Iron-deficiencyNCT05266703
Defining the Serum Ferritin Concentration in Kenyan Women at Which the Body Senses Iron Depletion and Begins to Upregulate Iron Absorption
A study testing Isotopically labelled iron sulfate 15mg in people with Iron-deficiency and Ferritin Threshold, run by Swiss Federal Institute of Technology at 1 site in Kenya.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 28 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron-deficiency, Ferritin Threshold, Iron Absorption
- What is being tested?
- Isotopically labelled iron sulfate 15mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteKenya
- Study dates
- 18 Feb 2022to 30 Jun 2023
- 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 28 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Isotopically labelled iron sulfate 15mg
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isotopically labelled iron sulfate 15mgOther
test drink: water containing isotopic iron solution with vitamin C
| Study group | Role | What they receive |
|---|---|---|
| Isotopically labelled iron sulfate 15mg | Other | Not described Receives: Other: Isotopically labelled iron sulfate 15mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fractional iron absorption
shift in iron isotopic ratios measured in red blood cells
Measured: Day 14
Secondary outcomes (24)
Plasma Ferritin
Measured: Day 0
Plasma Ferritin
Measured: 4 months after isotope administration
Plasma Ferritin
Measured: 8 months after isotope administration
Plasma Ferritin
Measured: 12 months after isotope administration
soluble transferrin receptor
Measured: Day 0
soluble transferrin receptor
Measured: 4 months after isotope administration
soluble transferrin receptor
Measured: 8 months after isotope administration
soluble transferrin receptor
Measured: 12 months after isotope administration
C-reactive protein
Measured: Day 0
C-reactive protein
Measured: 4 months after isotope administration
C-reactive protein
Measured: 8 months after isotope administration
C-reactive protein
Measured: 12 months after isotope administration
alpha-1-glycoprotein
Measured: Day 0
alpha-1-glycoprotein
Measured: 4 months after isotope administration
alpha-1-glycoprotein
Measured: 8 months after isotope administration
alpha-1-glycoprotein
Measured: 12 months after isotope administration
Hemoglobin
Measured: Day 0
Hemoglobin
Measured: 4 months after isotope administration
Hemoglobin
Measured: 8 months after isotope administration
Hemoglobin
Measured: 12 months after isotope administration
Plasma Hepcidin
Measured: Day 0
Isotopic composition of red blood cells
shift in iron isotopic ratios measured in red blood cells
Measured: 4 months after isotope administration
Isotopic composition of red blood cells
shift in iron isotopic ratios measured in red blood cells
Measured: 8 months after isotope administration
Isotopic composition of red blood cells
shift in iron isotopic ratios measured in red blood cells
Measured: 12 months after isotope administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start18 Feb 2022
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron-deficiencyStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Jomo Kenyatta University of Agriculture and Technology
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05266703
- Sponsor's protocol ID
- PILLAR
- Status last verified
- Jan 2024
- First submitted
- 8 Feb 2022
- Last updated
- 25 Jan 2024
- 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 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining the Serum Ferritin Concentration in Kenyan Women at Which the Body Senses Iron Depletion and Begins to Upregulate Iron Absorption
- ClinicalTrials.gov ID
- NCT05266703
- Acronym / sponsor ID
- PILLAR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Collaborators
- Jomo Kenyatta University of Agriculture and Technology
- Study start
- 18 Feb 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 4 Mar 2022 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Isotopically labelled iron sulfate 15mg | Other | Other: Isotopically labelled iron sulfate 15mg |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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)
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 |
|---|---|---|
| Isotopically labelled iron sulfate 15mgtest drink: water containing isotopic iron solution with vitamin C | Other | Isotopically labelled iron sulfate 15mg |
Primary outcome
Fractional iron absorption
Time frame: Day 14
shift in iron isotopic ratios measured in red blood cells
24 secondary outcomes
Plasma Ferritin
Time frame: Day 0
Plasma Ferritin
Time frame: 4 months after isotope administration
Plasma Ferritin
Time frame: 8 months after isotope administration
Plasma Ferritin
Time frame: 12 months after isotope administration
soluble transferrin receptor
Time frame: Day 0
soluble transferrin receptor
Time frame: 4 months after isotope administration
soluble transferrin receptor
Time frame: 8 months after isotope administration
soluble transferrin receptor
Time frame: 12 months after isotope administration
C-reactive protein
Time frame: Day 0
C-reactive protein
Time frame: 4 months after isotope administration
C-reactive protein
Time frame: 8 months after isotope administration
C-reactive protein
Time frame: 12 months after isotope administration
alpha-1-glycoprotein
Time frame: Day 0
alpha-1-glycoprotein
Time frame: 4 months after isotope administration
alpha-1-glycoprotein
Time frame: 8 months after isotope administration
alpha-1-glycoprotein
Time frame: 12 months after isotope administration
Hemoglobin
Time frame: Day 0
Hemoglobin
Time frame: 4 months after isotope administration
Hemoglobin
Time frame: 8 months after isotope administration
Hemoglobin
Time frame: 12 months after isotope administration
Plasma Hepcidin
Time frame: Day 0
Isotopic composition of red blood cells
Time frame: 4 months after isotope administration
Isotopic composition of red blood cells
Time frame: 8 months after isotope administration
Isotopic composition of red blood cells
Time frame: 12 months after isotope administration
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 25 Jan 2024.
- Individual participant dataSharing planned: No
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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 Isotopically labelled iron sulfate 15mg in people with Iron-deficiency and Ferritin Threshold, run by Swiss Federal Institute of Technology 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 7 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 25 Jan 2024. 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: 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 25 Jan 2024.