跳至主要内容
临床试验/NCT02979080
NCT02979080Unknown不适用

The Evaluation of Iron Supplementation and Iron Requirements Using a Novel Isotope Dilution Method in Beninese Women

Prof. Michael B. Zimmermann2 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2017年6月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
63
试验地点
2
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 potential reference method to quantify iron absorption and requirements using isotope dilution measurements in women living in areas with high burden of infection should be developed and validated within this project. The new method will allow accurate measurement of long term oral iron absorption and the estimation of iron requirements, potentially providing fundamental guidance for supplementation and fortification programs in sub-Saharan Africa. In a case series with four months' preventative iron supplementation intervention imbedded between a four months' control period prior intervention and a four months' control period after intervention, we will follow a group of 63 women. During the intervention period, the women will receive 50 mg Fe as ferrous sulfate tablets every day for 120 d. In total, the women will give 9 blood samples (day 1, 60 120, 150, 180, 210, 240, 300 and 360) for the de-termination of the isotopic composition and iron status biomarkers and 5 stool samples (day 1, 120, 180, 240 and 360) for the detection of soil transmitted helminths and gut inflammation. This design will allow the measurement of the isotopic iron dilution to assess the total oral iron absorption during the intervention period in comparison with the control periods without the administration of additional iron isotopes.

研究设计

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

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Oral Iron Supplementation

Experimental

Eisensulfat LOMAPHARM 50 mg administration for 120 days

干预措施: Eisensulfat LOMAPHARM 50 mg (Other)

结局指标

主要结局

iron isotope composition in blood

时间窗: 1 year

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 (2)

Loading locations...

相似试验