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临床试验/NCT05266703
NCT05266703已完成不适用

Defining the Serum Ferritin Concentration in Kenyan Women at Which the Body Senses Iron Depletion and Begins to Upregulate Iron Absorption

Swiss Federal Institute of Technology1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2022年2月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,000
试验地点
1
主要终点
Fractional iron absorption

研究概览

简要总结

The serum or plasma ferritin concentration (referred to hereafter as ferritin) is the most widely used indicator to detect iron deficiency and a low ferritin indicates depleted iron stores. However, the threshold ferritin that defines iron deficiency remains unclear and diagnostic ferritin cutoffs from expert groups vary widely.

Our study aim is to define the ferritin in Kenyan young women at which the body senses iron depletion and begins to upregulate iron absorption from the diet; this approach could provide a functionally defined threshold of iron deficiency in Sub-Saharan African women.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 28 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Age 18-28 y, not pregnant or lactating
  • Body weight <75 kg
  • body mass index (BMI) between 17 and 25 kg/m2
  • No acute illness/infection (self-reported)
  • No metabolic or gastrointestinal disorders (self-reported)
  • No use of medications affecting iron absorption or metabolism during the study
  • No intake of mineral/vitamin supplements 2 weeks prior to the first study visit and during the study

排除标准

  • 未提供

结局指标

主要结局

Fractional iron absorption

时间窗: Day 14

shift in iron isotopic ratios measured in red blood cells

次要结局

  • C-reactive protein(12 months after isotope administration)
  • alpha-1-glycoprotein(12 months after isotope administration)
  • Plasma Ferritin(12 months after isotope administration)
  • soluble transferrin receptor(12 months after isotope administration)
  • Hemoglobin(12 months after isotope administration)
  • Plasma Hepcidin(Day 0)
  • Isotopic composition of red blood cells(12 months after isotope administration)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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