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

NCT05266703 | Completed

• 1 other identifier: PILLAR
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Fractional iron absorption

  shift in iron isotopic ratios measured in red blood cells

  Day 14

Secondary Outcomes (24)

• Plasma Ferritin

  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

  Day 0

Study Arms (1)

Isotopically labelled iron sulfate 15mg

OTHER

Other: Isotopically labelled iron sulfate 15mg

Interventions

Isotopically labelled iron sulfate 15mg OTHER

test drink: water containing isotopic iron solution with vitamin C

Isotopically labelled iron sulfate 15mg

Eligibility Criteria

• Age: 18 Years - 28 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• Swiss Federal Institute of Technology: lead
• Jomo Kenyatta University of Agriculture and Technology: collaborator

Study Sites (1)

Msambweni County Referral Hospital

Msambweni, Kenya

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: March 4, 2022
• Study Start: February 18, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: January 25, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1)