Iron Absorption and Requirements in Pregnancy and Lactation
NCT ID: NCT05973552
Last Updated: 2023-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
250 participants
OBSERVATIONAL
2023-07-31
2026-09-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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All participants
Women (n=250), are followed throughout their pregnancy. Mother-infant pairs are followed throughout the first 6-months postpartum. Women receive daily oral iron supplementation during pregnancy in accordance with local standards of care. Using the stable iron isotopes dilution methodology, concentration of the stable iron isotope tracer (57Fe) in circulation will be measured throughout pregnancy and up to 6 months postpartum in both, mother and infant.
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
Randomly selected sub-group
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. Oral iron absorption and erythrocyte iron incorporation will be measured 14 days after tracer administration.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
45 Years
FEMALE
No
Sponsors
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Columbia University
OTHER
Jomo Kenyatta University of Agriculture and Technology
OTHER
Msambweni County Referral Hospital
UNKNOWN
ETH Zurich
OTHER
University of Oxford
OTHER
Responsible Party
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Locations
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Msambweni Referral Hospital
Msambweni, , Kenya
Countries
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Central Contacts
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Facility Contacts
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Edith Mwasi, MD
Role: primary
Other Identifiers
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PILLAR_II
Identifier Type: -
Identifier Source: org_study_id
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