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Assessment of Iron Absorption and Requirements During Pregnancy and Lactation in Kenyan Women
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.
Age
18 - 45 years
Sex
FEMALE
Healthy Volunteers
No
Msambweni Referral Hospital
Msambweni, Kenya
Start Date
July 31, 2023
Primary Completion Date
June 30, 2026
Completion Date
September 1, 2026
Last Updated
August 3, 2023
250
ESTIMATED participants
CO-rebreathing
OTHER
Oral iron isotope administration (54Fe)
OTHER
Intravenous iron isotope administration (58Fe)
OTHER
Lead Sponsor
University of Oxford
Collaborators
NCT06768060
NCT07462065
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT06273683