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

F

Federal Institute of Technology (ETH) Zurich

Status

Completed

Conditions

Ferritin Threshold
Iron-deficiency
Stable Iron Isotopes
Iron Absorption

Treatments

Other: Isotopically labelled iron sulfate 15mg

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

1,000 patients

Sex

Female

Ages

18 to 28 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

1,000 participants in 1 patient group

Isotopically labelled iron sulfate 15mg
Other group
Treatment:
Other: Isotopically labelled iron sulfate 15mg

Trial contacts and locations

1

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Central trial contact

Nicole Stoffel, PhD

Data sourced from clinicaltrials.gov

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