Iron Deficiency AnemiaPhase 4FERIDANCT05708170
Impact of Intravenous Iron on Musculoskeletal Function in Older Adults
A Phase 4 study testing Ferinject and Ferrous Sulfate 200 MG in people with Iron Deficiency Anemia, run by Liverpool Hope University.
Trial summary
Anaemia is a risk factor for functional decline and frailty in older adults including decreased physical performance and muscle strength, increased hospitalisation risk and mortality, falls, and poorer recovery from activities of daily living. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Iron Deficiency Anemia
- What is being tested?
- Ferinject and Ferrous Sulfate 200 MG
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2023to Jan 2027
- Phase
- Phase 4
- 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 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Anaemia attributable to iron deficiency
- Haemoglobin < 120 g/L in women, Hb < 130 g/L in men
- Ferritin ≤100 ng/mL or ≤300 ng/mL if transferrin saturation (TSAT) ≤30%
- Age ≥ 60 to 85 years
- Ambulatory individuals
- Written informed consent
Who cannot join
- Patients already taking intravenous or oral iron
- BMI > 40 kg/m²
- Uncontrolled hypertension/ diabetes
- Potential medication interactions
- Hemochromatosis or iron storage disorders
- Recent treatment with IV antibiotics or red blood cell transfusion
Show all 15Show fewer
- Dialysis dependent
- History of malignancy
- Pregnant or lactating women
- Severe hepatic and renal dysfunction
- Advanced cardiovascular disease and COPD
- Advanced Neuromuscular disorder
- Obvious cognitive disability and psychological illness
- Current treatment with systemic steroids or any other substantive medication
- Alcohol or any other drug abuse
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Impact of Intravenous Iron (Ferinject) on Musculoskeletal Function Profiles in Older Adults With Iron Deficiency Anaemia (IDA)
Anaemia is a risk factor for functional decline and frailty in older adults including decreased physical performance and muscle strength, increased hospitalisation risk and mortality, falls, and poorer recovery from activities of daily living. Despite a major gap in human studies, research in animals has demonstrated an interrelationship between iron deficiency anaemia and deteriorated functional capacity and physical performance particularly in older adults. Iron deficiency and associated anaemia is a frequent accompanier of debilitating chronic diseases such as heart failure and chronic lung diseases. These conditions, more commonly seen in older patients, are strongly linked to deterioration in physical function, reduced skeletal muscle mass and quality, frailty, and poor quality of life. Exercise intolerance is also a common feature of these conditions as iron deficiency impairs the capacity of carrying oxygen leading to inability to sustain physical activities. Furthermore, the age-related decline in the muscle mass and quality (so called sarcopenia) and associated frailty has rapidly become a major health concern in the older adults particularly when accompanied by other chronic diseases. Recently, there has been an increasing interest in exploring the role of iron as a causative factor in the development of sarcopenia and related frailty.
In summary, there is a substantial gap of evidence whether Iron repletion leads to meaningful enhancements in the skeletal muscle function and physical performance in older adults suffering from iron deficiency anaemia. This study will investigate the impact of a standard care intervention (intravenous iron therapy) on muscular function and physical performance in older patients through a range of laboratory assessments.
Read the detailed description
The study will recruit two groups of stable patients (although likely with chronic diseases) with established iron deficiency anaemia through Aintree Hospital NHS Trust clinics. Fifty patients aged 60-85 years will be recruited into each group:
- Intravenous iron therapy group: This group will receive intravenous iron calculated based on body weight and level of anaemia (hemoglobin concentration), as per the iron therapy's SPC
- Active Control Group: This group will receive oral ferrous sulphate prescribed by their GP Randmisation: Simple randomisation/parallel assignment/single-blinded
Identified patients with iron deficiency anaemia will receive an invitation to participate in the study together with a Patient Information Sheet clearly explaining different aspects of the research project. Each participant will require to attend the School of Health Sciences' laboratories (Liverpool Hope University) on four different occasions (once before the intervention and three times after receiving the iron therapy) throughout a 3-year period to complete multiple assessments in relation to basic blood tests and musculoskeletal function and physical performance. In addition to this, participants in the first group will require to attend the Aintree Hospital NHS Trust clinics on one occasion to receive a single-dose intravenous iron.
