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

Not Applicable

Active, not recruiting

• Conditions: Health of Formula-fed Children; Infant Infections in Formula-fed Children; Iron Status of Formula-fed Children
• Interventions: Dietary Supplement: Formula with low iron concentration (2mg/L) without lactoferrin; Dietary Supplement: Formula with normal iron concentration (8 mg/L) without lactoferrin; Dietary Supplement: Formula with low iron concentration (2 mg/L) supplemented with bovine lactoferrin

• Registration Number: NCT02103205
• Lead Sponsor: Umeå University

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-31
• Study First Submitted QC: 2014-03-31
• Study First Posted: 2014-04-03
• Study Start: 2014-06
• Primary Completion: 2019-05
• Status Verified: 2024-05
• Study Completion: 2024-05
• Last Update Submitted: 2024-05-15
• Last Update Posted: 2024-05-16

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 252

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low iron, no lactoferrin	Formula with low iron concentration (2mg/L) without lactoferrin	Low iron, no lactoferrin
Normal iron, no lactoferrin	Formula with normal iron concentration (8 mg/L) without lactoferrin	Normal iron, no lactoferrin
Low iron, with lactoferrin	Formula with low iron concentration (2 mg/L) supplemented with bovine lactoferrin	Low iron, with lactoferrin

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Antibody response to vaccines	At baseline, 4, 6 and 12 months of age	s-levels of specific antibodies to vaccines (DTP, Hib, PC)
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
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
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
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.

Trial Locations

Locations (1)

Umeå University, Department of Clinical Sciences; 🇸🇪 Umeå, Sweden