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

Not Applicable

Completed

• Conditions: Iron-deficiency; Ferritin Threshold; Stable Iron Isotopes; Iron Absorption
• Interventions: Other: Isotopically labelled iron sulfate 15mg

• Registration Number: NCT05266703
• Lead Sponsor: Swiss Federal Institute of Technology

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-08
• Study Start: 2022-02-18
• Study First Submitted QC: 2022-03-03
• Study First Posted: 2022-03-04
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-23
• Last Update Posted: 2024-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1000

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Isotopically labelled iron sulfate 15mg	Isotopically labelled iron sulfate 15mg	-

Primary Outcome Measures

Name	Time	Method
Fractional iron absorption	Day 14	shift in iron isotopic ratios measured in red blood cells

Secondary Outcome Measures

Name	Time	Method
alpha-1-glycoprotein	12 months after isotope administration
C-reactive protein	12 months after isotope administration
Plasma Ferritin	12 months after isotope administration
soluble transferrin receptor	12 months after isotope administration
Hemoglobin	12 months after isotope administration
Plasma Hepcidin	Day 0
Isotopic composition of red blood cells	12 months after isotope administration	shift in iron isotopic ratios measured in red blood cells

Trial Locations

Locations (1)

Msambweni County Referral Hospital; 🇰🇪 Msambweni, Kenya