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Defining the Serum Ferritin Concentration in Kenyan Women at Which the Body Senses Iron Depletion and Begins to Upregulate Iron Absorption

Defining the Serum Ferritin Concentration in Kenyan Women at Which the Body Senses Iron Depletion and Begins to Upregulate Iron Absorption

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05266703
Enrollment
1000
Registered
2022-03-04
Start date
2022-02-18
Completion date
2023-06-30
Last updated
2024-01-25

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

Conditions

Ferritin Threshold, Iron Absorption, Iron-deficiency, Stable Iron Isotopes

Brief summary

The serum or plasma ferritin concentration (referred to hereafter as ferritin) is the most widely used indicator to detect iron deficiency and a low ferritin indicates depleted iron stores. However, the threshold ferritin that defines iron deficiency remains unclear and diagnostic ferritin cutoffs from expert groups vary widely. Our study aim is to define the ferritin in Kenyan young women 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.

Interventions

OTHERIsotopically labelled iron sulfate 15mg

test drink: water containing isotopic iron solution with vitamin C

Sponsors

Jomo Kenyatta University of Agriculture and Technology
CollaboratorOTHER
Swiss Federal Institute of Technology
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 28 Years
Healthy volunteers
Yes

Inclusion criteria

* Age 18-28 y, not pregnant or lactating * Body weight \<75 kg * body mass index (BMI) between 17 and 25 kg/m2 * No acute illness/infection (self-reported) * No metabolic or gastrointestinal disorders (self-reported) * No use of medications affecting iron absorption or metabolism during the study * No intake of mineral/vitamin supplements 2 weeks prior to the first study visit and during the study

Design outcomes

Primary

MeasureTime frameDescription
Fractional iron absorptionDay 14shift in iron isotopic ratios measured in red blood cells

Secondary

MeasureTime frameDescription
HemoglobinDay 0
Plasma HepcidinDay 0
Isotopic composition of red blood cells4 months after isotope administrationshift in iron isotopic ratios measured in red blood cells
alpha-1-glycoproteinDay 0
soluble transferrin receptorDay 0
C-reactive proteinDay 0
Plasma FerritinDay 0

Countries

Kenya

Outcome results

None listed

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