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

• Sponsor: Swiss Federal Institute of Technology (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05266703
• Collaborator: Jomo Kenyatta University of Agriculture and Technology (Other)
• Enrollment: 1,000
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 5.4
• Patients Per Site Per Month: 185.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Iron-deficiency; Ferritin Threshold; Iron Absorption; Stable Iron Isotopes	Other: Isotopically labelled iron sulfate 15mg	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 1000 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Defining the Serum Ferritin Concentration in Kenyan Women at Which the Body Senses Iron Depletion and Begins to Upregulate Iron Absorption
• Actual Study Start Date: Feb 18, 2022
• Anticipated Primary Completion Date: Aug 1, 2022
• Anticipated Study Completion Date: Aug 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Fractional iron absorption [Day 14]

   shift in iron isotopic ratios measured in red blood cells

Secondary Outcome Measures

1. Plasma Ferritin [Day 0]

2. soluble transferrin receptor [Day 0]

3. C-reactive protein [Day 0]

4. alpha-1-glycoprotein [Day 0]

5. Hemoglobin [Day 0]

6. Plasma Hepcidin [Day 0]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 28 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Msambweni County Referral Hospital	Msambweni		Kenya

Sponsors and Collaborators

• Swiss Federal Institute of Technology
• Jomo Kenyatta University of Agriculture and Technology

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Swiss Federal Institute of Technology
• ClinicalTrials.gov Identifier: NCT05266703
• Other Study ID Numbers: PILLAR
• First Posted: Mar 4, 2022
• Last Update Posted: Mar 4, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Anemia, Iron-Deficiency

Study Results

No Results Posted as of Mar 4, 2022