The study will broadly investigate musculoskeletal function (health) and physical performance by means of muscle quality, muscle mass, muscle strength, muscle activation and fatigue levels, gait quality, muscle physiology (level of oxygen carried into the muscles), and functional questionnaires prior to, during, and after iron therapy. In addition to this, changes in patients' quality of life in each group will be assessed through administration of validated questionnaires.
The data will be analysed at the end of the study to identify any significant and clinically meaningful changes in the musculoskeletal function, physical performance, and health-related quality of life resulted from the iron therapy in each group while also comparing such changes between the two study groups.
- Conditions
- Iron Deficiency Anemia
- Being tested
- Ferinject, Ferrous Sulfate 200 MG
- Keywords
- Iron Deficiency Anaemia, Skeletal Muscle Function, Musculoskeletal, Ageing
- 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.
FerinjectDrug
Also called ferric carboxymaltose
Ferinject Therapy Group: each patient's Iron need for repletion by the Ferinject will be determined using product SPC dosing based on patient's body weight and Hb level. Accordingly, the appropriate dose of Ferinject will be administered while ensuring that a single administration will not exceed:
- 15 mg iron/kg body weight (for administration by intravenous injection) or 20 mg iron/kg body weight (for administration by intravenous infusion)
- 1,000 mg of iron (20 mL Ferinject) The cumulative dose of Ferinject per week will not exceed 1,000 mg of iron (20 mL Ferinject).
Ferrous Sulfate 200 MGDrug
Also called oral iron
Active Control Group (standard care excl. IV Iron): Oral Ferrous sulphate 200 mg three times daily.
| Study group | Role | What they receive |
|---|---|---|
| Intravenous iron therapy group | Experimental | This group will receive intravenous iron calculated based on body weight and level of anaemia (hemoglobin concentration), as per the iron therapy's SPC. Receives: Drug: Ferinject |
| Active Control Group | Active comparator | This group will receive oral ferrous sulphate prescribed by their GP Randmisation: Simple randomisation/parallel assignment/single-blinded Receives: Drug: Ferrous Sulfate 200 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Quality Index (MQI)
Muscle strength relative to volume of the muscle mass generating the force
Measured: "through study completion, an average of 2 year"
Secondary outcomes (16)
Health-history Questionnaire
Questionnaire to document participant health history
Measured: Baseline
International Physical Activity Questionnaire-IPAQ)
Questionnaire to determine the level of physical activity
Measured: Baseline
Blood Iron Profile
Blood analysis including Hemoglobin, Iron, Ferritin, and Transferrin
Measured: "Through study completion, an average of 2 year"
Upper Extremity Strength (in Newtons)
Dynamometry to measure upper extremity (Grip and shoulder forward flexion) strength
Measured: "Through study completion, an average of 2 year"
Lower Extremity Muscle Strength (in Newtons)
Dynamometry to measure lower extremity (Knee extension) strength
Measured: "Through study completion, an average of 2 year"
Skeletal Muscle Mass (kg)
Bio-Impedance (BIA) to measure the skeletal muscle mass (kg)
Measured: "Through study completion, an average of 2 year"
Muscle Fatigue
Electromyographic (EMG) assessment of localised muscle fatigue
Measured: "Through study completion, an average of 2 year"
Muscle Activation
Electromyographic (EMG) assessment of muscle activity level
Measured: "through study completion, an average of 2 year"
Gait Analysis
3-Dimensional Motion Capture to assess gait quality
Measured: "Through study completion, an average of 2 year"
Short Battery of Physical Performance (SBPP)
A validated test for assessing physcial and functional capacity
Measured: "through study completion, an average of 2 year"
Mitochondrial Function
Near-infrared spectroscopy (NIRS) to investigate quality of oxidation in muscles
Measured: "through study completion, an average of 2 year"
The 12-Item Short Form Health Survey (SF-12)
A patient-rated questionnaire to assess the Quality of Life
Measured: "Through study completion, an average of 2 year"
The Hospital Anxiety and Depression Scale (HADS)
A patient-rated questionnaire to assess anxiety and Depression
Measured: "Through study completion, an average of 2 year"
The Sarcopenia Quality of Life (SarQoL)
A patient-rated questionnaire to assess Sarcopenia-specific quality of life
Measured: "through study completion, an average of 2 year"
The Upper Extremity Functional Index (UEFI)
A patient-rated questionnaire to assess Upper Extremity Function
Measured: "through study completion, an average of 2 year"
The Lower Extremity Functional Index (UEFI)
A patient-rated questionnaire to assess Lower Extremity Function
