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
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
- 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
- 是
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
研究组 & 干预措施
Isotopically labelled iron sulfate 15mg
Other
干预措施: Isotopically labelled iron sulfate 15mg (Other)
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
- Plasma Ferritin(12 months after isotope administration)
- soluble transferrin receptor(12 months after isotope administration)
- C-reactive protein(12 months after isotope administration)
- alpha-1-glycoprotein(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)
- soluble transferrin receptor(4 months after isotope administration)
- soluble transferrin receptor(8 months after isotope administration)
- C-reactive protein(Day 0)
- C-reactive protein(4 months after isotope administration)
- C-reactive protein(8 months after isotope administration)
- alpha-1-glycoprotein(Day 0)
- alpha-1-glycoprotein(4 months after isotope administration)
- alpha-1-glycoprotein(8 months after isotope administration)
- Hemoglobin(Day 0)
- Hemoglobin(4 months after isotope administration)
- Plasma Ferritin(4 months after isotope administration)
- Plasma Ferritin(8 months after isotope administration)
- soluble transferrin receptor(Day 0)
- Plasma Ferritin(Day 0)
- Hemoglobin(8 months after isotope administration)
- Isotopic composition of red blood cells(4 months after isotope administration)
- Isotopic composition of red blood cells(8 months after isotope administration)
研究者
研究点 (1)
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