Clinical trial NCT02103205: Effect of Infant Formula With Bovine Lactoferrin and Low Iron Concentration on Infant Health and Immune Function
Official title: Effect of Infant Formula With Bovine Lactoferrin and Low Iron Concentration on Infant Health and Immune Function
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Health of Formula-fed Children
Infant Infections in Formula-fed Children
Iron Status of Formula-fed Children
Keywords: Lactoferrin
Infant formula
Iron
Lead sponsor: Umeå University
Sponsor class: OTHER
Collaborators: name: University of California
name: Mead Johnson Nutrition
First posted: 2014-04-03
Enrollment: 252
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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).


Eligibility criteria: Inclusion Criteria:

Formula-fed healthy infants at 6 +/- 2 weeks of age with:

* birth weight 2500-4500 g
* gestational age at birth ≥ 37 completed weeks
* no chronic disease or neonatal diagnoses believed to affect any outcome
* no given blood transfusions or iron supplements

Exclusion Criteria:

-

Primary outcomes:
measure: Incidence of infections
timeFrame: Up to 12 months of age
measure: Cytokine levels
timeFrame: At 6 months of age
measure: Iron status
timeFrame: At 6 months of age
Secondary outcomes:
measure: Dietary intake
timeFrame: At baseline, 3, 4, 5, 6 and 12 months of age
measure: Growth
timeFrame: At baseline, 4, 6, 12 months of age and 6 years of age
measure: Bloodpressure
timeFrame: At baseline, 4, 6, 12 months of age and 6 years of age
measure: Antibody response to vaccines
timeFrame: At baseline, 4, 6 and 12 months of age
measure: Gut microbiota
timeFrame: At baseline, 4, 6, 12 months of age and 6 years of age
measure: Saliva proteins
timeFrame: At 4 months of age
measure: Inflammatory markers
timeFrame: At baseline, 4, 6 and 12 months of age and 6 years age
measure: Cognitive development and behavior
timeFrame: At 1 and 6 years of age
measure: s-hepcidin
timeFrame: At baseline, 4, 6, 12 months of age and 6 years of age
measure: Metabolomics
timeFrame: At baseline, 4, 6, 12 months of age and 6 years of age
measure: Amino acids
timeFrame: At 4 and 6 months of age
measure: Blood urea nitrogen
timeFrame: At 4 and 6 months of age
measure: Cytokine levels
timeFrame: At baseline, 4, 6, 12 months of age and 6 years of age
measure: Iron status
timeFrame: At baseline, 4 and 12 months of age and 6 years of age
Other outcomes:
measure: Lactoferrin in breastmilk
timeFrame: At baseline, 4 and 6 months of age
Locations:
city: Umeå
country: Sweden
facility: Umeå University, Department of Clinical Sciences
Study officials:
affiliation: Umeå University
name: Staffan K Berglund, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Umeå University
name: Olle Hernell, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California
name: Bo Lönnerdal, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California
name: Carolyn Slupsky, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bjormsjo M, Hernell O, Lonnerdal B, Berglund SK. Immunological Effects of Adding Bovine Lactoferrin and Reducing Iron in Infant Formula: A Randomized Controlled Trial. J Pediatr Gastroenterol Nutr. 2022 Mar 1;74(3):e65-e72. doi: 10.1097/MPG.0000000000003367.