hypothesis is that bovine lactoferrin reduces some of the previously observed differences between formula-fed and breast-fed infants with regard to health and development. The main outcome studied is the effect on immune function. The second aim is to study the effects of lower iron concentration in infant formula and to test the hypothesis that iron can be lowered without negative effects on health and development. The main outcome studied here is iron status. Other outcomes in this trial are microbiota composition, metabolomics, growth, body composition and cognitive development.
To test the lactoferrin hypothesis, formula-fed infants will be recruited and fed a low iron (2 mg/L) control formula, or the same formula supplemented with bovine lactoferrin. To test the iron hypothesis, a third group will be fed the same formula (no lactoferrin) with higher iron concentration (8 mg/L). Group allocation for all formula-fed infants will be double-blind randomized. Additionally, breast-fed infants will be recruited and used as a reference group (gold standard).
Umeå University is the lead sponsor of 263 studies on the registry; 60 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Formula-fed healthy infants at 6 +/- 2 weeks of age with:
Exclusion Criteria:
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Low iron, with lactoferrin
Dietary Supplement: Formula with low iron concentration (2 mg/L) supplemented with bovine lactoferrin
Low iron, no lactoferrin
Dietary Supplement: Formula with low iron concentration (2mg/L) without lactoferrin
Normal iron, no lactoferrin
Dietary Supplement: Formula with normal iron concentration (8 mg/L) without lactoferrin
Incidence of infections
Morbidity journal, Health questionnaire
Time frame: Up to 12 months of age
Cytokine levels
IL-2, TNF-alpha
Time frame: At 6 months of age
Iron status
s-ferritin, s-transferrin, s-iron, s-transferrin receptor concentration, reticulocyte Hb
Time frame: At 6 months of age
Dietary intake
Dietary journal
Time frame: At baseline, 3, 4, 5, 6 and 12 months of age
Growth
Anthropometric data, Body Composition (PeaPod)
Time frame: At baseline, 4, 6, 12 months of age and 6 years of age
Bloodpressure
Time frame: At baseline, 4, 6, 12 months of age and 6 years of age
Antibody response to vaccines
s-levels of specific antibodies to vaccines (DTP, Hib, PC)
Time frame: At baseline, 4, 6 and 12 months of age
Gut microbiota
Stool samples
Time frame: At baseline, 4, 6, 12 months of age and 6 years of age
Saliva proteins
Saliva total protein content, lactoferrin, saliva-peroxidase, IgA and amylase
Time frame: At 4 months of age
Inflammatory markers
s-hsCRP, s-calprotectin
Time frame: At baseline, 4, 6 and 12 months of age and 6 years age
Cognitive development and behavior
Bayley III, Wechsler Intelligence Scale for Children (WISC), Behavioral questionnaire
Time frame: At 1 and 6 years of age
s-hepcidin
Time frame: At baseline, 4, 6, 12 months of age and 6 years of age
Metabolomics
Analyzed in urine and serum samples
Time frame: At baseline, 4, 6, 12 months of age and 6 years of age
Amino acids
p-amino acids
Time frame: At 4 and 6 months of age
Blood urea nitrogen
p-urea nitrogen
Time frame: At 4 and 6 months of age
Cytokine levels
IL-2 and TNF alpha at baseline, 4 and 12 months of age and 6 years of age. Six additional cytokines at baseline, 4, 6 and 12 months of age and 6 years of age.
Time frame: At baseline, 4, 6, 12 months of age and 6 years of age
Iron status
s-ferritin, s-transferrin, s-iron, s-transferrin saturation, s-transferrin receptor concentration, retuiculocyte Hb
Time frame: At baseline, 4 and 12 months of age and 6 years of age
Lactoferrin in breastmilk
Analyzed from mothers to the control group of breast fed infants.
Time frame: At baseline, 4 and 6 months of age
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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