Erythroferrone and Its Impact on Maternal and Neonatal Iron Homeostasis

March 8, 2022 updated by: Cornell University
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.

Study Overview

Status

Completed

Study Type

Observational

Enrollment (Actual)

338

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New York
      • Rochester, New York, United States, 14609
        • Rochester Adolescent Maternity Program
      • Rochester, New York, United States, 14620
        • Strong Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 43 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Pregnant Adolescents
Pregnant Women Carrying Multiple Fetuses

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maternal Erythroferrone During Pregnancy
Time Frame: Measures will be obtained from maternal blood collected throughout the 40 weeks of pregnancy
Measures will be obtained from maternal blood collected throughout the 40 weeks of pregnancy
Maternal Erythroferrone at Delivery
Time Frame: Measures will be obtained from maternal blood collected at delivery
Measures will be obtained from maternal blood collected at delivery
Neonatal Erythroferrone at Birth
Time Frame: Measures will be obtained from umbilical cord blood collected at delivery
Measures will be obtained from umbilical cord blood collected at delivery
Placental Erythroferrone mRNA and Ferroportin protein Expression
Time Frame: Measures will be obtained from placental samples collected at delivery
Measures will be obtained from placental samples collected at delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Elizabeta Nemeth, PhD, University of California, Los Angeles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2006

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

August 11, 2020

First Submitted That Met QC Criteria

August 17, 2020

First Posted (Actual)

August 18, 2020

Study Record Updates

Last Update Posted (Actual)

March 22, 2022

Last Update Submitted That Met QC Criteria

March 8, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0911001050

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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