Iron Deficiency Anaemia Due to Dietary CausesBOIsNCT07563686
Measuring Iron Bioavailability From Oral Iron Supplements in Healthy Pre-menopausal Women Using Stable Isotopes
A study testing 5mg Spatone, 10mg Spatone and 15mg Spatone in people with Iron Deficiency Anaemia Due to Dietary Causes, run by King's College London at 1 site in United Kingdom.
Trial summary
In this study the investigators will compare iron absorption from 3 doses of iron (5, 10, 15 mg, given as either Spatone™ or ferrous sulphate). Our primary objective is to determine iron absorption from each preparation by measuring stable isotope (57Fe) incorporation into haemoglobin. Read more about this study
- Who is it for?
- Ages 19 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiency Anaemia Due to Dietary Causes
- What is being tested?
- 5mg Spatone, 10mg Spatone and 15mg Spatone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Jan 2024to 31 Jan 2026
- 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 19 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy pre-menopausal women
- Aged 19-49 years
- With low iron stores (below 30 μg/L serum ferritin; normal range 30-100 μg/L).
Who cannot join
- Allergy to iron supplements
- BMI above 25
- Pregnant
- Post-menopausal women
- History of alcohol or substance abuse
- Reported history of CVD, diabetes, cancer, kidney, liver or intestinal disease, gastrointestinal disorder
- Use of drugs likely to alter gastrointestinal function
- Donated blood recently (within the last 3 months prior to screening visit)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
King's College London
London, Greater London, SE1 9NH
About this study
Official title: Randomised Cross Over Study Measuring Iron Bioavailability From Oral Iron Supplements in Healthy Pre-menopausal Women Using Stable Isotopes
In this study the investigators will compare iron absorption from 3 doses of iron (5, 10, 15 mg, given as either Spatone™ or ferrous sulphate). Our primary objective is to determine iron absorption from each preparation by measuring stable isotope (57Fe) incorporation into haemoglobin.
Read the detailed description
The study is designed to comprehensively evaluate iron absorption by directly comparing the efficacy of Spatone™ with that of ferrous sulphate. It aims to gather dose-response information to understand how varying doses influence iron absorption. Additionally, the study seeks to investigate the impact of iron absorption on serum hepcidin levels, which is a significant factor as elevated hepcidin levels can inhibit both the absorption and utilization of iron. Understanding these dynamics is vital for improving treatments for conditions related to iron deficiency and for optimizing iron supplementation strategies. Three doses of iron either as Spatone™ or ferrous sulphate will be given to each participant. Our hypotheses are: 1. There will be a dose-dependent decrease in fractional iron absorption from both Spatone™ and ferrous sulphate preparations; 2. There will be no significant difference in iron absorption between Spatone™ and ferrous sulphate; 3. Spatone™ and ferrous sulphate will not affect hepcidin levels, even at the highest dose of each preparation used in this study.
- Being tested
- 5mg Spatone, 10mg Spatone, 15mg Spatone, 5mg ferrous sulphate, 10mg ferrous sulphate
- Keywords
- iron deficiency anaemia
- 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.
5mg SpatoneDietary supplement
5mg Spatone
10mg SpatoneDietary supplement
10mg Spatone
15mg SpatoneDietary supplement
15mg Spatone
5mg ferrous sulphateDietary supplement
5mg ferrous sulphate
10mg ferrous sulphateDietary supplement
10 mg ferrous sulphate
15mg ferrous sulphateDietary supplement
15mg ferrous sulphate
| Study group | Role | What they receive |
|---|---|---|
| SP5 | Experimental | Spatone 5mg Receives: Dietary Supplement: 5mg Spatone |
| 10mg Spatone | Experimental | 10mg spatone Receives: Dietary Supplement: 10mg Spatone |
| 15mg Spatone | Experimental | 15mg Spatone Receives: Dietary Supplement: 15mg Spatone |
| 5mg Ferrous sulphate | Experimental | 5mg ferrous sulphate Receives: Dietary Supplement: 5mg ferrous sulphate |
| 10mg Ferrous sulphate | Experimental | 10 mg ferrous sulphate Receives: Dietary Supplement: 10mg ferrous sulphate |
| 15mg Ferrous sulphate | Experimental | 15mg ferrous sulphate Receives: Dietary Supplement: 15mg ferrous sulphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Iron Status Indicators
The baseline blood sample, taken prior to the first intervention, will establish the participant's iron status before any treatment is administered. This includes, but is not limited to, serum ferritin, haemoglobin, and transferrin saturation.
Post-Intervention Iron Status: Subsequent blood samples, taken two weeks after each intervention will be analysed to assess iron absorption from each supplemental iron preparation.
Measured: Day 1, Day 14, Day 28, Day 42, Day 56, Day 70, Day 84
Secondary outcomes (1)
Serum hepcidin levels
An additional blood sample will be collected the day after the administration of the 15 mg iron dose to assess the serum hepcidin response to high-dose iron from both ferrous sulphate and Spatone™.
