Pregnancy AnemiaNCT04517734
Erythroferrone and Its Impact on Maternal and Neonatal Iron Homeostasis
An observational study of Pregnancy Anemia and Newborn; Anemia, run by Cornell University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 11 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Anemia, Newborn; Anemia
- How many people
- 338 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2006to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Pregnant women carrying multiple fetuses (twins, triplets and quadruplets) or pregnant adolescents carrying a single fetus
Who may be able to join
- Healthy pregnant volunteers
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Rochester Adolescent Maternity Program
Rochester, New York, 14609
Strong Memorial Hospital
Rochester, New York, 14620
About this study
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.
- Conditions
- Pregnancy Anemia, Newborn; Anemia
- Medical subject headings
- Anemia, Neonatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant Adolescents | Not described | |
| Pregnant Women Carrying Multiple Fetuses | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal Erythroferrone During Pregnancy
Measured: Measures will be obtained from maternal blood collected throughout the 40 weeks of pregnancy
Maternal Erythroferrone at Delivery
Measured: Measures will be obtained from maternal blood collected at delivery
Neonatal Erythroferrone at Birth
Measured: Measures will be obtained from umbilical cord blood collected at delivery
Placental Erythroferrone mRNA and Ferroportin protein Expression
Measured: Measures will be obtained from placental samples collected at delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2020
- Study startApr 2006
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnancy AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 338 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles
- Responsible party
- Sponsor
- Investigators
- Kimberly O'Brien, PhD, Principal investigator, Cornell UniversityElizabeta Nemeth, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04517734
- Sponsor's protocol ID
- 0911001050
- Status last verified
- Mar 2022
- First submitted
- 11 Aug 2020
- Last updated
- 22 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33982118
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erythroferrone and Its Impact on Maternal and Neonatal Iron Homeostasis
- ClinicalTrials.gov ID
- NCT04517734
- Acronym / sponsor ID
- 0911001050
- Conditions
- Pregnancy Anemia, Newborn; Anemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 338 participants (actual)
- Lead sponsor
- Cornell UniversityUniversity, hospital or other
- Collaborators
- University of California, Los Angeles
- Study start
- Apr 2006 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 18 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnant Adolescents | – | – |
| Pregnant Women Carrying Multiple Fetuses | – | – |
Who may qualify
- Ages
- 11 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Pregnant women carrying multiple fetuses (twins, triplets and quadruplets) or pregnant adolescents carrying a single fetus
Key inclusion criteria (1 listed)
- Healthy pregnant volunteers
Key exclusion criteria (7 listed)
- Hemoglobinopathies
- Pre-existing diabetes
- Malabsorption diseases
- Pregnancy induced hypertension
- Elevated diastolic blood pressure (>110)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Maternal Erythroferrone During Pregnancy
Time frame: 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
Neonatal Erythroferrone at Birth
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
- Derived from this study: PubMed 33982118Delaney 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kimberly O'Brien, PhD principal investigator
Cornell University
Elizabeta Nemeth, PhD principal investigator
University of California, Los Angeles
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Anemia and Newborn; Anemia, run by Cornell University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal Erythroferrone During Pregnancy (time frame: Measures will be obtained from maternal blood collected throughout the 40 weeks of pregnancy). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04517734, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2022.