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

Umeå University

Status: Active, not recruiting

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

Treatments: 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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02103205

LIME2014

Details and patient eligibility

About

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).

Enrollment: 252 patients

Sex: All

Ages: 4 to 8 weeks old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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252 participants in 3 patient groups, including a placebo group

Low iron, with lactoferrin

Active Comparator group

Description:

Low iron, with lactoferrin

Treatment:

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

Low iron, no lactoferrin

Active Comparator group

Description:

Low iron, no lactoferrin

Treatment:

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

Normal iron, no lactoferrin

Placebo Comparator group

Description:

Normal iron, no lactoferrin

Treatment:

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