Healthy VolunteerNCT06655909
Serum Ferritin Concentration in Kenyan Women and Their Preschool Children at Which the Body Begins to Upregulate Iron Absorption From the Diet
A study testing consumption of maize porridge containing stable iron isotope in people with Healthy Volunteer and Mothers, run by Isabelle Herter-Aeberli at 1 site in Kenya.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer, Mothers, Preschool Children
- What is being tested?
- consumption of maize porridge containing stable iron isotope
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 275 participants
- Where
- 1 siteKenya
- Study dates
- 23 Oct 2024to 13 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- < 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)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Healthy Volunteer, Mothers, Preschool Children
- Being tested
- consumption of maize porridge containing stable iron isotope
- Keywords
- iron absorption, serum ferritin, maize porridge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
consumption of maize porridge containing stable iron isotopeOther
consumption of maize porridge containing stable iron isotope
| Study group | Role | What they receive |
|---|---|---|
| mothers | Other | healthy volunteers Receives: Other: consumption of maize porridge containing stable iron isotope |
| preschool children | Other | healthy volunteers Receives: Other: consumption of maize porridge containing stable iron isotope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fractional iron absorption
Erythrocyte iron incorporation
Measured: Study day 14
Secondary outcomes (4)
Serum ferritin
Serum ferritin concentration
Measured: Study day 1
soluble transferrin receptor
soluble transferrin receptor concentration in serum
Measured: Study day 1
C-reactive protein
C-reactive protein concentration in serum
Measured: Study day 1
alpha(1)-acid-glycoprotein
alpha(1)-acid-glycoprotein concentration in serum
Measured: Study day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start23 Oct 2024
- Primary completion13 Nov 2024
- Study completion13 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 275 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isabelle Herter-Aeberli
- Sponsor type
- University, hospital or other
- Collaborators
- Jomo Kenyatta University of Agriculture and Technology
- Responsible party
- Sponsor-investigator, Isabelle Herter-Aeberli, Swiss Federal Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06655909
- Sponsor's protocol ID
- MOCHA
- Status last verified
- May 2025
- First submitted
- 22 Oct 2024
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06655909
- Acronym / sponsor ID
- MOCHA
- Conditions
- Healthy Volunteer, Mothers, Preschool Children
- Keywords
- iron absorption, serum ferritin, maize porridge
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 275 participants (actual)
- Lead sponsor
- Isabelle Herter-AeberliUniversity, hospital or other
- Collaborators
- Jomo Kenyatta University of Agriculture and Technology
- Study start
- 23 Oct 2024 (actual)
- Primary completion
- 13 Nov 2024 (actual)
- Study completion
- 13 Nov 2024 (actual)
- First posted
- 24 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mothers | Other | Other: consumption of maize porridge containing stable iron isotopehealthy volunteers |
| preschool children | Other | Other: consumption of maize porridge containing stable iron isotopehealthy volunteers |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- < 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| consumption of maize porridge containing stable iron isotopeconsumption of maize porridge containing stable iron isotope | Other | mothers, preschool children |
Primary outcome
Fractional iron absorption
Time frame: Study day 14
Erythrocyte iron incorporation
4 secondary outcomes
Serum ferritin
Time frame: Study day 1
soluble transferrin receptor
Time frame: Study day 1
C-reactive protein
Time frame: Study day 1
alpha(1)-acid-glycoprotein
Time frame: Study day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing consumption of maize porridge containing stable iron isotope in people with Healthy Volunteer and Mothers, run by Isabelle Herter-Aeberli at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fractional iron absorption (time frame: Study day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025.