Relative Contributions of Red Cell Catabolism and Dietary Absorption to Fetal Iron Accretion During Pregnancy
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Purpose
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.
| Condition |
|---|
|
Iron Deficiency |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Relative Contributions of Red Cell Catabolism and Dietary Absorption to Fetal Iron Accretion During Pregnancy |
- Transfer of iron to the fetus [ Time Frame: The delivery study will be undertaken over a 24 h period ] [ Designated as safety issue: No ]
- 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. ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
- A total of 45 mL maternal blood sample is collected at five study visits during pregnancy
- At delivery, an additional 10 mL maternal blood sample, a 30 mL cord blood, and the placenta are collected
| Estimated Enrollment: | 24 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | July 2015 |
| Estimated Primary Completion Date: | July 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Pregnant women and pregnant adolescents |
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.
Eligibility| Ages Eligible for Study: | 15 Years to 35 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Pregnant women and pregnant adolescents from Rochester, NY (n=24)
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
Contacts and Locations| Contact: Kimberly O'Brien, PhD | 607-255-3743 | koo4@cornell.edu |
| Contact: Sarah Alef | 585-410-5381 | sarah_alef@urmc.rochester.edu |
| United States, New York | |
| Highland Hospital | Recruiting |
| Rochester, New York, United States, 14642 | |
| Contact: Eva Pressman, PhD 585-275-7480 Eva_Pressman@urmc.rochester.edu | |
| Principal Investigator: Kimberly O'Brien, PhD | |
| Principal Investigator: Eva Pressman, MD | |
| Principal Investigator: Elizabeth Cooper, EdD | |
| Principal Investigator: | Kimberly O'Brien, PhD | Cornell University |
More Information
No publications provided
| Responsible Party: | Cornell University |
| ClinicalTrials.gov Identifier: | NCT01588665 History of Changes |
| Other Study ID Numbers: | IRB 1203002861 |
| Study First Received: | April 26, 2012 |
| Last Updated: | February 12, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Cornell University:
|
pregnancy stable isotopes red blood cell catabolism |
Additional relevant MeSH terms:
|
Anemia, Iron-Deficiency Anemia, Hypochromic Anemia |
Hematologic Diseases Iron Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013