Status:
RECRUITING
Iron Absorption and Requirements in Pregnancy and Lactation
Lead Sponsor:
University of Oxford
Collaborating Sponsors:
Columbia University
Jomo Kenyatta University of Agriculture and Technology
Conditions:
Iron Requirements
Pregnancy
Eligibility:
FEMALE
18-45 years
Brief Summary
Iron requirements increase significantly during pregnancy. Current recommendations for iron intake in pregnant and lactating women (PLW) are mainly based on factorial estimates and extrapolated from n...
Eligibility Criteria
Inclusion
- Providing consent to the informed consent form
- Participation in a previous stable isotope absorption study and having received an oral dose of 15 mg 57Fe at least 12 months prior to the date of inclusion in the study
- Positive pregnancy test and gestational age \<10 weeks based on history of last menstrual period
- Permanent residence in the study area, and not expected to leave the study site for more than 4 weeks over the following 16 months
- Assessment of good health by professional staff at Msambweni Hospital
Exclusion
- Pre-pregnancy body mass index \>30 kg/m2
- Blood transfusion or intravenous iron treatment within 4 months of study start
- Major chronic infectious disease (e.g., tuberculosis, HIV+, hepatitis)
- Major chronic non-infectious disease (e.g., Type 1 or 2 diabetes, cancer)
Key Trial Info
Start Date :
July 31 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT05973552
Start Date
July 31 2023
End Date
September 1 2026
Last Update
August 3 2023
Active Locations (1)
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1
Msambweni Referral Hospital
Msambweni, Kenya