An interventional study of consumption of maize porridge containing stable iron isotope in Healthy Volunteer, Mothers and Preschool Children, sponsored by Isabelle Herter-Aeberli. Completed at 1 site in Kenya. Open to female participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-22.
Sponsored by Isabelle Herter-Aeberli · Not applicable, Interventional, and Other
Using standardized methods, the investigators will perform stable iron isotope absorption studies in young Kenyan women and their preschool children (2-5y of age) with varying iron status to measure iron absorption from maize meal containing labeled ferrous sulfate. Using these data, this study aim is to define the ferritin in these young women and children at which the body senses iron depletion and begins to upregulate iron absorption from the diet; this approach could provide a functionally defined threshold of iron deficiency in Sub-Saharan African women and children.
In this experimental study in southern Kenya, the investigators will take a baseline venous blood sample to measure iron and inflammation biomarkers in generally healthy young women (n=125) and in their preschool children. The investigators will then administer, after an overnight fast, a standardized test meal porridge made from refined maize and bottled water containing the stable iron isotope 57Fe. Fourteen days later, the investigators will take a second venous blood sample for determination of erythrocyte incorporation of the 57Fe to measure iron absorption from the labeled test meal.
Isabelle Herter-Aeberli is the lead sponsor of 13 studies on the registry; 1 is open to participants now.
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Inclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
healthy volunteers
Other: consumption of maize porridge containing stable iron isotope
healthy volunteers
Other: consumption of maize porridge containing stable iron isotope
consumption of maize porridge containing stable iron isotope
Fractional iron absorption
Erythrocyte iron incorporation
Time frame: Study day 14
Serum ferritin
Serum ferritin concentration
Time frame: Study day 1
soluble transferrin receptor
soluble transferrin receptor concentration in serum
Time frame: Study day 1
C-reactive protein
C-reactive protein concentration in serum
Time frame: Study day 1
alpha(1)-acid-glycoprotein
alpha(1)-acid-glycoprotein concentration in serum
Time frame: Study day 1
Plan to share: No
No publications or documents are linked to this record.
Ran from Oct 2024 to primary completion in Nov 2024, 0 months.
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This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Isabelle Herter-Aeberli