Iron and the Breast-Fed Infant: Iron Status and Two Regimens of Iron Supplementation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 171
- 试验地点
- 2
- 主要终点
- Iron status
研究概览
简要总结
Normal breastfed infants can develop iron deficiency by 6 months of age. This trial tested the hypothesis that regular provision of a source of iron beginning at 4 months of age improves iron status and could prevent iron deficiency. This was a prospective randomized trial involving breastfed infants. To be eligible, infants had to be predominantly breastfed (<200 ml/day of formula) at 4 months of age. At 4 months infants were randomly assigned to one of two interventions or to control. The interventions consisted in the daily administration of medicinal iron in a dose of 7.5 mg (Medicinal Iron Group) or in the daily feeding of one jar of an iron-fortified cereal providing 7 mg of iron each day (Cereal Group). The control group received complementary foods chosen by he parents but no source of iron provided by the investigators. The interventions took place from 4 to 9 months. All infants were subsequently followed to 2 years of age.
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
- None
入排标准
- 年龄范围
- 1 Month 至 24 Months(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Predominantly breastfed (at 4 months) term infants
排除标准
- •Not predominantly breastfed at 4 months
- •Premature infants
结局指标
主要结局
Iron status
时间窗: 3 times during the intervention
次要结局
- Growth(At the end of intervention)
- Tolerance (gastrointestinal)(During intervention)
