Effect of Infant Formula With Bovine Lactoferrin and Low Iron Concentration on Infant Health and Immune Function
NCT ID: NCT02103205
Last Updated: 2024-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
252 participants
INTERVENTIONAL
2014-06-30
2024-05-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Low iron, with lactoferrin
Low iron, with lactoferrin
Formula with low iron concentration (2 mg/L) supplemented with bovine lactoferrin
Low iron, no lactoferrin
Low iron, no lactoferrin
Formula with low iron concentration (2mg/L) without lactoferrin
Normal iron, no lactoferrin
Normal iron, no lactoferrin
Formula with normal iron concentration (8 mg/L) without lactoferrin
Interventions
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Formula with low iron concentration (2 mg/L) supplemented with bovine lactoferrin
Formula with low iron concentration (2mg/L) without lactoferrin
Formula with normal iron concentration (8 mg/L) without lactoferrin
Eligibility Criteria
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Inclusion Criteria
* 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
4 Weeks
8 Weeks
ALL
Yes
Sponsors
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University of California
OTHER
Mead Johnson Nutrition
INDUSTRY
Umeå University
OTHER
Responsible Party
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Staffan Berglund
MD, PhD
Principal Investigators
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Staffan K Berglund, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Umeå University
Olle Hernell, Professor
Role: PRINCIPAL_INVESTIGATOR
Umeå University
Bo Lönnerdal, Professor
Role: PRINCIPAL_INVESTIGATOR
University of California
Carolyn Slupsky, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California
Locations
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Umeå University, Department of Clinical Sciences
Umeå, , Sweden
Countries
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References
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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.
Other Identifiers
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LIME2014
Identifier Type: -
Identifier Source: org_study_id
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