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

NCT ID: NCT06655909

Last Updated: 2025-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 275 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-23
• Study Completion Date: 2024-11-13

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.

Conditions

Healthy Volunteer; Mothers; Preschool Children

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

mothers

healthy volunteers

Group Type: OTHER

consumption of maize porridge containing stable iron isotope

Intervention Type: OTHER

consumption of maize porridge containing stable iron isotope

preschool children

healthy volunteers

Group Type: OTHER

consumption of maize porridge containing stable iron isotope

Intervention Type: OTHER

consumption of maize porridge containing stable iron isotope

Interventions

consumption of maize porridge containing stable iron isotope

consumption of maize porridge containing stable iron isotope

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Jomo Kenyatta University of Agriculture and Technology

OTHER

Sponsor Role: collaborator

Isabelle Herter-Aeberli

OTHER

Sponsor Role: lead

Responsible Party

Isabelle Herter-Aeberli

PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

ETH/JKUAT Research Station

Msambweni, , Kenya

Countries

Kenya

Other Identifiers

MOCHA

Identifier Type: -

Identifier Source: org_study_id