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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer; Mothers; Preschool Children
• Intervention / Treatment: Other: consumption of maize porridge containing stable iron isotope

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 Type: Interventional
• Enrollment (Actual): 275
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kenya
  • Msambweni, Kenya
    • ETH/JKUAT Research Station

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: mothers; healthy volunteers	Other: consumption of maize porridge containing stable iron isotope; consumption of maize porridge containing stable iron isotope
Other: preschool children; healthy volunteers	Other: consumption of maize porridge containing stable iron isotope; consumption of maize porridge containing stable iron isotope

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fractional iron absorption	Erythrocyte iron incorporation	Study day 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum ferritin	Serum ferritin concentration	Study day 1
soluble transferrin receptor	soluble transferrin receptor concentration in serum	Study day 1
C-reactive protein	C-reactive protein concentration in serum	Study day 1
alpha(1)-acid-glycoprotein	alpha(1)-acid-glycoprotein concentration in serum	Study day 1

Collaborators and Investigators

• Sponsor: Isabelle Herter-Aeberli
• Collaborators: Jomo Kenyatta University of Agriculture and Technology

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2024
• Primary Completion (Actual): November 13, 2024
• Study Completion (Actual): November 13, 2024

Study Registration Dates

• First Submitted: October 22, 2024
• First Submitted That Met QC Criteria: October 22, 2024
• First Posted (Actual): October 24, 2024

Study Record Updates

• Last Update Posted (Actual): May 22, 2025
• Last Update Submitted That Met QC Criteria: May 19, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: iron absorption; serum ferritin; maize porridge
• Other Study ID Numbers: MOCHA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No