Iron-deficiencyNCT05609318
Imaging Intravenous Iron
An observational study of Iron-deficiency, run by University of Oxford at 1 site in United Kingdom.
Trial summary
The aim of this study is to track where the iron goes in different tissues in the hours, days and weeks after an intravenous iron infusion. We will track iron in tissues using MRI relaxometry parameters R1/R2/R2* which are well established as accurate indicators of tissue iron content. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Iron-deficiency
- Type of treatment
- Injection or infusion
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 Oct 2022to 31 Dec 2026
- How long will I take part?
- 6 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants are patients who require intravenous iron as part of their standard clinical care. They will be recruited from referrals to the Iron Deficiency Management Service (IDMS), part of Oxford University Hospitals NHS Foundation Trust (OUHFT). This service receives referrals from multiple sources across Oxfordshire. Patient referrals will be screened by members of the NHS Clinical team at IDMS to identify potentially eligible participants.
Who may be able to join
- Participant is willing and able to give informed consent for participation in the study.
- Aged 18 years or above.
- Anaemia (haemoglobin less than 120g/L for women and less than 130g/L for men) and/or confirmed iron deficiency (ferritin less than 100mcg/L and/or transferrin saturation less than 20%).
- Scheduled to receive intravenous iron for correction of iron deficiency.
Who cannot join
- Any MRI incompatible implants (e.g. cardiac, neuro, ocular implants, surgical clips, aneurysm clips, shrapnel/bullets)
- Pregnant or lactating participant
- Acute decompensated heart failure
- Unstable clinical status
- Any other medical conditions which would influence the reliability of the study results determined by the investigators.
- Any other contraindication to MRI to be confirmed by the qualified MRI operator, e.g. tattoos containing traces of metal.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Oxford Centre for Clinical Magnetic Resonance Research (OCMR)
Oxford, Oxfordshire, OX3 9DU
Samira Lakhal-Littleton, 01865 221172, samira.lakhal-littleton@dpag.ox.ac.uk
Vanessa Ferreira
About this study
Official title: Study of Tissue Iron Uptake in Iron-Deficient Patients Receiving Intravenous Iron Replacement Therapy: A Prospective Observational Study (STUDY)
The aim of this study is to track where the iron goes in different tissues in the hours, days and weeks after an intravenous iron infusion. We will track iron in tissues using MRI relaxometry parameters R1/R2/R2* which are well established as accurate indicators of tissue iron content.
Read the detailed description
This is a prospective, observational, study exploring the kinetics of tissue iron uptake following intravenous iron infusion (Ferinject), received as part of standard clinical care in a group of iron-deficient patients.
Participants will be recruited through the Iron Deficiency Management Service, part of the Oxford University Hospitals NHS Foundation Trust (OUHFT) . Participants will receive their intravenous iron infusion (Ferinject) as part of their standard clinical care by an NHS clinician. They will undergo all the study MRI scans and additional study procedures at the Oxford Centre for Clinical Magnetic Resonance Research (OCMR), which is based at the John Radcliffe Hospital and is part of the Division of Cardiovascular Medicine within the Radcliffe Department of Medicine at the University of Oxford.
Each participant will undergo 4 MRI scans; baseline, 3hours, 14 days and 42 days post intravenous iron infusion. Blood samples will also be collected at those timepoints for assessment of relevant heamatological and iron parameters.
- Conditions
- Iron-deficiency
- 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.
| Study group | Role | What they receive |
|---|---|---|
| iron-deficient | patients prescribed intravenous iron infusion for the treatment of iron deficiency as part of standard clinical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish the kinetics of iron uptake into the heart, liver, spleen, kidney, skeletal muscle and blood following a single intravenous iron infusion (Ferric carboxymaltose, Ferinject, 1000mg)
Changes from baseline in multi-organ magnetic resonance relaxometries (delta R1/R2/R2* (seconds) for each participant.
Measured: baseline, 3hr, 14 days and 42 days post intravenous iron infusion
Secondary outcomes (1)
Determine the effects of iron infusion (Ferric carboxymaltose, Ferinject, 1000mg) on serum iron indices and serum markers of tissue iron damage.
