Actively Recruiting
Iron Absorption and Requirements in Pregnancy and Lactation
Led by University of Oxford · Updated on 2023-08-03
250
Participants Needed
1
Research Sites
161 weeks
Total Duration
On this page
Sponsors
U
University of Oxford
Lead Sponsor
C
Columbia University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 non-PLW. High-quality quantitative data on iron requirements in PLW are lacking, particularly in Sub- Saharan Africa where anaemia and infections are common. The primary objective of this study is to use the stable iron isotope technique to determine iron requirements and assess iron absorption and losses in PLW living in Kenya. In this prospective observational study, we will enrol pregnant women in the first trimester (n = 250) from a previous study cohort (n=1000) who participated in an iron absorption study at least 12 months ago and received the stable iron (Fe) isotope 57Fe. This 57Fe has now distributed and equilibrated throughout the women's body iron. Once enrolled in the present study, following Kenyan guidelines, women will receive standard prenatal care, including routine daily iron and folate supplementation. We will collect venous blood samples in each trimester and at delivery, and during the first 6 months of lactation in the mothers and infants (heel prick samples). To directly assess dietary iron absorption, in a randomly selected subset of women (n=35), oral and intravenous stable iron isotope tracers (54Fe, 58Fe) will be administered in the 2nd and 3rd trimesters.
CONDITIONS
Official Title
Iron Absorption and Requirements in Pregnancy and Lactation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide consent to the informed consent form
- Participated in a previous stable isotope absorption study and received an oral dose of 15 mg 57Fe at least 12 months before inclusion
- Positive pregnancy test with gestational age less than 10 weeks based on last menstrual period
- Permanent resident in the study area and not expected to leave for more than 4 weeks during the next 16 months
- Assessed as being in good health by professional staff at Msambweni Hospital
You will not qualify if you...
- Pre-pregnancy body mass index greater than 30 kg/m2
- Received blood transfusion or intravenous iron treatment within 4 months before study start
- Have major chronic infectious diseases such as tuberculosis, HIV, or hepatitis
- Have major chronic non-infectious diseases such as Type 1 or 2 diabetes or cancer
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Msambweni Referral Hospital
Msambweni, Kenya
Actively Recruiting
Research Team
N
Nicole Stoffel, PhD
CONTACT
J
Joyce Wali, BSc
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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