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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01588665
Recruitment Status : Active, not recruiting
First Posted : May 1, 2012
Last Update Posted : February 1, 2018
University of Rochester
Information provided by (Responsible Party):
Cornell University

Brief Summary:
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 or disease
Iron Deficiency

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
Actual Enrollment : 23 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Relative Contributions of Red Cell Catabolism and Dietary Absorption to Fetal Iron Accretion During Pregnancy
Study Start Date : April 2012
Actual Primary Completion Date : June 2015
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron
U.S. FDA Resources

Pregnant women and pregnant adolescents

Primary Outcome Measures :
  1. Transfer of iron to the fetus [ Time Frame: The delivery study will be undertaken over a 24 h period ]

Secondary Outcome Measures :
  1. 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. ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 35 Years   (Child, Adult)
Sexes 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)

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01588665

United States, New York
Highland Hospital
Rochester, New York, United States, 14642
Sponsors and Collaborators
Cornell University
University of Rochester
Principal Investigator: Kimberly O'Brien, PhD Cornell University

Responsible Party: Cornell University Identifier: NCT01588665     History of Changes
Other Study ID Numbers: IRB 1203002861
First Posted: May 1, 2012    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Cornell University:
stable isotopes
red blood cell catabolism

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Anemia, Hypochromic
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases