Health of Formula-fed Children, Infant Infections in Formula-fed Children, Iron Status of Formula-fed Children
Conditions
Keywords
Lactoferrin, Infant formula, Iron
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).
Interventions
DIETARY_SUPPLEMENTFormula with low iron concentration (2 mg/L) supplemented with bovine lactoferrin
DIETARY_SUPPLEMENTFormula with low iron concentration (2mg/L) without lactoferrin
DIETARY_SUPPLEMENTFormula with normal iron concentration (8 mg/L) without lactoferrin
Sponsors
Umeå University
University of California
Mead Johnson Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Weeks to 8 Weeks
Healthy volunteers
Yes
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
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of infections | Up to 12 months of age | Morbidity journal, Health questionnaire |
| Cytokine levels | At 6 months of age | IL-2, TNF-alpha |
| Iron status | At 6 months of age | s-ferritin, s-transferrin, s-iron, s-transferrin receptor concentration, reticulocyte Hb |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dietary intake | At baseline, 3, 4, 5, 6 and 12 months of age | Dietary journal |
| Growth | At baseline, 4, 6, 12 months of age and 6 years of age | Anthropometric data, Body Composition (PeaPod) |
| Bloodpressure | At baseline, 4, 6, 12 months of age and 6 years of age | — |
| Antibody response to vaccines | At baseline, 4, 6 and 12 months of age | s-levels of specific antibodies to vaccines (DTP, Hib, PC) |
| Gut microbiota | At baseline, 4, 6, 12 months of age and 6 years of age | Stool samples |
| Saliva proteins | At 4 months of age | Saliva total protein content, lactoferrin, saliva-peroxidase, IgA and amylase |
| Inflammatory markers | At baseline, 4, 6 and 12 months of age and 6 years age | s-hsCRP, s-calprotectin |
| Cognitive development and behavior | At 1 and 6 years of age | Bayley III, Wechsler Intelligence Scale for Children (WISC), Behavioral questionnaire |
| s-hepcidin | At baseline, 4, 6, 12 months of age and 6 years of age | — |
| Metabolomics | At baseline, 4, 6, 12 months of age and 6 years of age | Analyzed in urine and serum samples |
| Amino acids | At 4 and 6 months of age | p-amino acids |
| Blood urea nitrogen | At 4 and 6 months of age | p-urea nitrogen |
| Cytokine levels | At baseline, 4, 6, 12 months of age and 6 years of age | 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. |
| Iron status | At baseline, 4 and 12 months of age and 6 years of age | s-ferritin, s-transferrin, s-iron, s-transferrin saturation, s-transferrin receptor concentration, retuiculocyte Hb |
Countries
Sweden
Contacts
PRINCIPAL_INVESTIGATORStaffan K Berglund, MD, PhD
Umeå University
PRINCIPAL_INVESTIGATOROlle Hernell, Professor
Umeå University
PRINCIPAL_INVESTIGATORBo Lönnerdal, Professor
University of California
PRINCIPAL_INVESTIGATORCarolyn Slupsky, PhD
University of California
Outcome results
None listed