Iron Absorption and Requirements in Pregnancy and Lactation

Pregnancy Clinical Trial

— PILLAR_II  

Official title:

Assessment of Iron Absorption and Requirements During Pregnancy and Lactation in Kenyan Women

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05973552
• Other study ID #: PILLAR_II
• Status: Recruiting
• Start date: July 31, 2023
• Est. completion date: September 1, 2026

Study information

• Verified date: June 2023
• Source: University of Oxford
• Contact: Nicole Stoffel, PhD
• Phone: +41446328393
• Email: nicole.stoffel[@]rdm.ox.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: September 1, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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)

Related Conditions & MeSH terms

• Iron Absorption
• Lactation
• Pregnancy

Intervention

Other:
• CO-rebreathing
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
• Oral iron isotope administration (54Fe)
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
• Intravenous iron isotope administration (58Fe)
Participants randomly assigned to the sub-group, will receive intravenous 58Fe in the second and third trimester for assessment of erythrocyte iron incorporation

Locations

Country	Name	City	State
Kenya	Msambweni Referral Hospital	Msambweni

Sponsors (5)

Lead Sponsor	Collaborator
University of Oxford	Columbia University, ETH Zurich, Jomo Kenyatta University of Agriculture and Technology, Msambweni County Referral Hospital

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Iron absorbed, lossed and gained in the first trimester	isotope dilution	Change in 57Fe tracer abundance between gestational age 6, 10 and 15 weeks
Primary	Iron absorbed, lossed and gained in the second trimester	isotope dilution	Change in 57Fe tracer abundance between gestational age 15, 20 and 25 weeks
Primary	Iron absorbed, lossed and gained in the third trimester	isotope dilution	Change in 57Fe tracer abundance between gestational age 25, 30 and 35 weeks
Primary	Iron absorbed, lossed and gained throughout pregnancy	isotope dilution	Change in 57Fe tracer abundance between gestational age 6, 10, 15, 20, 25, 30 and 35 weeks
Primary	Iron absorbed, lossed and gained in lactating women	isotope dilution	Change in 57Fe tracer abundance between 6, 14 and 24 weeks postpartum
Primary	Iron absorbed, lossed and gained in infancy	isotope dilution	Change in 57Fe tracer abundance between age 6, 14 and 24 weeks
Secondary	Fractional iron absorption (%) in the second trimester	shift in iron isotopic ratios	gestational age 20 weeks
Secondary	Fractional iron absorption (%) in the third trimester	shift in iron isotopic ratios	gestational age 30 weeks
Secondary	Erythrocyte iron incorporation (%) in the second trimester	shift in iron isotopic ratios	gestational age 20 weeks
Secondary	Erythrocyte iron incorporation (%) in the third trimester	shift in iron isotopic ratios	gestational age 30 weeks
Secondary	Hemoglobin concentration (g/dl)	Hb	gestational age 6 weeks
Secondary	Hemoglobin concentration (g/dl)	Hb	gestational age 10 weeks
Secondary	Hemoglobin concentration (g/dl)	Hb	gestational age 15 weeks
Secondary	Hemoglobin concentration (g/dl)	Hb	gestational age 20 weeks
Secondary	Hemoglobin concentration (g/dl)	Hb	gestational age 25 weeks
Secondary	Hemoglobin concentration (g/dl)	Hb	gestational age 30 weeks
Secondary	Hemoglobin concentration (g/dl)	Hb	gestational age 36 weeks
Secondary	Hemoglobin concentration (g/dl)	mother	6 weeks postpartum
Secondary	Hemoglobin concentration (g/dl)	infant	age 6 weeks
Secondary	Hemoglobin concentration (g/dl)	mother	14 weeks postpartum
Secondary	Hemoglobin concentration (g/dl)	infant	age 14 weeks
Secondary	Hemoglobin concentration (g/dl)	mother	24 weeks postpartum
Secondary	Hemoglobin concentration (g/dl)	infant	age 24 weeks
Secondary	Mean corpuscular volume (fl)	MCV	gestational age 6 weeks
Secondary	Mean corpuscular volume (fl)	MCV	gestational age 10 weeks
Secondary	Mean corpuscular volume (fl)	MCV	gestational age 20 weeks
Secondary	Mean corpuscular volume (fl)	MCV	gestational age 30 weeks
Secondary	Mean corpuscular volume (fl)	mother	6 weeks postpartum
Secondary	Mean corpuscular volume (fl)	infant	age 6 weeks
Secondary	Mean corpuscular volume (fl)	mother	14 weeks postpartum
Secondary	Mean corpuscular volume (fl)	infant	age 14 weeks
Secondary	Mean corpuscular volume (fl)	mother	24 weeks postpartum
Secondary	Mean corpuscular volume (fl)	infant	age 24 weeks
Secondary	Erythropoietin concentration (mU/ml)	EPO	gestational age 10 weeks
Secondary	Erythropoietin concentration (mU/ml)	EPO	gestational age 20 weeks
Secondary	Erythropoietin concentration (mU/ml)	EPO	gestational age 30 weeks
Secondary	Erythropoietin concentration (mU/ml)	EPO	6 weeks postpartum
Secondary	Erythropoietin concentration (mU/ml)	EPO	14 weeks postpartum
Secondary	Erythropoietin concentration (mU/ml)	EPO	24 weeks postpartum
