Clinical trial NCT05973552: Iron Absorption and Requirements in Pregnancy and Lactation
Official title: Assessment of Iron Absorption and Requirements During Pregnancy and Lactation in Kenyan Women
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Iron Requirements
Pregnancy
Lactation
Infancy
Iron Absorption
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: Columbia University
name: Jomo Kenyatta University of Agriculture and Technology
name: Msambweni County Referral Hospital
name: ETH Zurich
First posted: 2023-08-03
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will recruit 250 pregnant women in the first trimester who previously participated in a stable iron isotope study (Clinical Trial ID: NCT05266703) and received 15 mg of the stable iron isotope 57Fe as an oral dose of ferrous sulphate at least 12 months before being enrolled in this trial.

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Iron absorbed, lossed and gained in the first trimester
timeFrame: Change in 57Fe tracer abundance between gestational age 6, 10 and 15 weeks
measure: Iron absorbed, lossed and gained in the second trimester
timeFrame: Change in 57Fe tracer abundance between gestational age 15, 20 and 25 weeks
measure: Iron absorbed, lossed and gained in the third trimester
timeFrame: Change in 57Fe tracer abundance between gestational age 25, 30 and 35 weeks
measure: Iron absorbed, lossed and gained throughout pregnancy
timeFrame: Change in 57Fe tracer abundance between gestational age 6, 10, 15, 20, 25, 30 and 35 weeks
measure: Iron absorbed, lossed and gained in lactating women
timeFrame: Change in 57Fe tracer abundance between 6, 14 and 24 weeks postpartum
measure: Iron absorbed, lossed and gained in infancy
timeFrame: Change in 57Fe tracer abundance between age 6, 14 and 24 weeks
Secondary outcomes:
measure: Fractional iron absorption (%) in the second trimester
timeFrame: gestational age 20 weeks
measure: Fractional iron absorption (%) in the third trimester
timeFrame: gestational age 30 weeks
measure: Erythrocyte iron incorporation (%) in the second trimester
timeFrame: gestational age 20 weeks
measure: Erythrocyte iron incorporation (%) in the third trimester
timeFrame: gestational age 30 weeks
measure: Hemoglobin concentration (g/dl)
timeFrame: gestational age 6 weeks
measure: Hemoglobin concentration (g/dl)
timeFrame: gestational age 10 weeks
measure: Hemoglobin concentration (g/dl)
timeFrame: gestational age 15 weeks
measure: Hemoglobin concentration (g/dl)
timeFrame: gestational age 20 weeks
measure: Hemoglobin concentration (g/dl)
timeFrame: gestational age 25 weeks
measure: Hemoglobin concentration (g/dl)
timeFrame: gestational age 30 weeks
measure: Hemoglobin concentration (g/dl)
timeFrame: gestational age 36 weeks
measure: Hemoglobin concentration (g/dl)
timeFrame: 6 weeks postpartum
measure: Hemoglobin concentration (g/dl)
timeFrame: age 6 weeks
measure: Hemoglobin concentration (g/dl)
timeFrame: 14 weeks postpartum
measure: Hemoglobin concentration (g/dl)
timeFrame: age 14 weeks
measure: Hemoglobin concentration (g/dl)
timeFrame: 24 weeks postpartum
measure: Hemoglobin concentration (g/dl)
timeFrame: age 24 weeks
measure: Mean corpuscular volume (fl)
timeFrame: gestational age 6 weeks
measure: Mean corpuscular volume (fl)
timeFrame: gestational age 10 weeks
measure: Mean corpuscular volume (fl)
timeFrame: gestational age 20 weeks
measure: Mean corpuscular volume (fl)
timeFrame: gestational age 30 weeks
measure: Mean corpuscular volume (fl)
timeFrame: 6 weeks postpartum
measure: Mean corpuscular volume (fl)
timeFrame: age 6 weeks
measure: Mean corpuscular volume (fl)
timeFrame: 14 weeks postpartum
measure: Mean corpuscular volume (fl)
timeFrame: age 14 weeks
measure: Mean corpuscular volume (fl)
timeFrame: 24 weeks postpartum
measure: Mean corpuscular volume (fl)
timeFrame: age 24 weeks
measure: Erythropoietin concentration (mU/ml)
timeFrame: gestational age 10 weeks
measure: Erythropoietin concentration (mU/ml)
timeFrame: gestational age 20 weeks
measure: Erythropoietin concentration (mU/ml)
timeFrame: gestational age 30 weeks
measure: Erythropoietin concentration (mU/ml)
timeFrame: 6 weeks postpartum
measure: Erythropoietin concentration (mU/ml)
timeFrame: 14 weeks postpartum
measure: Erythropoietin concentration (mU/ml)
timeFrame: 24 weeks postpartum
measure: Erythroferrone concentration (ng/ml)
timeFrame: gestational age 10 weeks
measure: Erythroferrone concentration (ng/ml)
timeFrame: gestational age 20 weeks
measure: Erythroferrone concentration (ng/ml)
timeFrame: gestational age 30 weeks
measure: Erythroferrone concentration (ng/ml)
timeFrame: 6 weeks postpartum
measure: Erythroferrone concentration (ng/ml)
timeFrame: 14 weeks postpartum
measure: Erythroferrone concentration (ng/ml)
timeFrame: 24 weeks postpartum
measure: Hepcidin concentration (ng/ml)
