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临床试验/NCT01053442
NCT01053442已完成不适用

Absorption, Stable Isotope Appearance and NTBI Profile From NaFeEDTA and Ferrous Sulphate

Swiss Federal Institute of Technology2 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2010年1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
17
试验地点
2
主要终点
Stable iron isotope appearance in the plasma over 8 hours

研究概览

简要总结

Several iron compounds are used for fortification, including ferrous sulphate and NaFeEDTA. The absorption profile of these may differ because of differences in their dissolution in the gastrointestinal tract and in their interaction with dietary inhibitors of iron absorption. As these differences might lead result in varying reactions in the blood stream, the appearance rate of the stable iron isotope, hepcidin, non-transferrin-bound iron and total iron in the plasma will be monitored over six hours in adult women. This is relevant as a spike of absorbed iron may increase non-transferrin-bound iron and this could be pro-oxidative or increase growth of pathogens. Hepcidin is a key mediator of iron absorption and will help explain the potential differences in the plasma iron profile.

The use of stable iron isotope appearance curves to specifically detect the appearance of small amounts of absorbed iron in the blood and distinguish between circulating body iron and iron absorbed from the test meal was tested in a pilot study (EK 2008-23). This method is now used in a bigger sample to test the differences in absorption profile of ferrous sulphate, FePPi and NaFeEDTA given at fortification level with a meal.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Single (Participant)

入排标准

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

入选标准

  • Serum ferritin <60 ug/ l, haemoglobin > 100 g/ l
  • < 65 kg body weight

排除标准

  • Pregnant or lactating
  • Taking iron supplements

结局指标

主要结局

Stable iron isotope appearance in the plasma over 8 hours

时间窗: day 1: 0', 30', 60', 120', 240', 480', day 8 0', 30', 60', 120', 240', 480'

次要结局

  • Isotope incorporation with erythrocytes(day 22)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Michael B. Zimmermann

Prof

Swiss Federal Institute of Technology

研究点 (2)

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