Change from baseline in:
- Serum iron indices: iron (uM), ferritin (mg/L), transferrin saturation (%), non-transferrin bound iron (uM)
- Serum markers of tissue iron damage, including but not limited to lipid peroxidation markers malondialdehyde (MDA in mM) and 4-Hydroxynonenal (HNE in mM)
Measured: baseline, 3hr, 14 days and 42 days post intravenous iron infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start29 Oct 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
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.
- More trials run by University of OxfordThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (estimated)
- Target duration
- 6 Weeks
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05609318
- Sponsor's protocol ID
- PID16038
- Status last verified
- May 2026
- First submitted
- 1 Nov 2022
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Tissue Iron Uptake in Iron-Deficient Patients Receiving Intravenous Iron Replacement Therapy: A Prospective Observational Study (STUDY)
- ClinicalTrials.gov ID
- NCT05609318
- Acronym / sponsor ID
- PID16038
- Conditions
- Iron-deficiency
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 29 Oct 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Nov 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 aim of this study is to track where the iron goes in different tissues in the hours, days and weeks after an intravenous iron infusion. We will track iron in tissues using MRI relaxometry parameters R1/R2/R2* which are well established as accurate indicators of tissue iron content.
Detailed description
This is a prospective, observational, study exploring the kinetics of tissue iron uptake following intravenous iron infusion (Ferinject), received as part of standard clinical care in a group of iron-deficient patients.
Participants will be recruited through the Iron Deficiency Management Service, part of the Oxford University Hospitals NHS Foundation Trust (OUHFT) . Participants will receive their intravenous iron infusion (Ferinject) as part of their standard clinical care by an NHS clinician. They will undergo all the study MRI scans and additional study procedures at the Oxford Centre for Clinical Magnetic Resonance Research (OCMR), which is based at the John Radcliffe Hospital and is part of the Division of Cardiovascular Medicine within the Radcliffe Department of Medicine at the University of Oxford.
Each participant will undergo 4 MRI scans; baseline, 3hours, 14 days and 42 days post intravenous iron infusion. Blood samples will also be collected at those timepoints for assessment of relevant heamatological and iron parameters.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| iron-deficient | – | –patients prescribed intravenous iron infusion for the treatment of iron deficiency as part of standard clinical care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants are patients who require intravenous iron as part of their standard clinical care. They will be recruited from referrals to the Iron Deficiency Management Service (IDMS), part of Oxford University Hospitals NHS Foundation Trust (OUHFT). This service receives referrals from multiple sources across Oxfordshire. Patient referrals will be screened by members of the NHS Clinical team at IDMS to identify potentially eligible participants.
Key inclusion criteria (4 listed)
- Participant is willing and able to give informed consent for participation in the study.
- Aged 18 years or above.
- Anaemia (haemoglobin less than 120g/L for women and less than 130g/L for men) and/or confirmed iron deficiency (ferritin less than 100mcg/L and/or transferrin saturation less than 20%).
- Scheduled to receive intravenous iron for correction of iron deficiency.
Key exclusion criteria (6 listed)
- Any MRI incompatible implants (e.g. cardiac, neuro, ocular implants, surgical clips, aneurysm clips, shrapnel/bullets)
- Pregnant or lactating participant
- Acute decompensated heart failure
- Unstable clinical status
- Any other medical conditions which would influence the reliability of the study results determined by the investigators.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To establish the kinetics of iron uptake into the heart, liver, spleen, kidney, skeletal muscle and blood following a single intravenous iron infusion (Ferric carboxymaltose, Ferinject, 1000mg)
Time frame: baseline, 3hr, 14 days and 42 days post intravenous iron infusion
Changes from baseline in multi-organ magnetic resonance relaxometries (delta R1/R2/R2* (seconds) for each participant.
1 secondary outcome
Determine the effects of iron infusion (Ferric carboxymaltose, Ferinject, 1000mg) on serum iron indices and serum markers of tissue iron damage.
Time frame: baseline, 3hr, 14 days and 42 days post intravenous iron infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
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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.
Oxford Centre for Clinical Magnetic Resonance Research (OCMR)
Oxford, United Kingdom
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Iron-deficiency, run by University of Oxford 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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 11 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To establish the kinetics of iron uptake into the heart, liver, spleen, kidney, skeletal muscle and blood following a single intravenous iron infusion (Ferric carboxymaltose, Ferinject, 1000mg) (time frame: baseline, 3hr, 14 days and 42 days post intravenous iron infusion). 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 11 May 2026.