Actively Recruiting
Assessment of Iron Absorption and Requirements During Pregnancy and Lactation in Kenyan Women
Led by University of Oxford · Updated on 2023-08-03
250
Participants Needed
1
Research Sites
9 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
This research aims to understand iron needs and absorption during pregnancy and lactation in women living in Kenya, where anemia and infections are common. It focuses on pregnant and lactating women, using stable iron isotopes to measure iron absorption, losses, and gains throughout pregnancy and into early infancy. The study enrolls women in their first trimester who previously participated in an iron absorption study. Participants will be followed through pregnancy and the first six months after birth. All women receive standard prenatal care including daily iron and folate supplements as per Kenyan guidelines. A subgroup of women will receive oral and intravenous stable iron isotope tracers in the second and third trimesters to directly assess iron absorption and incorporation into red blood cells. Throughout the study, researchers will collect blood samples from mothers each trimester and at delivery, as well as from infants during the first six months of life. Iron isotope levels, hemoglobin, and other blood markers will be measured to assess iron status and absorption. The study monitors changes in iron isotope abundance at multiple time points during pregnancy and lactation to understand iron requirements and losses in mothers and infants.
CONDITIONS
Brief Title
Iron Absorption and Requirements in Pregnancy and Lactation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Positive pregnancy test with gestational age less than 10 weeks based on last menstrual period
- Permanent residence in the study area with no planned absence longer than 4 weeks over 16 months
- Good health as assessed by professional staff at Msambweni Hospital
You will not qualify if you...
- Pre-pregnancy body mass index over 30 kg/m2
- Blood transfusion or intravenous iron treatment within 4 months before study start
- Major chronic infectious diseases such as tuberculosis, HIV, or hepatitis
- Major chronic non-infectious diseases such as Type 1 or 2 diabetes or cancer
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 10 weeks of gestation
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From less than 10 weeks gestation up to 35 weeks gestation
Participants are followed throughout their pregnancy with repeated measurements of iron status and blood parameters using stable iron isotope tracers and blood samples.
Multiple visits at approximately 6, 10, 15, 20, 25, 30 and 35 weeks gestation
Duration - During the second and third trimester
A randomly selected sub-group of participants receive oral and intravenous stable iron isotope tracers in the second and third trimester to directly assess dietary iron absorption and erythrocyte iron incorporation.
2 visits for tracer administration and assessment 14 days after each administration
Duration - Up to 6 months postpartum
Mother-infant pairs are followed for 6 months postpartum with continued assessment of iron status and blood parameters using stable isotope tracers and blood samples.
Multiple visits at approximately 6, 14 and 24 weeks postpartum
Trial Site Locations
Total: 1 location
1
Msambweni Referral Hospital
Msambweni, Kenya
Actively Recruiting
Research Team
N
Nicole Stoffel, PhD
J
Joyce Wali, BSc
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here