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Impact of Intravenous Iron on Musculoskeletal Function in Older Adults (FERIDA)

Primary Purpose

Iron Deficiency Anemia

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Ferinject
Ferrous Sulfate 200 MG
Sponsored by
Liverpool Hope University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Iron Deficiency Anemia focused on measuring Iron Deficiency Anaemia, Skeletal Muscle Function, Musculoskeletal, Ageing

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Intravenous iron therapy group

    Active Control Group

    Arm Description

    This group will receive intravenous iron calculated based on body weight and level of anaemia (hemoglobin concentration), as per the iron therapy's SPC.

    This group will receive oral ferrous sulphate prescribed by their GP Randmisation: Simple randomisation/parallel assignment/single-blinded

    Outcomes

    Primary Outcome Measures

    Muscle Quality Index (MQI)
    Muscle strength relative to volume of the muscle mass generating the force

    Secondary Outcome Measures

    Health-history Questionnaire
    Questionnaire to document participant health history
    International Physical Activity Questionnaire-IPAQ)
    Questionnaire to determine the level of physical activity
    Blood Iron Profile
    Blood analysis including Hemoglobin, Iron, Ferritin, and Transferrin
    Upper Extremity Strength (in Newtons)
    Dynamometry to measure upper extremity (Grip and shoulder forward flexion) strength
    Lower Extremity Muscle Strength (in Newtons)
    Dynamometry to measure lower extremity (Knee extension) strength
    Skeletal Muscle Mass (kg)
    Bio-Impedance (BIA) to measure the skeletal muscle mass (kg)
    Muscle Fatigue
    Electromyographic (EMG) assessment of localised muscle fatigue
    Muscle Activation
    Electromyographic (EMG) assessment of muscle activity level
    Gait Analysis
    3-Dimensional Motion Capture to assess gait quality
    Short Battery of Physical Performance (SBPP)
    A validated test for assessing physcial and functional capacity
    Mitochondrial Function
    Near-infrared spectroscopy (NIRS) to investigate quality of oxidation in muscles
    The 12-Item Short Form Health Survey (SF-12)
    A patient-rated questionnaire to assess the Quality of Life
    The Hospital Anxiety and Depression Scale (HADS)
    A patient-rated questionnaire to assess anxiety and Depression
    The Sarcopenia Quality of Life (SarQoL)
    A patient-rated questionnaire to assess Sarcopenia-specific quality of life
    The Upper Extremity Functional Index (UEFI)
    A patient-rated questionnaire to assess Upper Extremity Function
    The Lower Extremity Functional Index (UEFI)
    A patient-rated questionnaire to assess Lower Extremity Function

    Full Information

    First Posted
    October 17, 2022
    Last Updated
    January 23, 2023
    Sponsor
    Liverpool Hope University
    Collaborators
    Liverpool University Hospitals NHS Foundation Trust
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05708170
    Brief Title
    Impact of Intravenous Iron on Musculoskeletal Function in Older Adults
    Acronym
    FERIDA
    Official Title
    Impact of Intravenous Iron (Ferinject) on Musculoskeletal Function Profiles in Older Adults With Iron Deficiency Anaemia (IDA)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2023 (Anticipated)
    Primary Completion Date
    August 2026 (Anticipated)
    Study Completion Date
    January 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Liverpool Hope University
    Collaborators
    Liverpool University Hospitals NHS Foundation Trust

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Iron Deficiency Anemia
    Keywords
    Iron Deficiency Anaemia, Skeletal Muscle Function, Musculoskeletal, Ageing

