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

NCT01019096 | Completed DMC

• 2 other identifiers: 06-06-0452006-07-160
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 2

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.

Conditions

Iron Deficiency

Keywords

iron; pregnancy; heme iron; non-heme iron; stable isotopes; women/adolescents

Outcome Measures

Primary Outcomes (2)

• Heme and Non-Heme Iron Absorption

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

• Heme and Non-Heme Transfer to Fetus

  Delivery

Secondary Outcomes (2)

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

  two weeks post dosing and at delivery for pregnant subjects

• Protein expression of key iron transport proteins.

  Delivery

Eligibility Criteria

• Age: 15 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cornell University: lead
• University of Rochester: collaborator

Study Sites (2)

Highland Hospital

Rochester, New York, 14620, United States

Location

Strong Memorial Hospital

Rochester, New York, 14642, United States

Location

Related Publications (4)

• 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.

  PMID: 22113871 RESULT

• 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.

  PMID: 20980658 RESULT

• 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.

  PMID: 20828813 RESULT

• 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.

  PMID: 32614379 DERIVED

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.

MeSH Terms

Conditions

Iron Deficiencies

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Kimberly O O'Brien, PhD

  Cornell University

  PRINCIPAL INVESTIGATOR

• Eva Pressman, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2009
• First Posted: November 25, 2009
• Study Start: May 1, 2008
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: March 22, 2012

Record last verified: 2012-03

Locations

US (2)