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临床试验/NCT00386074
NCT00386074已完成2 期

The Efficacy of Iron Fortified Whole Maize Flour on the Iron Status of School Children in Kenya

Wageningen University0 个研究点目标入组 412 人开始时间: 2004年5月最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
412
主要终点
Plasma Transferrin receptor

研究概览

简要总结

The purpose of this study is to assess whether NaFeEDTA and electrolytic iron improve iron status of young school children, when added as iron fortificants in whole maize flour.

详细描述

Fortification of staple foods with iron may be an effective method of addressing the problem of iron deficiency. Questions however remain of the type of iron fortificants to use, the appropriate fortification levels and suitable food vehicles. Cereals form attractive vehicles because they are widely consumed in parts of the world that bear a large burden of the iron deficiency problem. They are however high in phytates and would reduce the bioavailability of commonly used iron fortificants. Isotope studies have shown that even in the presence of phytates, iron from NaFeEDTA is relatively more bioavailable than that from other fortificant sources. Its efficacy has however not been assessed in human trials. Electrolytic iron, on the other hand is widely used and was legislated as the iron fortificant of choice in South Africa. Its efficacy in a high-phytate vehicle has also not been assessed. We have therefore undertaken to assess the efficacy of NaFeEDTA at two doses, as an iron fortificant in whole flour, and the efficacy of electrolytic iron at a dose similar to the high-dose NaFeEDTA. The results will contribute information on the suitability of these fortificants in whole maize flour, a food commonly consumed in sub-Saharan Africa.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double

入排标准

年龄范围
3 Years 至 8 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 3-8 years age (for the purposes of this study this will include children born within the period December 15th 1995- May 1st 2001).
  • Whohave been resident in the area for 6 months or more.
  • Enrolled in the selected schools
  • Able to consume the target amount of porridge, at least 50% of the time during the run-in period
  • Will be present in the study area for the entire study period (April - December 2004).

排除标准

  • Children below 3 years and above 8 years of age (born after December 15th 1995 and before May 1st 2001).
  • Children who have been resident in the area for less than 6 months at the time of recruitment.
  • Children with obvious physical and mental disability.
  • Severely malnourished children.
  • Severely anaemic children (Hb <70g/L).

结局指标

主要结局

Plasma Transferrin receptor

Haemoglobin

Plasma Ferritin

次要结局

  • Iron deficiency anaemia
  • Anaemia
  • Iron deficiency

研究者

申办方类型
Other

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