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intravenous iron therapy group
    Arm Type
    Experimental
    Arm Description
    This group will receive intravenous iron calculated based on body weight and level of anaemia (hemoglobin concentration), as per the iron therapy's SPC.
    Arm Title
    Active Control Group
    Arm Type
    Active Comparator
    Arm Description
    This group will receive oral ferrous sulphate prescribed by their GP Randmisation: Simple randomisation/parallel assignment/single-blinded
    Intervention Type
    Drug
    Intervention Name(s)
    Ferinject
    Other Intervention Name(s)
    ferric carboxymaltose
    Intervention Description
    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).
    Intervention Type
    Drug
    Intervention Name(s)
    Ferrous Sulfate 200 MG
    Other Intervention Name(s)
    oral iron
    Intervention Description
    Active Control Group (standard care excl. IV Iron): Oral Ferrous sulphate 200 mg three times daily.
    Primary Outcome Measure Information:
    Title
    Muscle Quality Index (MQI)
    Description
    Muscle strength relative to volume of the muscle mass generating the force
    Time Frame
    "through study completion, an average of 2 year"
    Secondary Outcome Measure Information:
    Title
    Health-history Questionnaire
    Description
    Questionnaire to document participant health history
    Time Frame
    Baseline
    Title
    International Physical Activity Questionnaire-IPAQ)
    Description
    Questionnaire to determine the level of physical activity
    Time Frame
    Baseline
    Title
    Blood Iron Profile
    Description
    Blood analysis including Hemoglobin, Iron, Ferritin, and Transferrin
    Time Frame
    "Through study completion, an average of 2 year"
    Title
    Upper Extremity Strength (in Newtons)
    Description
    Dynamometry to measure upper extremity (Grip and shoulder forward flexion) strength
    Time Frame
    "Through study completion, an average of 2 year"
    Title
    Lower Extremity Muscle Strength (in Newtons)
    Description
    Dynamometry to measure lower extremity (Knee extension) strength
    Time Frame
    "Through study completion, an average of 2 year"
    Title
    Skeletal Muscle Mass (kg)
    Description
    Bio-Impedance (BIA) to measure the skeletal muscle mass (kg)
    Time Frame
    "Through study completion, an average of 2 year"
    Title
    Muscle Fatigue
    Description
    Electromyographic (EMG) assessment of localised muscle fatigue
    Time Frame
    "Through study completion, an average of 2 year"
    Title
    Muscle Activation
    Description
    Electromyographic (EMG) assessment of muscle activity level
    Time Frame
    "through study completion, an average of 2 year"
    Title
    Gait Analysis
    Description
    3-Dimensional Motion Capture to assess gait quality
    Time Frame
    "Through study completion, an average of 2 year"
    Title
    Short Battery of Physical Performance (SBPP)
    Description
    A validated test for assessing physcial and functional capacity
    Time Frame
    "through study completion, an average of 2 year"
    Title
    Mitochondrial Function
    Description
    Near-infrared spectroscopy (NIRS) to investigate quality of oxidation in muscles
    Time Frame
    "through study completion, an average of 2 year"
    Title
    The 12-Item Short Form Health Survey (SF-12)
    Description
    A patient-rated questionnaire to assess the Quality of Life
    Time Frame
    "Through study completion, an average of 2 year"
    Title
    The Hospital Anxiety and Depression Scale (HADS)
    Description
    A patient-rated questionnaire to assess anxiety and Depression
    Time Frame
    "Through study completion, an average of 2 year"
    Title
    The Sarcopenia Quality of Life (SarQoL)
    Description
    A patient-rated questionnaire to assess Sarcopenia-specific quality of life
    Time Frame
    "through study completion, an average of 2 year"
    Title
    The Upper Extremity Functional Index (UEFI)
    Description
    A patient-rated questionnaire to assess Upper Extremity Function
    Time Frame
    "through study completion, an average of 2 year"
    Title
    The Lower Extremity Functional Index (UEFI)
    Description
    A patient-rated questionnaire to assess Lower Extremity Function
    Time Frame
    "through study completion, an average of 2 year"

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Professor Khaiyat
    Phone
    00441512913262
    Email
    alizado@hope.ac.uk
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mrs Smylie
    Phone
    00441512913996
    Email
    smylieg@hope.ac.uk

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    NK
    Links:
    URL
    https://www.isrctn.com/ISRCTN13325706
    Description
    ISRCTN
    URL
    https://www.hra.nhs.uk/planning-and-improving-research/application-summaries/research-summaries/impact-of-intravenous-iron-on-musculoskeletal-function-in-older-adults/
    Description
    NHS/HRA
    URL
    https://trialsearch.who.int/Trial2.aspx?TrialID=ISRCTN13325706
    Description
    WHO - International Trial Registry Platform

    Learn more about this trial

    Impact of Intravenous Iron on Musculoskeletal Function in Older Adults

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