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临床试验/NCT03623997
NCT03623997已完成不适用

Defining Systemic Control of Iron Absorption to Optimize Oral Iron Supplementation Regiemns for Women With Iron Deficiency Anemia

Swiss Federal Institute of Technology1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年10月10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
20
试验地点
1
主要终点
Fractional and total iron absorption

研究概览

简要总结

Iron-deficient anaemic subjects are likely to benefit most from oral iron supplements, but supplementation schedules vary widely in clinical practice, absorption is low and compliance is poor due to mild gastrointestinal side effects. The investigators will compare iron absorption from labeled oral iron doses of 100mg and 200mg administered either on two consecutive days or on alternate days in young anemic women.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Ferritin <15 µg/L
  • Hb 8-11.9 g/dl
  • BMI 18.5-24.9 kg/m2
  • Body weight <70 kg

排除标准

  • Severe anemia (Hb <8 g/dl)
  • Elevated CRP >5.0 mg/L
  • Chronic disease
  • Long-term medication, except contraception
  • Consumption of Mineral and Vitamin supplements within the study period
  • Therapeutic iron infusion over the past 6 months
  • Pregnancy or breastfeeding

结局指标

主要结局

Fractional and total iron absorption

时间窗: absorption will be measured 14days after the 100mg and 200mg cycle

Fractional and total iron absorption from different supplementation regimens

Serum EPO

时间窗: right before the administration of an iron dose

Serum EPO after the administration of different doses and using different

Serum hepcidin

时间窗: right before the administration of an iron dose

Serum hepcidin after the administration of different doses and using different regimens

次要结局

  • Serum ferritin(right before the administration of an iron dose)
  • Serum TfR(right before the administration of an iron dose)
  • Serum CRP(right before the administration of an iron dose)
  • Serum AGP(right before the administration of an iron dose)
  • Serum iron(right before the administration of an iron dose)
  • Total iron binding capacity(right before the administration of an iron dose)

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. med

Swiss Federal Institute of Technology

研究点 (1)

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