Clinical trial NCT05266703: Defining the Serum Ferritin Concentration in Kenyan Women at Which the Body Senses Iron Depletion and Begins to Upregulate Iron Absorption
Official title: Defining the Serum Ferritin Concentration in Kenyan Women at Which the Body Senses Iron Depletion and Begins to Upregulate Iron Absorption
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron-deficiency
Ferritin Threshold
Iron Absorption
Stable Iron Isotopes
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
Collaborators: name: Jomo Kenyatta University of Agriculture and Technology
First posted: 2022-03-04
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Fractional iron absorption
timeFrame: Day 14
Secondary outcomes:
measure: Plasma Ferritin
timeFrame: Day 0
measure: Plasma Ferritin
timeFrame: 4 months after isotope administration
measure: Plasma Ferritin
timeFrame: 8 months after isotope administration
measure: Plasma Ferritin
timeFrame: 12 months after isotope administration
measure: soluble transferrin receptor
timeFrame: Day 0
measure: soluble transferrin receptor
timeFrame: 4 months after isotope administration
measure: soluble transferrin receptor
timeFrame: 8 months after isotope administration
measure: soluble transferrin receptor
timeFrame: 12 months after isotope administration
measure: C-reactive protein
timeFrame: Day 0
measure: C-reactive protein
timeFrame: 4 months after isotope administration
measure: C-reactive protein
timeFrame: 8 months after isotope administration
measure: C-reactive protein
timeFrame: 12 months after isotope administration
measure: alpha-1-glycoprotein
timeFrame: Day 0
measure: alpha-1-glycoprotein
timeFrame: 4 months after isotope administration
measure: alpha-1-glycoprotein
timeFrame: 8 months after isotope administration
measure: alpha-1-glycoprotein
timeFrame: 12 months after isotope administration
measure: Hemoglobin
timeFrame: Day 0
measure: Hemoglobin
timeFrame: 4 months after isotope administration
measure: Hemoglobin
timeFrame: 8 months after isotope administration
measure: Hemoglobin
timeFrame: 12 months after isotope administration
measure: Plasma Hepcidin
timeFrame: Day 0
measure: Isotopic composition of red blood cells
timeFrame: 4 months after isotope administration
measure: Isotopic composition of red blood cells
timeFrame: 8 months after isotope administration
measure: Isotopic composition of red blood cells
timeFrame: 12 months after isotope administration
Other outcomes:
Locations:
city: Msambweni
country: Kenya
facility: Msambweni County Referral Hospital
Study officials:
References: