Effect of Infant Formula With Bovine Lactoferrin and Low Iron Concentration on Infant Health and Immune Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 252
- 试验地点
- 2
- 主要终点
- Incidence of infections
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Weeks 至 8 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
Low iron, with lactoferrin
Low iron, with lactoferrin
干预措施: Formula with low iron concentration (2 mg/L) supplemented with bovine lactoferrin (Dietary Supplement)
Low iron, no lactoferrin
Low iron, no lactoferrin
干预措施: Formula with low iron concentration (2mg/L) without lactoferrin (Dietary Supplement)
Normal iron, no lactoferrin
Normal iron, no lactoferrin
干预措施: Formula with normal iron concentration (8 mg/L) without lactoferrin (Dietary Supplement)
结局指标
主要结局
Incidence of infections
时间窗: Up to 12 months of age
Morbidity journal, Health questionnaire
Cytokine levels
时间窗: At 6 months of age
IL-2, TNF-alpha
Iron status
时间窗: At 6 months of age
s-ferritin, s-transferrin, s-iron, s-transferrin receptor concentration, reticulocyte Hb
次要结局
- Antibody response to vaccines(At baseline, 4, 6 and 12 months of age)
- 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)
- Gut microbiota(At baseline, 4, 6, 12 months of age and 6 years of age)
- Saliva proteins(At 4 months of age)
- Inflammatory markers(At baseline, 4, 6 and 12 months of age and 6 years age)
- Cognitive development and behavior(At 1 and 6 years of age)
- 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)
- Amino acids(At 4 and 6 months of age)
- Blood urea nitrogen(At 4 and 6 months of age)
- Iron status(At baseline, 4 and 12 months of age and 6 years of age)
- Cytokine levels(At baseline, 4, 6, 12 months of age and 6 years of age)