NCT02103205

Effect of Infant Formula With Bovine Lactoferrin and Low Iron Concentration on Infant Health and Immune Function

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 252 (actual)
• Sponsor: Umeå University · Academic / Other
• Sex: All
• Age: 4 Weeks – 8 Weeks
• Healthy volunteers: Accepted

Summary

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).

Conditions

• Health of Formula-fed Children
• Infant Infections in Formula-fed Children
• Iron Status of Formula-fed Children

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Formula with low iron concentration (2 mg/L) supplemented with bovine lactoferrin
DIETARY_SUPPLEMENT	Formula with low iron concentration (2mg/L) without lactoferrin
DIETARY_SUPPLEMENT	Formula with normal iron concentration (8 mg/L) without lactoferrin

Timeline

• Start date: 2014-06-01
• Primary completion: 2019-05-01
• Completion: 2024-05-01
• First posted: 2014-04-03
• Last updated: 2024-05-16

Locations

1 site across 1 country: Sweden