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

NCT02103205 | Active Not Recruiting

• 1 other identifier: LIME2014
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

Lactoferrin; Infant formula; Iron

Outcome Measures

Primary Outcomes (3)

• Incidence of infections

  Morbidity journal, Health questionnaire

  Up to 12 months of age

• Cytokine levels

  IL-2, TNF-alpha

  At 6 months of age

• Iron status

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

  At 6 months of age

Secondary Outcomes (14)

• Dietary intake

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

• Growth

  At baseline, 4, 6, 12 months of age and 6 years of age

• 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

• Gut microbiota

  At baseline, 4, 6, 12 months of age and 6 years of age

Other Outcomes (1)

• Lactoferrin in breastmilk

  At baseline, 4 and 6 months of age

Study Arms (3)

Low iron, with lactoferrin

ACTIVE COMPARATOR

Low iron, with lactoferrin

Dietary Supplement: Formula with low iron concentration (2 mg/L) supplemented with bovine lactoferrin

Low iron, no lactoferrin

ACTIVE COMPARATOR

Low iron, no lactoferrin

Dietary Supplement: Formula with low iron concentration (2mg/L) without lactoferrin

Normal iron, no lactoferrin

PLACEBO COMPARATOR

Normal iron, no lactoferrin

Dietary Supplement: Formula with normal iron concentration (8 mg/L) without lactoferrin

Interventions

Formula with low iron concentration (2 mg/L) supplemented with bovine lactoferrin DIETARY_SUPPLEMENT

Low iron, with lactoferrin

Formula with low iron concentration (2mg/L) without lactoferrin DIETARY_SUPPLEMENT

Low iron, no lactoferrin

Formula with normal iron concentration (8 mg/L) without lactoferrin DIETARY_SUPPLEMENT

Normal iron, no lactoferrin

Eligibility Criteria

• Age: 4 Weeks - 8 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

Sponsors & Collaborators

• Umeå University: lead
• University of California: collaborator
• Mead Johnson Nutrition: collaborator

Study Sites (1)

Umeå University, Department of Clinical Sciences

Umeå, SE-901 87, Sweden

Location

Related Publications (1)

• 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.

  PMID: 34908015 DERIVED

MeSH Terms

Interventions

Food, Formulated; Lactoferrin

Intervention Hierarchy (Ancestors)

Foods, Specialized; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Glycoproteins; Glycoconjugates; Carbohydrates; Transferrins; Iron-Binding Proteins; Carrier Proteins; Proteins; Amino Acids, Peptides, and Proteins; Lactoglobulins; Whey Proteins; Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Globulins; Metalloproteins

Study Officials

• Staffan K Berglund, MD, PhD

  Umeå University

  PRINCIPAL INVESTIGATOR

• Olle Hernell, Professor

  Umeå University

  PRINCIPAL INVESTIGATOR

• Bo Lönnerdal, Professor

  University of California

  PRINCIPAL INVESTIGATOR

• Carolyn Slupsky, PhD

  University of California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: March 31, 2014
• First Posted: April 3, 2014
• Study Start: June 1, 2014
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-05

Locations

SE (1)