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Completed

NCT Number: NCT02103205

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

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).

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Key information

Conditions

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

Age range

4 week–8 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Umeå University, Department of Clinical Sciences

Umeå, SE-901 87, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

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

Dietary Supplement

Primary outcomes

  1. Incidence of infections

    Time frame: Up to 12 months of age

    Morbidity journal, Health questionnaire

  2. Cytokine levels

    Time frame: At 6 months of age

    IL-2, TNF-alpha

  3. Iron status

    Time frame: At 6 months of age

    s-ferritin, s-transferrin, s-iron, s-transferrin receptor concentration, reticulocyte Hb

Secondary outcomes

  1. Dietary intake

    Time frame: At baseline, 3, 4, 5, 6 and 12 months of age

    Dietary journal

  2. Growth

    Time frame: At baseline, 4, 6, 12 months of age and 6 years of age

    Anthropometric data, Body Composition (PeaPod)

  3. Bloodpressure

    Time frame: At baseline, 4, 6, 12 months of age and 6 years of age

  4. Antibody response to vaccines

    Time frame: At baseline, 4, 6 and 12 months of age

    s-levels of specific antibodies to vaccines (DTP, Hib, PC)

  5. Gut microbiota

    Time frame: At baseline, 4, 6, 12 months of age and 6 years of age

    Stool samples

  6. Saliva proteins

    Time frame: At 4 months of age

    Saliva total protein content, lactoferrin, saliva-peroxidase, IgA and amylase

  7. Inflammatory markers

    Time frame: At baseline, 4, 6 and 12 months of age and 6 years age

    s-hsCRP, s-calprotectin

  8. Cognitive development and behavior

    Time frame: At 1 and 6 years of age

    Bayley III, Wechsler Intelligence Scale for Children (WISC), Behavioral questionnaire

  9. s-hepcidin

    Time frame: At baseline, 4, 6, 12 months of age and 6 years of age

  10. Metabolomics

    Time frame: At baseline, 4, 6, 12 months of age and 6 years of age

    Analyzed in urine and serum samples

  11. Amino acids

    Time frame: At 4 and 6 months of age

    p-amino acids

  12. Blood urea nitrogen

    Time frame: At 4 and 6 months of age

    p-urea nitrogen

  13. Cytokine levels

    Time frame: 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.

  14. Iron status

    Time frame: 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

Other outcomes

  1. Lactoferrin in breastmilk

    Time frame: At baseline, 4 and 6 months of age

    Analyzed from mothers to the control group of breast fed infants.

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Collaborators

  • Mead Johnson Nutrition
  • University of California

Registry information

Acronym: LIME

Important dates

Study start
2014
Primary completion
2019
Study completion
2025
First posted
Apr 3, 2014
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.