Relative Contributions of Red Cell Catabolism and Dietary Absorption to Fetal Iron Accretion During Pregnancy

July 11, 2023 updated by: Cornell University
The two specific aims of this study are 1) to assess the relative contributions of two major maternal iron sources (i.e. dietary iron intake and red cell catabolism) at supplying iron to the fetus, and 2) to determine the impact of maternal and fetal iron status on placental transfer of these two iron sources in pregnant women and adolescents during the last trimester of pregnancy.

Study Overview

Status

Completed

Conditions

Detailed Description

Pregnant women and adolescents (n=24) will be recruited when entering prenatal care. They will be invited to participate in a longitudinal study comparing the relative contribution of the two major maternal iron sources, i.e. maternal dietary iron intake and maternal red blood cell iron recycling, to fetal iron accretion during pregnancy. At about 15 weeks of gestation, participants will consume an oral dose of a stable iron isotope (57Fe as ferrous sulfate) to enrich their red blood cells (RBCs) with 57Fe. Maternal blood samples will be collected at 4 times during pregnancy to monitor changes in blood 57Fe concentrations. In the third trimester of pregnancy, women will consume a dose of a different iron isotope (58Fe as ferrous sulfate) as dietary nonheme iron. Cord blood samples and placental tissue will be obtained at delivery to determine how much of the dietary iron (58Fe) and RBC iron (57Fe) was transferred to the fetus and how much of each isotope was retained in the placenta. Placenta tissue samples will also be used to assess placental expression of iron transporters in relation to the amount of each iron isotopes transferred to the fetus. Circulating iron status indicators and regulators will be measured in all maternal and cord blood samples to examine the effect of iron status on placental transfer of iron derived from the diet vs. RBC during pregnancy.

Study Type

Observational

Enrollment (Actual)

23

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

  • United States
    • New York
      • Rochester, New York, United States, 14642
        • Highland 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

15 years to 35 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Pregnant women and pregnant adolescents from Rochester, NY (n=24)

Description

Inclusion Criteria:

  • Singleton pregnancy
  • Non-smoker
  • No pre-existing medical complications (such as HIV-infection, eating disorders, hemoglobinopathies, malabsorption diseases, steroid use, substance abuse history, or taking medications known to influence iron homeostasis)

Exclusion Criteria:

  • Complicated pregnancy (including gestational diabetes, pregnancy-induced hypertension, or preeclampsia)
  • Individuals been previously treated for lead exposure, or those that have been identified as having elevated blood lead concentrations during childhood, will be excluded from the study

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

Cohorts and Interventions

Group / Cohort
Pregnant women and pregnant adolescents

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Transfer of iron to the fetus
Time Frame: The delivery study will be undertaken over a 24 h period
The delivery study will be undertaken over a 24 h period

Secondary Outcome Measures

Outcome Measure
Time Frame
Maternal and neonatal micronutrient status
Time Frame: Participants will be followed over the course of the pregnancy for an average of 28 weeks. The delivery study will be undertaken over a 24 h period.
Participants will be followed over the course of the pregnancy for an average of 28 weeks. The delivery study will be undertaken over a 24 h period.

Collaborators and Investigators

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

Sponsor

Cornell University

Collaborators

University of Rochester

Investigators

  • Principal Investigator: Kimberly O'Brien, PhD, Cornell University

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

April 1, 2012

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

January 20, 2022

Study Registration Dates

First Submitted

April 26, 2012

First Submitted That Met QC Criteria

April 30, 2012

First Posted (Estimated)

May 1, 2012

Study Record Updates

Last Update Posted (Actual)

July 12, 2023

Last Update Submitted That Met QC Criteria

July 11, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB 1203002861

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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