Secondary	Erythroferrone concentration (ng/ml)	ERFE	gestational age 10 weeks
Secondary	Erythroferrone concentration (ng/ml)	ERFE	gestational age 20 weeks
Secondary	Erythroferrone concentration (ng/ml)	ERFE	gestational age 30 weeks
Secondary	Erythroferrone concentration (ng/ml)	ERFE	6 weeks postpartum
Secondary	Erythroferrone concentration (ng/ml)	ERFE	14 weeks postpartum
Secondary	Erythroferrone concentration (ng/ml)	ERFE	24 weeks postpartum
Secondary	Hepcidin concentration (ng/ml)	Hep	gestational age 10 weeks
Secondary	Hepcidin concentration (ng/ml)	Hep	gestational age 20 weeks
Secondary	Hepcidin concentration (ng/ml)	Hep	gestational age 30 weeks
Secondary	Hepcidin concentration (ng/ml)	Hep	6 weeks postpartum
Secondary	Hepcidin concentration (ng/ml)	Hep	14 weeks postpartum
Secondary	Hepcidin concentration (ng/ml)	Hep	24 weeks postpartum
Secondary	Serum ferritin concentration (ug/l)	SF	gestational age 10 weeks
Secondary	Serum ferritin concentration (ug/l)	SF	gestational age 20 weeks
Secondary	Serum ferritin concentration (ug/l)	SF	gestational age 30 weeks
Secondary	Serum ferritin concentration (ug/l)	mother	6 weeks postpartum
Secondary	Serum ferritin concentration (ug/l)	infant	age 6 weeks
Secondary	Serum ferritin concentration (ug/l)	mother	14 weeks postpartum
Secondary	Serum ferritin concentration (ug/l)	infant	age 14 weeks
Secondary	Serum ferritin concentration (ug/l)	mother	24 weeks postpartum
Secondary	Serum ferritin concentration (ug/l)	infant	age 24 weeks
Secondary	Soluble transferrin receptor concentration (ul/l)	sTfR	gestational age 10 weeks
Secondary	Soluble transferrin receptor concentration (ul/l)	sTfR	gestational age 20 weeks
Secondary	Soluble transferrin receptor concentration (ul/l)	sTfR	gestational age 30 weeks
Secondary	Soluble transferrin receptor concentration (ul/l)	mother	6 weeks postpartum
Secondary	Soluble transferrin receptor concentration (ul/l)	infant	age 6 weeks
Secondary	Soluble transferrin receptor concentration (ul/l)	mother	14 weeks postpartum
Secondary	Soluble transferrin receptor concentration (ul/l)	infant	age 14 weeks
Secondary	Soluble transferrin receptor concentration (ul/l)	mother	24 weeks postpartum
Secondary	Soluble transferrin receptor concentration (ul/l)	infant	age 24 weeks
Secondary	C-reactive protein concentration (mg/l)	CRP	gestational age 10 weeks
Secondary	C-reactive protein concentration (mg/l)	CRP	gestational age 20 weeks
Secondary	C-reactive protein concentration (mg/l)	CRP	gestational age 30 weeks
Secondary	C-reactive protein concentration (mg/l)	mother	6 weeks postpartum
Secondary	C-reactive protein concentration (mg/l)	infant	age 6 weeks
Secondary	C-reactive protein concentration (mg/l)	mother	14 weeks postpartum
Secondary	C-reactive protein concentration (mg/l)	infant	age 14 weeks
Secondary	C-reactive protein concentration (mg/l)	mother	24 weeks postpartum
Secondary	C-reactive protein concentration (mg/l)	infant	age 24 weeks
Secondary	alpha-glycoprotein concentration (mg/dl)	AGP	gestational age 10 weeks
Secondary	alpha-glycoprotein concentration (mg/dl)	AGP	gestational age 20 weeks
Secondary	alpha-glycoprotein concentration (mg/dl)	AGP	gestational age 30 weeks
Secondary	alpha-glycoprotein concentration (mg/dl)	mother	6 weeks postpartum
Secondary	alpha-glycoprotein concentration (mg/dl)	infant	age 6 weeks
Secondary	alpha-glycoprotein concentration (mg/dl)	mother	14 weeks postpartum
Secondary	alpha-glycoprotein concentration (mg/dl)	infant	age 14 weeks
Secondary	alpha-glycoprotein concentration (mg/dl)	mother	24 weeks postpartum
Secondary	alpha-glycoprotein concentration (mg/dl)	infant	age 24 weeks
Secondary	Blood volume (l)		gestational age 10 weeks
Secondary	Blood volume (l)	BV	gestational age 20 weeks
Secondary	Blood volume (l)	BV	gestational age 30 weeks
Secondary	Blood volume (l)	BV	6 weeks postpartum
Secondary	Blood volume (l)	BV	14 weeks postpartum
Secondary	Blood volume (l)	BV	24 weeks postpartum
Secondary	Intestinal fatty acid binding protein	I-FABP	gestational age 10 weeks
Secondary	Intestinal fatty acid binding protein	I-FABP	gestational age 20 weeks
Secondary	Intestinal fatty acid binding protein	I-FABP	gestational age 30 weeks
Secondary	Retinol binding protein	RBP	gestational age 10 weeks
Secondary	Retinol binding protein	RBP	gestational age 20 weeks
Secondary	Retinol binding protein	RBP	gestational age 30 weeks
Secondary	soluble CD14	sCD14	gestational age 10 weeks
Secondary	soluble CD14	sCD14	gestational age 20 weeks
Secondary	soluble CD14	sCD14	gestational age 30 weeks
Secondary	Insulin-like growth factor 1	IGF-1	gestational age 10 weeks
Secondary	Insulin-like growth factor 1	IGF-1	gestational age 20 weeks
Secondary	Insulin-like growth factor 1	IGF-1	gestational age 30 weeks
Secondary	Fibroblast growth factor 21	FGF21	gestational age 10 weeks
Secondary	Fibroblast growth factor 21	FGF21	gestational age 20 weeks
Secondary	Fibroblast growth factor 21	FGF21	gestational age 30 weeks