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临床试验/NCT00760890
NCT00760890已完成不适用

Iron and the Breast-Fed Infant: Iron Status and Two Regimens of Iron Supplementation

National Institutes of Health (NIH)2 个研究点 分布在 1 个国家目标入组 171 人开始时间: 2001年6月最近更新:
适应症

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

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)

研究者

申办方类型
Nih

研究点 (2)

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