timeFrame: gestational age 10 weeks
measure: Hepcidin concentration (ng/ml)
timeFrame: gestational age 20 weeks
measure: Hepcidin concentration (ng/ml)
timeFrame: gestational age 30 weeks
measure: Hepcidin concentration (ng/ml)
timeFrame: 6 weeks postpartum
measure: Hepcidin concentration (ng/ml)
timeFrame: 14 weeks postpartum
measure: Hepcidin concentration (ng/ml)
timeFrame: 24 weeks postpartum
measure: Serum ferritin concentration (ug/l)
timeFrame: gestational age 10 weeks
measure: Serum ferritin concentration (ug/l)
timeFrame: gestational age 20 weeks
measure: Serum ferritin concentration (ug/l)
timeFrame: gestational age 30 weeks
measure: Serum ferritin concentration (ug/l)
timeFrame: 6 weeks postpartum
measure: Serum ferritin concentration (ug/l)
timeFrame: age 6 weeks
measure: Serum ferritin concentration (ug/l)
timeFrame: 14 weeks postpartum
measure: Serum ferritin concentration (ug/l)
timeFrame: age 14 weeks
measure: Serum ferritin concentration (ug/l)
timeFrame: 24 weeks postpartum
measure: Serum ferritin concentration (ug/l)
timeFrame: age 24 weeks
measure: Soluble transferrin receptor concentration (ul/l)
timeFrame: gestational age 10 weeks
measure: Soluble transferrin receptor concentration (ul/l)
timeFrame: gestational age 20 weeks
measure: Soluble transferrin receptor concentration (ul/l)
timeFrame: gestational age 30 weeks
measure: Soluble transferrin receptor concentration (ul/l)
timeFrame: 6 weeks postpartum
measure: Soluble transferrin receptor concentration (ul/l)
timeFrame: age 6 weeks
measure: Soluble transferrin receptor concentration (ul/l)
timeFrame: 14 weeks postpartum
measure: Soluble transferrin receptor concentration (ul/l)
timeFrame: age 14 weeks
measure: Soluble transferrin receptor concentration (ul/l)
timeFrame: 24 weeks postpartum
measure: Soluble transferrin receptor concentration (ul/l)
timeFrame: age 24 weeks
measure: C-reactive protein concentration (mg/l)
timeFrame: gestational age 10 weeks
measure: C-reactive protein concentration (mg/l)
timeFrame: gestational age 20 weeks
measure: C-reactive protein concentration (mg/l)
timeFrame: gestational age 30 weeks
measure: C-reactive protein concentration (mg/l)
timeFrame: 6 weeks postpartum
measure: C-reactive protein concentration (mg/l)
timeFrame: age 6 weeks
measure: C-reactive protein concentration (mg/l)
timeFrame: 14 weeks postpartum
measure: C-reactive protein concentration (mg/l)
timeFrame: age 14 weeks
measure: C-reactive protein concentration (mg/l)
timeFrame: 24 weeks postpartum
measure: C-reactive protein concentration (mg/l)
timeFrame: age 24 weeks
measure: alpha-glycoprotein concentration (mg/dl)
timeFrame: gestational age 10 weeks
measure: alpha-glycoprotein concentration (mg/dl)
timeFrame: gestational age 20 weeks
measure: alpha-glycoprotein concentration (mg/dl)
timeFrame: gestational age 30 weeks
measure: alpha-glycoprotein concentration (mg/dl)
timeFrame: 6 weeks postpartum
measure: alpha-glycoprotein concentration (mg/dl)
timeFrame: age 6 weeks
measure: alpha-glycoprotein concentration (mg/dl)
timeFrame: 14 weeks postpartum
measure: alpha-glycoprotein concentration (mg/dl)
timeFrame: age 14 weeks
measure: alpha-glycoprotein concentration (mg/dl)
timeFrame: 24 weeks postpartum
measure: alpha-glycoprotein concentration (mg/dl)
timeFrame: age 24 weeks
measure: Blood volume (l)
timeFrame: gestational age 10 weeks
measure: Blood volume (l)
timeFrame: gestational age 20 weeks
measure: Blood volume (l)
timeFrame: gestational age 30 weeks
measure: Blood volume (l)
timeFrame: 6 weeks postpartum
measure: Blood volume (l)
timeFrame: 14 weeks postpartum
measure: Blood volume (l)
timeFrame: 24 weeks postpartum
measure: Intestinal fatty acid binding protein
timeFrame: gestational age 10 weeks
measure: Intestinal fatty acid binding protein
timeFrame: gestational age 20 weeks
measure: Intestinal fatty acid binding protein
timeFrame: gestational age 30 weeks
measure: Retinol binding protein
timeFrame: gestational age 10 weeks
measure: Retinol binding protein
timeFrame: gestational age 20 weeks
measure: Retinol binding protein
timeFrame: gestational age 30 weeks
measure: soluble CD14
timeFrame: gestational age 10 weeks
measure: soluble CD14
timeFrame: gestational age 20 weeks
measure: soluble CD14
timeFrame: gestational age 30 weeks
measure: Insulin-like growth factor 1
timeFrame: gestational age 10 weeks
measure: Insulin-like growth factor 1
timeFrame: gestational age 20 weeks
measure: Insulin-like growth factor 1
timeFrame: gestational age 30 weeks
measure: Fibroblast growth factor 21
timeFrame: gestational age 10 weeks
measure: Fibroblast growth factor 21
timeFrame: gestational age 20 weeks
measure: Fibroblast growth factor 21
timeFrame: gestational age 30 weeks
Other outcomes:
Locations:
city: Msambweni
country: Kenya
facility: Msambweni Referral Hospital
Study officials:
References: