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临床试验/NCT01264042
NCT01264042已完成不适用

Iron Supplementation During Pregnancy and Non-Transferrin-Bound Iron (NTBI)

Swiss Federal Institute of Technology2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2011年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
NTBI

研究概览

简要总结

Although the essential role of iron during pregnancy is well established, concerns have been raised that current iron supplements given routinely during pregnancy may also have harmful consequences, such as increased oxidative stress and enhanced risks of infection, pre-eclampsia and impaired glucose regulation. A potential mechanism for the production of adverse effects is the appearance of non-transferrin-bound iron after oral administration of iron supplements. Non-transferrin-bound iron is more readily available to pathogens and could promote injurious free radical reactions that might add to the oxidative stress of pregnancy.

The present study will determine if oral administration of 60 mg of iron as ferrous sulfate during the second trimester of pregnancy is followed by the appearance of non-transferrin-bound iron two hours later. The investigators will examine the influence of a variety of factors, including iron status and previous use of iron supplements. Detection of non-transferrin-bound iron after administration of an iron supplement to pregnant women would be an important new observation that could lead to re-evaluation of current methods of iron supplementation.

研究设计

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

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

  • Pregnant woman
  • Age 18 to 45 years
  • singleton pregnancy
  • between 24 and 28 of gestation (at study day)
  • regular visits at prenatal clinic
  • capability and willingness to comply with study protocol
  • voluntary signed informed consent

排除标准

  • Multiple pregnancy
  • Acute or chronic disease or disorder
  • Incapability of following the study protocol
  • Homelessness
  • Active drug/alcohol dependence or abuse history
  • Currently participating in another clinical trial or having participated in another clinical trial during the last 3 months prior to the beginning of this study

结局指标

主要结局

NTBI

时间窗: Change between baseline and 2 hours

The primary variables are NTBI values determined at baseline and two hours after the intake of 60 mg ferrous sulfate, which will allow to determine the effect of the iron supplement on NTBI formation.

次要结局

  • Iron Status and History of Iron Supplements(baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Michael B. Zimmermann

Prof.

Swiss Federal Institute of Technology

研究点 (2)

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