Erythroferrone and Its Impact on Maternal and Neonatal Iron Homeostasis

NCT04517734 | Completed

• 1 other identifier: 0911001050
• Study Type: observational
• Target: 338
• Locations: 1 country
• Sites: 2

Brief Summary

Erythroferrone (ERFE) is a recently identified iron-regulatory hormone that couples iron homeostasis to erythropoiesis but at this time there are no human data on this hormone in pregnant women and their neonates. The investigators hypothesize that ERFE is a sensitive biomarker of iron deficiency and anemia in pregnancy and neonates, and that it mediates the feedback mechanism to correct iron deficiency and anemia. To address this research gap, the investigators will measure ERFE in maternal serum, umbilical cord serum and placental tissue using an existing biospecimen archive.

Conditions

Pregnancy Anemia; Newborn; Anemia

Outcome Measures

Primary Outcomes (4)

• Maternal Erythroferrone During Pregnancy

  Measures will be obtained from maternal blood collected throughout the 40 weeks of pregnancy

• Maternal Erythroferrone at Delivery

  Measures will be obtained from maternal blood collected at delivery

• Neonatal Erythroferrone at Birth

  Measures will be obtained from umbilical cord blood collected at delivery

• Placental Erythroferrone mRNA and Ferroportin protein Expression

  Measures will be obtained from placental samples collected at delivery

Study Arms (2)

Pregnant Adolescents

Pregnant Women Carrying Multiple Fetuses

Eligibility Criteria

• Age: 11 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women carrying multiple fetuses (twins, triplets and quadruplets) or pregnant adolescents carrying a single fetus

You may qualify if:

• Healthy pregnant volunteers

You may not qualify if:

• Hemoglobinopathies
• Pre-existing diabetes
• Malabsorption diseases
• Pregnancy induced hypertension
• Elevated diastolic blood pressure (\>110)
• Previous treatment for lead exposure or elevated childhood lead concentrations.
• Preexisting medical conditions known to impact iron homeostasis

Sponsors & Collaborators

• Cornell University: lead
• University of California, Los Angeles: collaborator

Study Sites (2)

Rochester Adolescent Maternity Program

Rochester, New York, 14609, United States

Location

Strong Memorial Hospital

Rochester, New York, 14620, United States

Location

Related Publications (1)

• Delaney KM, Guillet R, Pressman EK, Ganz T, Nemeth E, O'Brien KO. Serum Erythroferrone During Pregnancy Is Related to Erythropoietin but Does Not Predict the Risk of Anemia. J Nutr. 2021 Jul 1;151(7):1824-1833. doi: 10.1093/jn/nxab093.

  PMID: 33982118 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

During pregnancy 15 mL maternal blood sample collected. At delivery 15 mL maternal blood sample, 20 mL umbilical cord blood sample and the placenta are collected.

MeSH Terms

Conditions

Anemia, Neonatal

Condition Hierarchy (Ancestors)

Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Kimberly O'Brien, PhD

  Cornell University

  PRINCIPAL INVESTIGATOR

• Elizabeta Nemeth, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 11, 2020
• First Posted: August 18, 2020
• Study Start: April 1, 2006
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: March 22, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)