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临床试验/NCT01404533
NCT01404533已完成不适用

The Influence of Iron Interventions on Formation of Non-transferrin-bound Iron (NTBI) in Women

Swiss Federal Institute of Technology1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2009年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
1
主要终点
Formation of NTBI following oral iron administration

研究概览

简要总结

The overall goal of this research is to develop safe and effective iron interventions that can be administered without production of plasma non-transferrin-bound iron (NTBI: iron in the systemic circulation not bound to the iron-transport protein transferrin). The appearance of plasma non-transferrin-bound iron has been reported in uninfected adult volunteers after oral administration of iron supplements in doses similar to those used in the Pemba trial. This research project will (i) confirm the appearance of plasma non-transferrin-bound iron after administration of an iron supplement like that in the Pemba trial (~1 mg Fe/kg body weight, without food), and then determine the effects on production of plasma non-transferrin-bound iron and on iron absorption measured with stable isotopes (ii) of giving the supplemental iron (~1 mg Fe/kg) with the standard rice meal, and (iii) of giving a lower dose of iron (~0.1 mg Fe/kg) - like that used in home fortification - with the standard rice meal.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •non pregnant
  • •non lactating
  • •apparently healthy women

排除标准

  • •chronic disease
  • •pregnancy
  • •lactation

研究组 & 干预措施

Iron supplement with food

Experimental

干预措施: Ferrous sulfate (Dietary Supplement)

Iron supplement without food

Experimental

干预措施: Ferrous sulfate (Dietary Supplement)

Iron fortificant with food

Experimental

干预措施: Ferrous sulfate (Dietary Supplement)

结局指标

主要结局

Formation of NTBI following oral iron administration

时间窗: 6 time points within 8 hours

次要结局

  • Serum iron isotope appearance curves(6 time points within 8 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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