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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Cornell University
Sponsor:
Collaborator:
University of Rochester
Information provided by (Responsible Party):
Cornell University
ClinicalTrials.gov Identifier:
NCT01588665
First received: April 26, 2012
Last updated: March 18, 2014
Last verified: March 2014
  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

Resource links provided by NLM:


Further study details as provided by Cornell University:

Primary Outcome Measures:
  • Transfer of iron to the fetus [ Time Frame: The delivery study will be undertaken over a 24 h period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Study Population

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

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01588665

Contacts
Contact: Kimberly O'Brien, PhD 607-255-3743 koo4@cornell.edu
Contact: Sarah Alef 585-410-5381 sarah_alef@urmc.rochester.edu

Locations
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         
Sponsors and Collaborators
Cornell University
University of Rochester
Investigators
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: March 18, 2014
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 September 14, 2014