Measured: Baseline (Day 1) before 15mg supplementation and Day 2 ( 24 hours after 15mg supplementation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start13 Jan 2024
- Primary completion31 Mar 2025
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Deficiency Anaemia Due to Dietary CausesStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This will be a Randomised controlled cross over study measuring iron bioavailability from oral iron supplement. In this study the investigators will compare iron absorption from 3 doses of iron (5, 10, 15 mg, given as either Spatone™ or ferrous sulphate). Each volunteer will undergo six interventions, with a two-week interval between them. On the day of each intervention, a blood sample will be taken to measure either baseline levels of iron in haemoglobin or iron absorbed and incorporated into haemoglobin from the previous intervention administered two weeks prior.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07563686
- Sponsor's protocol ID
- HR/DP-23/24-40266
- Acronym
- BOIs
- Status last verified
- Feb 2025
- First submitted
- 5 Feb 2026
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Cross Over Study Measuring Iron Bioavailability From Oral Iron Supplements in Healthy Pre-menopausal Women Using Stable Isotopes
- ClinicalTrials.gov ID
- NCT07563686
- Acronym / sponsor ID
- BOIs / HR/DP-23/24-40266
- Keywords
- iron deficiency anaemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- 13 Jan 2024 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 4 May 2026 (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.
In this study the investigators will compare iron absorption from 3 doses of iron (5, 10, 15 mg, given as either Spatone™ or ferrous sulphate). Our primary objective is to determine iron absorption from each preparation by measuring stable isotope (57Fe) incorporation into haemoglobin.
Detailed description
The study is designed to comprehensively evaluate iron absorption by directly comparing the efficacy of Spatone™ with that of ferrous sulphate. It aims to gather dose-response information to understand how varying doses influence iron absorption. Additionally, the study seeks to investigate the impact of iron absorption on serum hepcidin levels, which is a significant factor as elevated hepcidin levels can inhibit both the absorption and utilization of iron. Understanding these dynamics is vital for improving treatments for conditions related to iron deficiency and for optimizing iron supplementation strategies. Three doses of iron either as Spatone™ or ferrous sulphate will be given to each participant. Our hypotheses are: 1. There will be a dose-dependent decrease in fractional iron absorption from both Spatone™ and ferrous sulphate preparations; 2. There will be no significant difference in iron absorption between Spatone™ and ferrous sulphate; 3. Spatone™ and ferrous sulphate will not affect hepcidin levels, even at the highest dose of each preparation used in this study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
- Model description
- This will be a Randomised controlled cross over study measuring iron bioavailability from oral iron supplement. In this study the investigators will compare iron absorption from 3 doses of iron (5, 10, 15 mg, given as either Spatone™ or ferrous sulphate). Each volunteer will undergo six interventions, with a two-week interval between them. On the day of each intervention, a blood sample will be taken to measure either baseline levels of iron in haemoglobin or iron absorbed and incorporated into haemoglobin from the previous intervention administered two weeks prior.
| Arm | Type | Receives |
|---|---|---|
| SP5 | Experimental | Dietary Supplement: 5mg SpatoneSpatone 5mg |
| 10mg Spatone | Experimental | Dietary Supplement: 10mg Spatone10mg spatone |
| 15mg Spatone | Experimental | Dietary Supplement: 15mg Spatone15mg Spatone |
| 5mg Ferrous sulphate | Experimental | Dietary Supplement: 5mg ferrous sulphate5mg ferrous sulphate |
| 10mg Ferrous sulphate | Experimental | Dietary Supplement: 10mg ferrous sulphate10 mg ferrous sulphate |
| 15mg Ferrous sulphate | Experimental | Dietary Supplement: 15mg ferrous sulphate15mg ferrous sulphate |
Who may qualify
- Ages
- 19 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy pre-menopausal women
- Aged 19-49 years
- With low iron stores (below 30 μg/L serum ferritin; normal range 30-100 μg/L).
Key exclusion criteria (8 listed)
- Allergy to iron supplements
- BMI above 25
- Pregnant
- Post-menopausal women
- History of alcohol or substance abuse
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 |
|---|---|---|
| 5mg Spatone5mg Spatone | Dietary supplement | SP5 |
| 10mg Spatone10mg Spatone | Dietary supplement | 10mg Spatone |
| 15mg Spatone15mg Spatone | Dietary supplement | 15mg Spatone |
| 5mg ferrous sulphate5mg ferrous sulphate | Dietary supplement | 5mg Ferrous sulphate |
| 10mg ferrous sulphate10 mg ferrous sulphate | Dietary supplement | 10mg Ferrous sulphate |
| 15mg ferrous sulphate15mg ferrous sulphate | Dietary supplement | 15mg Ferrous sulphate |
Primary outcome
Iron Status Indicators
Time frame: Day 1, Day 14, Day 28, Day 42, Day 56, Day 70, Day 84
The baseline blood sample, taken prior to the first intervention, will establish the participant's iron status before any treatment is administered. This includes, but is not limited to, serum ferritin, haemoglobin, and transferrin saturation. Post-Intervention Iron Status: Subsequent blood samples, taken two weeks after each intervention will be analysed to assess iron absorption from each supplemental iron preparation.
1 secondary outcome
Serum hepcidin levels
Time frame: Baseline (Day 1) before 15mg supplementation and Day 2 ( 24 hours after 15mg supplementation)
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 4 May 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Iron Deficiency Anaemia Due to Dietary Causes
Not yet recruitingPhase 4
The Role of Ferric Carboxymaltose in the Treatment of Pediatric Iron Deficiency Anemia in the Emergency Department
Iron Deficiency Anemia Associated With Non-Dialysis Dependent Chronic Kidney Disease, Iron Deficiency Anaemia Due to Dietary Causes
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 5mg Spatone, 10mg Spatone and 15mg Spatone in people with Iron Deficiency Anaemia Due to Dietary Causes, run by King's College London at 1 site in United Kingdom.
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 3 inclusion and 8 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 4 May 2026. 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 United Kingdom. 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?
Iron Status Indicators (time frame: Day 1, Day 14, Day 28, Day 42, Day 56, Day 70, Day 84). 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 4 May 2026.