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OpenTrials
Completed

NCT Number: NCT04517734

Erythroferrone and Its Impact on Maternal and Neonatal Iron Homeostasis

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.

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Key information

Conditions

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

Age range

11 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Rochester Adolescent Maternity Program, Rochester, New York, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Maternal Erythroferrone During Pregnancy

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

  2. Maternal Erythroferrone at Delivery

    Time frame: Measures will be obtained from maternal blood collected at delivery

  3. Neonatal Erythroferrone at Birth

    Time frame: Measures will be obtained from umbilical cord blood collected at delivery

  4. Placental Erythroferrone mRNA and Ferroportin protein Expression

    Time frame: Measures will be obtained from placental samples collected at delivery

Sponsors and collaborators

Lead sponsor

Cornell University

Other

Collaborators

  • University of California, Los Angeles

Registry information

Important dates

Study start
2006
Primary completion
2017
Study completion
2017
First posted
Aug 18, 2020
Registry last updated
Mar 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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