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

NCT06655909 | Completed

• 1 other identifier: MOCHA
• Study Type: interventional
• Target: 275
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteer; Mothers; Preschool Children

Keywords

iron absorption; serum ferritin; maize porridge

Outcome Measures

Primary Outcomes (1)

• Fractional iron absorption

  Erythrocyte iron incorporation

  Study day 14

Secondary Outcomes (4)

• Serum ferritin

  Study day 1

• soluble transferrin receptor

  Study day 1

• C-reactive protein

  Study day 1

• alpha(1)-acid-glycoprotein

  Study day 1

Study Arms (2)

mothers

OTHER

healthy volunteers

Other: consumption of maize porridge containing stable iron isotope

preschool children

OTHER

healthy volunteers

Other: consumption of maize porridge containing stable iron isotope

Interventions

consumption of maize porridge containing stable iron isotope OTHER

consumption of maize porridge containing stable iron isotope

mothers; preschool children

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \< 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)

Sponsors & Collaborators

• Isabelle Herter-Aeberli: lead
• Jomo Kenyatta University of Agriculture and Technology: collaborator

Study Sites (1)

ETH/JKUAT Research Station

Msambweni, Kenya

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: October 24, 2024
• Study Start: October 23, 2024
• Primary Completion: November 13, 2024
• Study Completion: November 13, 2024
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1)