Measured: "through study completion, an average of 2 year"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study startJan 2023 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Deficiency AnemiaStudies 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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liverpool Hope University
- Sponsor type
- University, hospital or other
- Collaborators
- Liverpool University Hospitals NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05708170
- Sponsor's protocol ID
- LHU-FERIDA
- Acronym
- FERIDA
- Status last verified
- Aug 2022
- First submitted
- 17 Oct 2022
- Last updated
- 1 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NK
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Intravenous Iron (Ferinject) on Musculoskeletal Function Profiles in Older Adults With Iron Deficiency Anaemia (IDA)
- ClinicalTrials.gov ID
- NCT05708170
- Acronym / sponsor ID
- FERIDA / LHU-FERIDA
- Conditions
- Iron Deficiency Anemia
- Keywords
- Iron Deficiency Anaemia, Skeletal Muscle Function, Musculoskeletal, Ageing
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Liverpool Hope UniversityUniversity, hospital or other
- Collaborators
- Liverpool University Hospitals NHS Foundation Trust
- Study start
- Jan 2023 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 1 Feb 2023 (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.
Anaemia is a risk factor for functional decline and frailty in older adults including decreased physical performance and muscle strength, increased hospitalisation risk and mortality, falls, and poorer recovery from activities of daily living. Despite a major gap in human studies, research in animals has demonstrated an interrelationship between iron deficiency anaemia and deteriorated functional capacity and physical performance particularly in older adults. Iron deficiency and associated anaemia is a frequent accompanier of debilitating chronic diseases such as heart failure and chronic lung diseases. These conditions, more commonly seen in older patients, are strongly linked to deterioration in physical function, reduced skeletal muscle mass and quality, frailty, and poor quality of life. Exercise intolerance is also a common feature of these conditions as iron deficiency impairs the capacity of carrying oxygen leading to inability to sustain physical activities. Furthermore, the age-related decline in the muscle mass and quality (so called sarcopenia) and associated frailty has rapidly become a major health concern in the older adults particularly when accompanied by other chronic diseases. Recently, there has been an increasing interest in exploring the role of iron as a causative factor in the development of sarcopenia and related frailty.
In summary, there is a substantial gap of evidence whether Iron repletion leads to meaningful enhancements in the skeletal muscle function and physical performance in older adults suffering from iron deficiency anaemia. This study will investigate the impact of a standard care intervention (intravenous iron therapy) on muscular function and physical performance in older patients through a range of laboratory assessments.
Detailed description
The study will recruit two groups of stable patients (although likely with chronic diseases) with established iron deficiency anaemia through Aintree Hospital NHS Trust clinics. Fifty patients aged 60-85 years will be recruited into each group:
- Intravenous iron therapy group: This group will receive intravenous iron calculated based on body weight and level of anaemia (hemoglobin concentration), as per the iron therapy's SPC
- Active Control Group: This group will receive oral ferrous sulphate prescribed by their GP Randmisation: Simple randomisation/parallel assignment/single-blinded
Identified patients with iron deficiency anaemia will receive an invitation to participate in the study together with a Patient Information Sheet clearly explaining different aspects of the research project. Each participant will require to attend the School of Health Sciences' laboratories (Liverpool Hope University) on four different occasions (once before the intervention and three times after receiving the iron therapy) throughout a 3-year period to complete multiple assessments in relation to basic blood tests and musculoskeletal function and physical performance. In addition to this, participants in the first group will require to attend the Aintree Hospital NHS Trust clinics on one occasion to receive a single-dose intravenous iron.
The study will broadly investigate musculoskeletal function (health) and physical performance by means of muscle quality, muscle mass, muscle strength, muscle activation and fatigue levels, gait quality, muscle physiology (level of oxygen carried into the muscles), and functional questionnaires prior to, during, and after iron therapy. In addition to this, changes in patients' quality of life in each group will be assessed through administration of validated questionnaires.
