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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06655909
Enrollment
275
Registered
2024-10-24
Start date
2024-10-23
Completion date
2024-11-13
Last updated
2025-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer, Mothers, Preschool Children

Keywords

iron absorption, serum ferritin, maize porridge

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.

Interventions

OTHERconsumption of maize porridge containing stable iron isotope

consumption of maize porridge containing stable iron isotope

Sponsors

Jomo Kenyatta University of Agriculture and Technology
CollaboratorOTHER
Isabelle Herter-Aeberli
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 30 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Fractional iron absorptionStudy day 14Erythrocyte iron incorporation

Secondary

MeasureTime frameDescription
Serum ferritinStudy day 1Serum ferritin concentration
soluble transferrin receptorStudy day 1soluble transferrin receptor concentration in serum
C-reactive proteinStudy day 1C-reactive protein concentration in serum
alpha(1)-acid-glycoproteinStudy day 1alpha(1)-acid-glycoprotein concentration in serum

Countries

Kenya

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026