跳至主要内容
临床试验/NCT02255942
NCT02255942已完成不适用

The Effect of Zinc on Iron Bioavailability From Fortified Extruded Rice Fortified With Ferric Pyrophosphate

Swiss Federal Institute of Technology2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2015年4月最近更新:
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
20
试验地点
2
主要终点
Change from baseline in the isotopic ratio of iron in blood at week 2

研究概览

简要总结

Investigation of Iron Bioavailability from extruded rice grains fortified with Ferric Pyrophosphate alone or in combination with different Zinc Compounds; Ferrous Sulfate serves as a Reference.

详细描述

Ferric Pyrophosphate (FePP) is a water-insoluble, food grade, iron compound widely used to fortify rice and other foods as it causes no organoleptic changes to the food vehicles. However, it is only of low absorption in man and its absorption can be influenced by a variety of compounds. The effect of co-fortification of rice with ZnO respectively ZnSO4 on iron bioavailability in extruded rice fortified with FePP has never been investigated.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
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

入选标准

  • Serum Ferritin Level < 15 µg/L
  • Body weight <65 kg
  • Signed informed consent
  • Body Mass Index in the range of 18.5 to 25

排除标准

  • 未提供

研究组 & 干预措施

Iron fortified rice

Experimental

Administration of iron fortified rice to all subjects; subjects will act as their own controls and each subject will receive all foreseen treatments/interventions.

干预措施: Ferric Pyrophosphate (Other)

Iron fortified rice

Experimental

Administration of iron fortified rice to all subjects; subjects will act as their own controls and each subject will receive all foreseen treatments/interventions.

干预措施: Ferrous sulfate (Other)

Iron fortified rice

Experimental

Administration of iron fortified rice to all subjects; subjects will act as their own controls and each subject will receive all foreseen treatments/interventions.

干预措施: Ferric Pyrophosphate and Zinc Sulfate (Other)

Iron fortified rice

Experimental

Administration of iron fortified rice to all subjects; subjects will act as their own controls and each subject will receive all foreseen treatments/interventions.

干预措施: Ferric Pyrophosphate and Zinc Oxide (Other)

结局指标

主要结局

Change from baseline in the isotopic ratio of iron in blood at week 2

时间窗: baseline, 2 weeks

The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.

Change from week 2 in the isotopic ratio of iron in blood at week 4

时间窗: 2 weeks, 4 weeks

The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.

Change from week 4 in the isotopic ratio of iron in blood at week 6

时间窗: 4 weeks, 6 weeks

The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.

次要结局

  • Haemoglobin(baseline, 16th, 30th and 44th day)
  • C reactive protein(baseline, 16th, 30th and 44th day)
  • Plasma Ferritin(baseline, 16th, 30th and 44th day)

研究者

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

Prof. Michael B. Zimmermann

Prof.Dr.

Swiss Federal Institute of Technology

研究点 (2)

Loading locations...

相似试验