Iron Absorption From Iron-fortified Infant Formula and Iron Drops in Infants (MJAU-studien)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- iron absorption
研究概览
简要总结
Iron deficiency (ID) affects up to 25% of Swedish infants and severe ID is associated with cognitive and behavioral problems. To avoid this, iron supplements or iron-fortified infant foods are recommended for infants. However, the optimal iron dose and mode of delivery have not yet been established. This is a concern as excessive iron intake may impair growth and increase morbidity in iron-sufficient infants. Previous studies have suggested that iron-fortified foods may have different effects than iron supplements. In this study, the investigators will investigate whether the mode of iron administration (supplementation vs. fortification) and the amount consumed (high intakes vs. low intakes) affect iron absorption, iron utilization, and zinc absorption in healthy term non-iron-deficient 6-month-old infants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 7 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •6-7 months of age at the start of intervention
- •healthy at enrollment
- •full-term (>37 gestational weeks at birth)
- •birth weight >2500 g
- •predominantly bottle-fed at recruitment
排除标准
- •iron deficiency at enrollment
- •previous or current use of iron supplements
结局指标
主要结局
iron absorption
时间窗: 1 month after enrollment
次要结局
- indicators of iron metabolism, growth, and oxidative stress(1 month and 1.5 months after enrollment)
- zinc absorption(1 month after enrollment)