Clinical trial NCT01019096: Absorption of Heme and Non-Heme Iron in Pregnant and Non-pregnant Women and Mechanisms of Fetal Iron Transfer
Official title: Absorption of Heme and Non-Heme Iron in Pregnant and Non-pregnant Women and Mechanisms of Fetal Iron Transfer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Iron Deficiency
Keywords: iron
pregnancy
heme iron
non-heme iron
stable isotopes
women/adolescents
Lead sponsor: Cornell University
Sponsor class: OTHER
Collaborators: name: University of Rochester
First posted: 2009-11-25
Enrollment: 55
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women and adolescents from Rochester, NY and non-pregnant women from Ithaca, NY.

Brief summary: 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.

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 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.

Primary outcomes:
measure: Heme and Non-Heme Iron Absorption
timeFrame: two-weeks post dosing (3rd trimester for pregnant subjects)
measure: Heme and Non-Heme Transfer to Fetus
timeFrame: Delivery
Secondary outcomes:
measure: Iron Status (serum ferritin, TfR, Total Body Iron, Hb, Hepcidin), Folate, B-12, CRP and EPO in women and neonates
timeFrame: two weeks post dosing and at delivery for pregnant subjects
measure: Protein expression of key iron transport proteins.
timeFrame: Delivery
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Highland Hospital
state: New York
city: Rochester
country: United States
facility: Strong Memorial Hospital
state: New York
Study officials:
affiliation: Cornell University
name: Kimberly O O'Brien, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Rochester
name: Eva Pressman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Young MF, Griffin I, Pressman E, McIntyre AW, Cooper E, McNanley T, Harris ZL, Westerman M, O'Brien KO. Maternal hepcidin is associated with placental transfer of iron derived from dietary heme and nonheme sources. J Nutr. 2012 Jan;142(1):33-9. doi: 10.3945/jn.111.145961. Epub 2011 Nov 23.
citation: Young MF, Griffin I, Pressman E, McIntyre AW, Cooper E, McNanley T, Harris ZL, Westerman M, O'Brien KO. Utilization of iron from an animal-based iron source is greater than that of ferrous sulfate in pregnant and nonpregnant women. J Nutr. 2010 Dec;140(12):2162-6. doi: 10.3945/jn.110.127209. Epub 2010 Oct 27.
citation: Young MF, Pressman E, Foehr ML, McNanley T, Cooper E, Guillet R, Orlando M, McIntyre AW, Lafond J, O'Brien KO. Impact of maternal and neonatal iron status on placental transferrin receptor expression in pregnant adolescents. Placenta. 2010 Nov;31(11):1010-4. doi: 10.1016/j.placenta.2010.08.009. Epub 2010 Sep 15.
citation: Delaney KM, Guillet R, Pressman EK, Caulfield LE, Zavaleta N, Abrams SA, O'Brien KO. Iron absorption during pregnancy is underestimated when iron utilization by the placenta and fetus is ignored. Am J Clin Nutr. 2020 Sep 1;112(3):576-585. doi: 10.1093/ajcn/nqaa155.