- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01588665
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
-
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New York
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Rochester, New York, United States, 14642
- Highland Hospital
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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 |
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Pregnant women and pregnant adolescents
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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
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The delivery study will be undertaken over a 24 h period
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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
Collaborators
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
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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