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

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.

Study Overview

• Status: Completed
• Conditions: Iron-deficiency; Iron Absorption; Ferritin Threshold; Stable Iron Isotopes
• Intervention / Treatment: Other: Isotopically labelled iron sulfate 15mg

• Study Type: Interventional
• Enrollment (Actual): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nicole Stoffel, PhD; Phone Number: +41446328393; Email: nicole.stoffel@hest.ethz.ch

Study Locations

• Kenya
  • Msambweni, Kenya
    • Msambweni County Referral Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 28 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Isotopically labelled iron sulfate 15mg	Other: Isotopically labelled iron sulfate 15mg; test drink: water containing isotopic iron solution with vitamin C

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fractional iron absorption	shift in iron isotopic ratios measured in red blood cells	Day 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma Ferritin		Day 0
soluble transferrin receptor		Day 0
C-reactive protein		Day 0
alpha-1-glycoprotein		Day 0
Hemoglobin		Day 0
Plasma Hepcidin		Day 0
Plasma Ferritin		4 months after isotope administration
Plasma Ferritin		8 months after isotope administration
Plasma Ferritin		12 months after isotope administration
soluble transferrin receptor		4 months after isotope administration
soluble transferrin receptor		8 months after isotope administration
soluble transferrin receptor		12 months after isotope administration
C-reactive protein		4 months after isotope administration
C-reactive protein		8 months after isotope administration
C-reactive protein		12 months after isotope administration
alpha-1-glycoprotein		4 months after isotope administration
alpha-1-glycoprotein		8 months after isotope administration
alpha-1-glycoprotein		12 months after isotope administration
Hemoglobin		4 months after isotope administration
Hemoglobin		8 months after isotope administration
Hemoglobin		12 months after isotope administration
Isotopic composition of red blood cells	shift in iron isotopic ratios measured in red blood cells	4 months after isotope administration
Isotopic composition of red blood cells	shift in iron isotopic ratios measured in red blood cells	8 months after isotope administration
Isotopic composition of red blood cells	shift in iron isotopic ratios measured in red blood cells	12 months after isotope administration

Collaborators and Investigators

• Sponsor: Swiss Federal Institute of Technology
• Collaborators: Jomo Kenyatta University of Agriculture and Technology

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2022
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: February 8, 2022
• First Submitted That Met QC Criteria: March 3, 2022
• First Posted (Actual): March 4, 2022

Study Record Updates

• Last Update Posted (Estimated): January 25, 2024
• Last Update Submitted That Met QC Criteria: January 23, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Iron Metabolism Disorders; Iron Deficiencies
• Other Study ID Numbers: PILLAR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No