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临床试验/NCT02977806
NCT02977806Unknown不适用

The Evaluation of Iron Metabolism Using a Novel Isotope Dilution Method in Malawian Children, Who Have Previously Participated in a Stable Isotope Study

Prof. Michael B. Zimmermann1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2017年3月27日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
48
试验地点
1
主要终点
iron isotope composition in blood

研究概览

简要总结

Conventional indirect indicators of iron status, using serum and red blood cell biomarkers, are confounded by inflammation from common infections in sub-Saharan Africa, a region with a high prevalence of iron deficiency, making the assessment of iron balance and efficiency of iron intervention difficult. A new method allowing accurate measurement of long-term oral iron absorption and allowing the estimation of iron requirements is highly needed. Such a novel method to quantify iron absorption and requirements using isotope dilution measurements in children should be validated in the present prospective observational study by following-up a group of 49 children given a stable iron isotope in an earlier trial. We will request seven blood samples within 2 years (sampling every four months) from the participants which will allow us to measure isotopic dilution for estimating total oral iron absorption over these 24 months.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
3 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Have participated in the original absorption study and the two follow-up samplings
  • Signed written informed consent from the guardian to participate in the study

排除标准

  • Long-term medication
  • Any severe metabolic, gastrointestinal kidney or chronic disease such as diabetes, hepatitis, hypertension, cancer or cardiovascular diseases (according to the guardian's statement or med-ical examination (health booklet))
  • Blood losses (surgery, accident) or blood transfusion during the past 4 months before study start.
  • Residence too far away (> 2 hours by motorbike) from study location (Zomba)

结局指标

主要结局

iron isotope composition in blood

时间窗: 2 years

the iron isotope ratio (tracer/tracee ratio) in blood should be analyzed with ICPMS every 120 days

次要结局

未报告次要终点

研究者

发起方
Prof. Michael B. Zimmermann
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Prof. Michael B. Zimmermann

Professor

Swiss Federal Institute of Technology

研究点 (1)

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