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

This study has been completed.
Sponsor:
Collaborator:
University of Rochester
Information provided by (Responsible Party):
Cornell University
ClinicalTrials.gov Identifier:
NCT01019096
First received: November 24, 2009
Last updated: March 21, 2012
Last verified: March 2012
  Purpose

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.


Condition
Iron Deficiency

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Absorption of Heme and Non-Heme Iron in Pregnant and Non-pregnant Women and Mechanisms of Fetal Iron Transfer

Resource links provided by NLM:


Further study details as provided by Cornell University:

Primary Outcome Measures:
  • Heme and Non-Heme Iron Absorption [ Time Frame: two-weeks post dosing (3rd trimester for pregnant subjects) ] [ Designated as safety issue: No ]
  • Heme and Non-Heme Transfer to Fetus [ Time Frame: Delivery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Protein expression of key iron transport proteins. [ Time Frame: Delivery ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

For non-pregnant subjects 15 mL of blood are collected. For pregnant subjects two 15 mL blood samples are collected. The placenta and up to 30 mL of cord blood are also collected at delivery.


Enrollment: 55
Study Start Date: May 2008
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   15 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01019096

Locations
United States, New York
Strong Memorial Hospital
Rochester, New York, United States, 14642
Highland Hospital
Rochester, New York, United States, 14620
Sponsors and Collaborators
Cornell University
University of Rochester
Investigators
Principal Investigator: Kimberly O O'Brien, PhD Cornell University
Principal Investigator: Eva Pressman, MD University of Rochester
  More Information

Publications:
Responsible Party: Cornell University
ClinicalTrials.gov Identifier: NCT01019096     History of Changes
Other Study ID Numbers: 06-06-045, 2006-07-160
Study First Received: November 24, 2009
Last Updated: March 21, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Cornell University:
iron
pregnancy
heme iron
non-heme iron
stable isotopes
women/adolescents

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014