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临床试验/NCT01687062
NCT01687062已完成不适用

Iron Absorption From Tef-injera in Women of Reproductive Age

Swiss Federal Institute of Technology2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2012年9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
40
试验地点
2
主要终点
Iron absorption

研究概览

简要总结

Anemia is one of the most common health problems all over the world with around half of preschool-aged children (<5 years) and one third of women affected. Nutritional iron deficiency is a major reason for anemia in infants, young children and women of reproductive age who have especially high iron requirements that are difficult to meet in regions where the major diet is based on plant foods. So in Ethiopia, where injera is the major staple food. Despite high levels of iron in tef, the most favored cereal for injera, the iron bioavailability is assumed to be very low due to the high levels of phytic acid found in tef.

The aim of this study is to determine the iron bioavailability in women from injera prepared in a traditional way and investigate the potential of methods to improve the bioavaiability. Therefore, a 50/50 and a 25/75 blend of FeSO4 and NaFeEDTA for iron fortification will be evaluated. Further the potential positive impact of phytic acid reduction on the iron bioavailability will be investigated. The phytic acid reduction will be achieved in two different ways, by addition of whole grain wheat as source of phytase and addition of a commercially available microbial phytase. The studies will be conducted in healthy women using stable isotope techniques.

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
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Reproductive age females 18-40 years
  • Maximum body weight 65 kg
  • Normal body mass index (18.5-25 kg/m2)
  • No intake of mineral/vitamin supplements 2 weeks before and during the study
  • No metabolic or gastrointestinal disorders or chronic diseases
  • Not pregnant or lactating
  • No regular intake of medication (except oral contraceptives)
  • No blood donation or significant blood loss (accident, surgery) over the past 4 months
  • Not currently participating in another clinical trial or having participated in another clinical trial during the last 3 months prior to the beginning of this study
  • No former participation in a study involving administration of iron stable isotopes
  • No eating disorders or food allergy
  • Subject who can be expected and are willing to comply with study protocol
  • Having received oral and written information about the aims and procedures of the study
  • Having provided oral and written informed consent

排除标准

  • 未提供

研究组 & 干预措施

FeSO4 + high phytate

Active Comparator

injera test meal 1 labeled with a 4 mg staple iron isotope tag

干预措施: FeSO4 (Other)

FeSO4 + medium phytate

Experimental

injera test meal 2 labeled with a 4 mg staple iron isotope tag

干预措施: reduction of phytate (Other)

FeSO4 + medium phytate

Experimental

injera test meal 2 labeled with a 4 mg staple iron isotope tag

干预措施: FeSO4 (Other)

FeSO4 + low phytate

Experimental

injera test meal 3 labeled with a 4 mg staple iron isotope tag

干预措施: FeSO4 (Other)

FeSO4 + low phytate

Experimental

injera test meal 3 labeled with a 4 mg staple iron isotope tag

干预措施: reduction of phytate (Other)

FeSO4 + NaFeEDTA (1:1) + high phytate

Experimental

injera test meal 4 labeled with a 4 mg staple iron isotope tag

干预措施: FeSO4 (Other)

FeSO4 + NaFeEDTA (1:1) + high phytate

Experimental

injera test meal 4 labeled with a 4 mg staple iron isotope tag

干预措施: NaFeEDTA (Other)

FeSO4 + NaFeEDTA (1:3) + high phytate

Experimental

injera test meal 5 labeled with a 4 mg staple iron isotope tag

干预措施: FeSO4 (Other)

FeSO4 + NaFeEDTA (1:3) + high phytate

Experimental

injera test meal 5 labeled with a 4 mg staple iron isotope tag

干预措施: NaFeEDTA (Other)

结局指标

主要结局

Iron absorption

时间窗: 17 days

Test meals with isotopic iron labels will be administrated on day 1-3. Whole blood samples will be collected on day 17 (14 after the last test meal) to analyze the iron isotope ratios.

次要结局

未报告次要终点

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)

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