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Completed

NCT Number: NCT06655909

Serum Ferritin Concentration in Kenyan Women and Their Preschool Children at Which the Body Begins to Upregulate Iron Absorption From the Diet

Using standardized methods, the investigators will perform stable iron isotope absorption studies in young Kenyan women and their preschool children (2-5y of age) with varying iron status to measure iron absorption from maize meal containing labeled ferrous sulfate. Using these data, this study aim is to define the ferritin in these young women and children 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 and children.

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Key information

Conditions

Healthy Volunteer Mothers Preschool Children

Age range

18 year–30 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

ETH/JKUAT Research Station

Msambweni, Kenya

About this study

In this experimental study in southern Kenya, the investigators will take a baseline venous blood sample to measure iron and inflammation biomarkers in generally healthy young women (n=125) and in their preschool children. The investigators will then administer, after an overnight fast, a standardized test meal porridge made from refined maize and bottled water containing the stable iron isotope 57Fe. Fourteen days later, the investigators will take a second venous blood sample for determination of erythrocyte incorporation of the 57Fe to measure iron absorption from the labeled test meal.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • < 75 kg
  • BMI between 17 - 27.5 kg/m2
  • No acute illness (self-reported)
  • No metabolic or gastrointestinal disorders (self-reported)
  • No use of medication affecting iron absorption or metabolism during the study
  • No intake of mineral/vitamin supplements 2 weeks prior to the first study visit and during study
  • Mother of a preschool age child (2-5 years)
  • Child has normal Z-scores for WAZ, HAZ and WHZ (-3 - +3)

Treatment and study plan

consumption of maize porridge containing stable iron isotope

Other

consumption of maize porridge containing stable iron isotope

Primary outcomes

  1. Fractional iron absorption

    Time frame: Study day 14

    Erythrocyte iron incorporation

Secondary outcomes

  1. Serum ferritin

    Time frame: Study day 1

    Serum ferritin concentration

  2. soluble transferrin receptor

    Time frame: Study day 1

    soluble transferrin receptor concentration in serum

  3. C-reactive protein

    Time frame: Study day 1

    C-reactive protein concentration in serum

  4. alpha(1)-acid-glycoprotein

    Time frame: Study day 1

    alpha(1)-acid-glycoprotein concentration in serum

Sponsors and collaborators

Lead sponsor

Isabelle Herter-Aeberli

Other

Collaborators

  • Jomo Kenyatta University of Agriculture and Technology

Registry information

Official study title

Defining the Serum Ferritin Concentration in Kenyan Women and Their Preschool Children at Which the Body Senses Iron Depletion and Begins to Upregulate Iron Absorption From the Diet

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 24, 2024
Registry last updated
May 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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