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Absorption of Heme and Non-Heme Iron in Pregnant and Non-pregnant Women and Mechanisms of Fetal Iron Transfer

2012年3月21日更新者：Cornell University

The three specific aims of this study are 1) to assess the impact of iron status on relative differences in absorption of heme and non-heme iron among pregnant women and non-pregnant women, 2) to assess the magnitude and the determinants of heme and non-heme iron transfer to the fetus over the last trimester of pregnancy, and 3) to characterize relationships between placental iron binding proteins with the enrichment of stable iron isotopes in the neonate at birth. The investigators hypothesize that there will be up regulation of heme and non-heme iron absorption and up regulation of placental iron transport proteins in response to low maternal iron stores.

研究概览

地位

完全的

条件

缺铁

详细说明

To measure the absorption of heme and non-heme iron in women, pregnant and non-pregnant women will consume a standardized meal of pork (intrinsically labeled with 58Fe) and a second meal of non-heme 57Fe (as ferrous sulfate). Two weeks after ingesting these test meals, a blood sample will be collected from each women and the amount of heme (58Fe) and non-heme (57Fe) iron incorporated into red blood cells will be measured with magnetic sector thermal ionization mass spectrometry. Cord blood samples and placental tissue will be obtained at delivery to measure how these two forms of dietary iron were transferred across the placenta to the fetus. Maternal and neonatal iron status and placental proteins involved in iron transport will also be measured. Data from this study will provide information that aims to improve human health by better understanding the iron requirements of a population at high risk of iron deficiency.

研究类型

观察性的

注册 (实际的)

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

美国
- New York
  - Rochester、New York、美国、14620
    - Highland Hospital
  - Rochester、New York、美国、14642
    - Strong Memorial Hospital

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

15年至 35年 (孩子、成人)

接受健康志愿者

是的

有资格学习的性别

女性

取样方法

非概率样本

研究人群

Pregnant women and adolescents from Rochester, NY and non-pregnant women from Ithaca, NY.

描述

Inclusion Criteria:

Pregnant subjects (15-35 yrs): non-smoking,healthy with uncomplicated pregnancies at time of enrollment
Non-pregnant subjects (18-35 yrs): healthy, non-smoking, not taking vitamin or mineral supplements and not planning on becoming pregnant during course of study.

Exclusion Criteria:

Pregnant subjects: gestational diabetes, hypertension, preeclampsia, underlying malabsorption diseases or other diagnosed medical problems known to impact iron homeostasis
Non-pregnant subjects: underlying malabsorption diseases or other diagnosed medical problems known to impact iron homeostasis.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

研究衡量的是什么？

主要结果指标

结果测量	大体时间
Heme and Non-Heme Iron Absorption 大体时间：two-weeks post dosing (3rd trimester for pregnant subjects)	two-weeks post dosing (3rd trimester for pregnant subjects)
Heme and Non-Heme Transfer to Fetus 大体时间：Delivery	Delivery

次要结果测量

结果测量	大体时间
Iron Status (serum ferritin, TfR, Total Body Iron, Hb, Hepcidin), Folate, B-12, CRP and EPO in women and neonates 大体时间：two weeks post dosing and at delivery for pregnant subjects	two weeks post dosing and at delivery for pregnant subjects
Protein expression of key iron transport proteins. 大体时间：Delivery	Delivery

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Cornell University

合作者

University of Rochester

调查人员

首席研究员：Kimberly O O'Brien, PhD、Cornell University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2008年5月1日

初级完成 (实际的)

2011年7月1日

研究完成 (实际的)

2011年7月1日

研究注册日期

首次提交

2009年11月24日

首先提交符合 QC 标准的