Msambweni Referral Hospital
Msambweni, Kenya
Location status: Recruiting
Location contact
Edith Mwasi, MD
CONTACT
NCT Number: NCT05973552
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.
Interested in participating?
Request Info18 year–45 year
Female
Observational
Msambweni, Kenya
Location status: Recruiting
Edith Mwasi, MD
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
In the CO-rebreathing method, a dedicated apparatus is used for inhaling and rebreathing a very small bolus of CO through a spirometer for ~2 min, which is absorbed through the lungs and binds to Hb, and then the increase of HbCO content of blood is measured 8 min after the CO inhalation. The increase of COHb in blood samples can then be used to precisely calculate Hb mass and blood volume
Participants randomly assigned to the sub-group, will receive 54Fe with a test meal in the second and third trimester for assessment of dietary iron absorption
Participants randomly assigned to the sub-group, will receive intravenous 58Fe in the second and third trimester for assessment of erythrocyte iron incorporation
Time frame: Change in 57Fe tracer abundance between gestational age 6, 10 and 15 weeks
isotope dilution
Time frame: Change in 57Fe tracer abundance between gestational age 15, 20 and 25 weeks
isotope dilution
Time frame: Change in 57Fe tracer abundance between gestational age 25, 30 and 35 weeks
isotope dilution
Time frame: Change in 57Fe tracer abundance between gestational age 6, 10, 15, 20, 25, 30 and 35 weeks
isotope dilution
Time frame: Change in 57Fe tracer abundance between 6, 14 and 24 weeks postpartum
isotope dilution
Time frame: Change in 57Fe tracer abundance between age 6, 14 and 24 weeks
isotope dilution
Time frame: gestational age 20 weeks
shift in iron isotopic ratios
Time frame: gestational age 30 weeks
shift in iron isotopic ratios
Time frame: gestational age 20 weeks
shift in iron isotopic ratios
Time frame: gestational age 30 weeks
shift in iron isotopic ratios
Time frame: gestational age 6 weeks
Hb
Time frame: gestational age 10 weeks
Hb
Time frame: gestational age 15 weeks
Hb
Time frame: gestational age 20 weeks
Hb
Time frame: gestational age 25 weeks
Hb
Time frame: gestational age 30 weeks
Hb
Time frame: gestational age 36 weeks
Hb
Time frame: 6 weeks postpartum
mother
Time frame: age 6 weeks
infant
Time frame: 14 weeks postpartum
mother
Time frame: age 14 weeks
infant
Time frame: 24 weeks postpartum
mother
Time frame: age 24 weeks
infant
Time frame: gestational age 6 weeks
MCV
Time frame: gestational age 10 weeks
MCV
Time frame: gestational age 20 weeks
MCV
Time frame: gestational age 30 weeks
MCV
Time frame: 6 weeks postpartum
mother
Time frame: age 6 weeks
infant
Time frame: 14 weeks postpartum
mother
Time frame: age 14 weeks
infant
Time frame: 24 weeks postpartum
mother
Time frame: age 24 weeks
infant
Time frame: gestational age 10 weeks
EPO
Time frame: gestational age 20 weeks
EPO
Time frame: gestational age 30 weeks
EPO
Time frame: 6 weeks postpartum
EPO
Time frame: 14 weeks postpartum
EPO
Time frame: 24 weeks postpartum
EPO
Time frame: gestational age 10 weeks
ERFE
Time frame: gestational age 20 weeks
ERFE
Time frame: gestational age 30 weeks
ERFE
Time frame: 6 weeks postpartum
ERFE
Time frame: 14 weeks postpartum
ERFE
Time frame: 24 weeks postpartum
ERFE
Time frame: gestational age 10 weeks
Hep
Time frame: gestational age 20 weeks
Hep
Time frame: gestational age 30 weeks
Hep
Time frame: 6 weeks postpartum
Hep
Time frame: 14 weeks postpartum
Hep
Time frame: 24 weeks postpartum
Hep
Time frame: gestational age 10 weeks
SF
Time frame: gestational age 20 weeks
SF
Time frame: gestational age 30 weeks
SF
Time frame: 6 weeks postpartum
mother
Time frame: age 6 weeks
infant
Time frame: 14 weeks postpartum
mother
Time frame: age 14 weeks
infant
Time frame: 24 weeks postpartum
mother
Time frame: age 24 weeks
infant
Time frame: gestational age 10 weeks
sTfR
Time frame: gestational age 20 weeks
sTfR
Time frame: gestational age 30 weeks
sTfR
Time frame: 6 weeks postpartum
mother
Time frame: age 6 weeks
infant
Time frame: 14 weeks postpartum
mother
Time frame: age 14 weeks
infant
Time frame: 24 weeks postpartum
mother
Time frame: age 24 weeks
infant
Time frame: gestational age 10 weeks
CRP
Time frame: gestational age 20 weeks
CRP
Time frame: gestational age 30 weeks
CRP
Time frame: 6 weeks postpartum
mother
Time frame: age 6 weeks
infant
Time frame: 14 weeks postpartum
mother
Time frame: age 14 weeks
infant
Time frame: 24 weeks postpartum
mother
Time frame: age 24 weeks
infant
Time frame: gestational age 10 weeks
AGP
Time frame: gestational age 20 weeks
AGP
Time frame: gestational age 30 weeks
AGP
Time frame: 6 weeks postpartum
mother
Time frame: age 6 weeks
infant
Time frame: 14 weeks postpartum
mother
Time frame: age 14 weeks
infant
Time frame: 24 weeks postpartum
mother
Time frame: age 24 weeks
infant
Time frame: gestational age 10 weeks
Time frame: gestational age 20 weeks
BV
Time frame: gestational age 30 weeks
BV
Time frame: 6 weeks postpartum
BV
Time frame: 14 weeks postpartum
BV
Time frame: 24 weeks postpartum
BV
Time frame: gestational age 10 weeks
I-FABP
Time frame: gestational age 20 weeks
I-FABP
Time frame: gestational age 30 weeks
I-FABP
Time frame: gestational age 10 weeks
RBP
Time frame: gestational age 20 weeks
RBP
Time frame: gestational age 30 weeks
RBP
Time frame: gestational age 10 weeks
sCD14
Time frame: gestational age 20 weeks
sCD14
Time frame: gestational age 30 weeks
sCD14
Time frame: gestational age 10 weeks
IGF-1
Time frame: gestational age 20 weeks
IGF-1
Time frame: gestational age 30 weeks
IGF-1
Time frame: gestational age 10 weeks
FGF21
Time frame: gestational age 20 weeks
FGF21
Time frame: gestational age 30 weeks
FGF21
Contact information is provided by the study sponsor or research team.
Joyce Wali, BSc
CONTACT
Nicole Stoffel, PhD
CONTACT
University of Oxford
Other
Assessment of Iron Absorption and Requirements During Pregnancy and Lactation in Kenyan Women
Acronym: PILLAR_II
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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