Actively Recruiting

Age: 18Years - 45Years
FEMALE
NCT05973552

Iron Absorption and Requirements in Pregnancy and Lactation

Led by University of Oxford · Updated on 2023-08-03

250

Participants Needed

1

Research Sites

161 weeks

Total Duration

On this page

Sponsors

U

University of Oxford

Lead Sponsor

C

Columbia University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Iron Absorption and Requirements in Pregnancy and Lactation

Who Can Participate

Age: 18Years - 45Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Provide consent to the informed consent form
  • Participated in a previous stable isotope absorption study and received an oral dose of 15 mg 57Fe at least 12 months before inclusion
  • Positive pregnancy test with gestational age less than 10 weeks based on last menstrual period
  • Permanent resident in the study area and not expected to leave for more than 4 weeks during the next 16 months
  • Assessed as being in good health by professional staff at Msambweni Hospital
Not Eligible

You will not qualify if you...

  • Pre-pregnancy body mass index greater than 30 kg/m2
  • Received blood transfusion or intravenous iron treatment within 4 months before study start
  • Have major chronic infectious diseases such as tuberculosis, HIV, or hepatitis
  • Have major chronic non-infectious diseases such as Type 1 or 2 diabetes or cancer

AI-Screening

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Trial Site Locations

Total: 1 location

1

Msambweni Referral Hospital

Msambweni, Kenya

Actively Recruiting

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Research Team

N

Nicole Stoffel, PhD

CONTACT

J

Joyce Wali, BSc

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Iron Absorption and Requirements in Pregnancy and Lactation | DecenTrialz