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

NCT01588665 | Completed

• 1 other identifier: IRB 1203002861
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Iron Deficiency

Keywords

pregnancy; stable isotopes; red blood cell catabolism

Outcome Measures

Primary Outcomes (1)

• Transfer of iron to the fetus

  The delivery study will be undertaken over a 24 h period

Secondary Outcomes (1)

• Maternal and neonatal micronutrient status

  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.

Study Arms (1)

Pregnant women and pregnant adolescents

Eligibility Criteria

• Age: 15 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Cornell University: lead
• University of Rochester: collaborator

Study Sites (1)

Highland Hospital

Rochester, New York, 14642, United States

Location

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

MeSH Terms

Conditions

Iron Deficiencies

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Kimberly O'Brien, PhD

  Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2012
• First Posted: May 1, 2012
• Study Start: April 1, 2012
• Primary Completion: June 1, 2015
• Study Completion: January 20, 2022
• Last Updated: July 12, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)