Erythroferrone and Its Impact on Maternal and Neonatal Iron Homeostasis

NCT ID: NCT04517734

Last Updated: 2022-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

338 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-04-30

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pregnancy Anemia Newborn; Anemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pregnant Adolescents

No interventions assigned to this group

Pregnant Women Carrying Multiple Fetuses

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

11 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, Los Angeles

OTHER

Sponsor Role collaborator

Cornell University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kimberly O'Brien, PhD

Role: PRINCIPAL_INVESTIGATOR

Cornell University

Elizabeta Nemeth, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

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Rochester Adolescent Maternity Program

Rochester, New York, United States

Site Status

Strong Memorial Hospital

Rochester, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 33982118 (View on PubMed)

Other Identifiers

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0911001050

Identifier Type: -

Identifier Source: org_study_id

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