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Erythroferrone and Its Impact on Maternal and Neonatal Iron Homeostasis

Sponsor
Cornell University (Other)
Overall Status
Completed
CT.gov ID
NCT04517734
Collaborator
University of California, Los Angeles (Other)
338
Enrollment
2
Locations
140
Actual Duration (Months)
169
Patients Per Site
1.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    338 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Erythroferrone and Its Impact on Maternal and Neonatal Iron Homeostasis
    Actual Study Start Date :
    Apr 1, 2006
    Actual Primary Completion Date :
    Dec 1, 2017
    Actual Study Completion Date :
    Dec 1, 2017

    Arms and Interventions

    Arm Intervention/Treatment
    Pregnant Adolescents
    Pregnant Women Carrying Multiple Fetuses

    Outcome Measures

    Primary Outcome Measures

    1. Maternal Erythroferrone During Pregnancy [Measures will be obtained from maternal blood collected throughout the 40 weeks of pregnancy]

    2. Maternal Erythroferrone at Delivery [Measures will be obtained from maternal blood collected at delivery]

    3. Neonatal Erythroferrone at Birth [Measures will be obtained from umbilical cord blood collected at delivery]

    4. Placental Erythroferrone mRNA and Ferroportin protein Expression [Measures will be obtained from placental samples collected at delivery]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    11 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rochester Adolescent Maternity Program Rochester New York United States 14609
    2 Strong Memorial Hospital Rochester New York United States 14620

    Sponsors and Collaborators

    • Cornell University
    • University of California, Los Angeles

    Investigators

    • Principal Investigator: Kimberly O'Brien, PhD, Cornell University
    • Principal Investigator: Elizabeta Nemeth, PhD, University of California, Los Angeles

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cornell University
    ClinicalTrials.gov Identifier:
    NCT04517734
    Other Study ID Numbers:
    • 0911001050
    First Posted:
    Aug 18, 2020
    Last Update Posted:
    Mar 22, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Anemia

    Study Results

    No Results Posted as of Mar 22, 2022