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

Iron-deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05266703
• Other study ID #: PILLAR
• Status: Completed
• Phase: N/A
• Start date: February 18, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: January 2024
• Source: Swiss Federal Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 28 Years

Eligibility

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

Related Conditions & MeSH terms

• Iron Absorption
• Iron-deficiency

Intervention

Other:
• Isotopically labelled iron sulfate 15mg
test drink: water containing isotopic iron solution with vitamin C

Locations

Country	Name	City	State
Kenya	Msambweni County Referral Hospital	Msambweni

Sponsors (2)

Lead Sponsor	Collaborator
Swiss Federal Institute of Technology	Jomo Kenyatta University of Agriculture and Technology

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fractional iron absorption	shift in iron isotopic ratios measured in red blood cells	Day 14
Secondary	Plasma Ferritin		Day 0
Secondary	Plasma Ferritin		4 months after isotope administration
Secondary	Plasma Ferritin		8 months after isotope administration
Secondary	Plasma Ferritin		12 months after isotope administration
Secondary	soluble transferrin receptor		Day 0
Secondary	soluble transferrin receptor		4 months after isotope administration
Secondary	soluble transferrin receptor		8 months after isotope administration
Secondary	soluble transferrin receptor		12 months after isotope administration
Secondary	C-reactive protein		Day 0
Secondary	C-reactive protein		4 months after isotope administration
Secondary	C-reactive protein		8 months after isotope administration
Secondary	C-reactive protein		12 months after isotope administration
Secondary	alpha-1-glycoprotein		Day 0
Secondary	alpha-1-glycoprotein		4 months after isotope administration
Secondary	alpha-1-glycoprotein		8 months after isotope administration
Secondary	alpha-1-glycoprotein		12 months after isotope administration
Secondary	Hemoglobin		Day 0
Secondary	Hemoglobin		4 months after isotope administration
Secondary	Hemoglobin		8 months after isotope administration
Secondary	Hemoglobin		12 months after isotope administration
Secondary	Plasma Hepcidin		Day 0
Secondary	Isotopic composition of red blood cells	shift in iron isotopic ratios measured in red blood cells	4 months after isotope administration
Secondary	Isotopic composition of red blood cells	shift in iron isotopic ratios measured in red blood cells	8 months after isotope administration
Secondary	Isotopic composition of red blood cells	shift in iron isotopic ratios measured in red blood cells	12 months after isotope administration