The data will be analysed at the end of the study to identify any significant and clinically meaningful changes in the musculoskeletal function, physical performance, and health-related quality of life resulted from the iron therapy in each group while also comparing such changes between the two study groups.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous iron therapy group | Experimental | Drug: FerinjectThis group will receive intravenous iron calculated based on body weight and level of anaemia (hemoglobin concentration), as per the iron therapy's SPC. |
| Active Control Group | Active comparator | Drug: Ferrous Sulfate 200 MGThis group will receive oral ferrous sulphate prescribed by their GP Randmisation: Simple randomisation/parallel assignment/single-blinded |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Anaemia attributable to iron deficiency
- Haemoglobin < 120 g/L in women, Hb < 130 g/L in men
- Ferritin ≤100 ng/mL or ≤300 ng/mL if transferrin saturation (TSAT) ≤30%
- Age ≥ 60 to 85 years
- Ambulatory individuals
Key exclusion criteria (15 listed)
- Patients already taking intravenous or oral iron
- BMI > 40 kg/m²
- Uncontrolled hypertension/ diabetes
- Potential medication interactions
- Hemochromatosis or iron storage disorders
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 |
|---|---|---|
| FerinjectAlso: ferric carboxymaltoseFerinject Therapy Group: each patient's Iron need for repletion by the Ferinject will be determined using product SPC dosing based on patient's body weight and Hb level. Accordingly, the appropriate dose of Ferinject will be administered while ensuring that a single administration will not exceed: * 15 mg iron/kg body weight (for administration by intravenous injection) or 20 mg iron/kg body weight (for administration by intravenous infusion) * 1,000 mg of iron (20 mL Ferinject) The cumulative dose of Ferinject per week will not exceed 1,000 mg of iron (20 mL Ferinject). | Drug | Intravenous iron therapy group |
| Ferrous Sulfate 200 MGAlso: oral ironActive Control Group (standard care excl. IV Iron): Oral Ferrous sulphate 200 mg three times daily. | Drug | Active Control Group |
Primary outcome
Muscle Quality Index (MQI)
Time frame: "through study completion, an average of 2 year"
Muscle strength relative to volume of the muscle mass generating the force
16 secondary outcomes
Health-history Questionnaire
Time frame: Baseline
International Physical Activity Questionnaire-IPAQ)
Time frame: Baseline
Blood Iron Profile
Time frame: "Through study completion, an average of 2 year"
Upper Extremity Strength (in Newtons)
Time frame: "Through study completion, an average of 2 year"
Lower Extremity Muscle Strength (in Newtons)
Time frame: "Through study completion, an average of 2 year"
Skeletal Muscle Mass (kg)
Time frame: "Through study completion, an average of 2 year"
Muscle Fatigue
Time frame: "Through study completion, an average of 2 year"
Muscle Activation
Time frame: "through study completion, an average of 2 year"
Gait Analysis
Time frame: "Through study completion, an average of 2 year"
Short Battery of Physical Performance (SBPP)
Time frame: "through study completion, an average of 2 year"
Mitochondrial Function
Time frame: "through study completion, an average of 2 year"
The 12-Item Short Form Health Survey (SF-12)
Time frame: "Through study completion, an average of 2 year"
The Hospital Anxiety and Depression Scale (HADS)
Time frame: "Through study completion, an average of 2 year"
The Sarcopenia Quality of Life (SarQoL)
Time frame: "through study completion, an average of 2 year"
The Upper Extremity Functional Index (UEFI)
Time frame: "through study completion, an average of 2 year"
The Lower Extremity Functional Index (UEFI)
Time frame: "through study completion, an average of 2 year"
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 1 Feb 2023.
- ISRCTNLink provided by the sponsor.
- NHS/HRALink provided by the sponsor.
- WHO - International Trial Registry PlatformLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. NK
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ferinject and Ferrous Sulfate 200 MG in people with Iron Deficiency Anemia, run by Liverpool Hope University.
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 6 inclusion and 15 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: opening soon, as of the sponsor's last update on 1 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Professor Khaiyat (00441512913262, alizado@hope.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle Quality Index (MQI) (time frame: "through study completion, an average of 2 year"). 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 1 Feb 2023.