Serum Ferritin Concentration in Kenyan Women and Their Preschool Children at Which the Body Begins to Upregulate Iron Absorption From the Diet

Not Applicable

Completed

• Conditions: Healthy Volunteer; Mothers; Preschool Children

• Registration Number: NCT06655909
• Lead Sponsor: Isabelle Herter-Aeberli

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2024-10-22
• Study First Submitted QC: 2024-10-22
• Study Start: 2024-10-23
• Study First Posted: 2024-10-24
• Primary Completion: 2024-11-13
• Study Completion: 2024-11-13
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 275

Inclusion Criteria

• < 75 kg
• BMI between 17 - 27.5 kg/m2
• No acute illness (self-reported)
• No metabolic or gastrointestinal disorders (self-reported)
• No use of medication affecting iron absorption or metabolism during the study
• No intake of mineral/vitamin supplements 2 weeks prior to the first study visit and during study
• Mother of a preschool age child (2-5 years)
• Child has normal Z-scores for WAZ, HAZ and WHZ (-3 - +3)

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Fractional iron absorption	Study day 14	Erythrocyte iron incorporation

Secondary Outcome Measures

Name	Time	Method
Serum ferritin	Study day 1	Serum ferritin concentration
soluble transferrin receptor	Study day 1	soluble transferrin receptor concentration in serum
C-reactive protein	Study day 1	C-reactive protein concentration in serum
alpha(1)-acid-glycoprotein	Study day 1	alpha(1)-acid-glycoprotein concentration in serum

Trial Locations

Locations (1)

ETH/JKUAT Research Station; 🇰🇪 Msambweni, Kenya