Understanding iron needs during pregnancy and lactation
Assessment of Iron Absorption and Requirements During Pregnancy and Lactation in Kenyan Women
This study is trying to find out how much iron pregnant and breastfeeding women in Kenya need and how well their bodies absorb it to help improve their health and nutrition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | University of Oxford Academic / other |
| Locations | 1 site (Msambweni) |
| Trial ID | NCT05973552 on ClinicalTrials.gov |
What this trial studies
This observational study aims to determine the iron requirements and absorption in pregnant and lactating women living in Kenya. By enrolling 250 women in their first trimester who previously participated in an iron absorption study, researchers will utilize stable iron isotope techniques to assess iron levels in the body. The study will follow Kenyan guidelines for prenatal care while focusing on the unique challenges faced by women in Sub-Saharan Africa regarding iron deficiency. The findings could provide critical data to inform dietary recommendations and healthcare practices for this population.
Who should consider this trial
Good fit: Ideal candidates are pregnant women in their first trimester who have previously participated in an iron absorption study and meet specific health criteria.
Not a fit: Patients who are not pregnant, have a high pre-pregnancy BMI, or have major chronic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved dietary guidelines and healthcare strategies for pregnant and lactating women, reducing the risk of anemia.
How similar studies have performed: While studies on iron absorption exist, this specific approach using stable isotopes in pregnant women in Sub-Saharan Africa is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Msambweni
- Msambweni Referral Hospital — Msambweni, Kenya (Recruiting)
Study contacts
- Study coordinator: Nicole Stoffel, PhD
- Email: nicole.stoffel@rdm.ox.ac.uk
- Phone: +41446328393
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.