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Completed

NCT Number: NCT01019096

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

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.

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Key information

Age range

15 year–35 year

Sex eligibility

Female

Study type

Observational

Primary location

Highland Hospital, Rochester, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Heme and Non-Heme Iron Absorption

    Time frame: two-weeks post dosing (3rd trimester for pregnant subjects)

  2. Heme and Non-Heme Transfer to Fetus

    Time frame: Delivery

Secondary outcomes

  1. Iron Status (serum ferritin, TfR, Total Body Iron, Hb, Hepcidin), Folate, B-12, CRP and EPO in women and neonates

    Time frame: two weeks post dosing and at delivery for pregnant subjects

  2. Protein expression of key iron transport proteins.

    Time frame: Delivery

Sponsors and collaborators

Lead sponsor

Cornell University

Other

Collaborators

  • University of Rochester

Registry information

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Nov 25, 2009
Registry last updated
Mar 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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