About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- CO-rebreathing
- Oral iron isotope administration (54Fe)
- Intravenous iron isotope administration (58Fe)
Treatment groups
Sponsors and collaborators
University of Oxford
Lead sponsor
Columbia University
Collaborator
Jomo Kenyatta University of Agriculture and Technology
Collaborator
Msambweni County Referral Hospital
Collaborator
ETH Zurich
Collaborator