Erythroferrone and Its Impact on Maternal and Neonatal Iron Homeostasis

Pregnancy Anemia Clinical Trial

Official title:

Erythroferrone and Its Impact on Maternal and Neonatal Iron Homeostasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04517734
• Other study ID #: 0911001050
• Status: Completed
• Start date: April 2006
• Est. completion date: December 2017

Study information

• Verified date: March 2022
• Source: Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 338
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 11 Years to 45 Years

Eligibility

Inclusion Criteria:

• Healthy pregnant volunteers

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Anemia
• Newborn; Anemia
• Pregnancy Anemia

Locations

Country	Name	City	State
United States	Rochester Adolescent Maternity Program	Rochester	New York
United States	Strong Memorial Hospital	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
Cornell University	University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal Erythroferrone During Pregnancy		Measures will be obtained from maternal blood collected throughout the 40 weeks of pregnancy
Primary	Maternal Erythroferrone at Delivery		Measures will be obtained from maternal blood collected at delivery
Primary	Neonatal Erythroferrone at Birth		Measures will be obtained from umbilical cord blood collected at delivery
Primary	Placental Erythroferrone mRNA and Ferroportin protein Expression		Measures will be obtained from placental samples collected at delivery