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NCT Number: NCT05708170

Impact of Intravenous Iron on Musculoskeletal Function in Older Adults

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.

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Key information

Conditions

Iron Deficiency Anemia Anemia Anemia, Hypochromic Anemia, Iron-Deficiency Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ferinject

Drug

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).

Other names: ferric carboxymaltose

Ferrous Sulfate 200 MG

Drug

Active Control Group (standard care excl. IV Iron): Oral Ferrous sulphate 200 mg three times daily.

Other names: oral iron

Primary outcomes

  1. 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

Secondary outcomes

  1. Health-history Questionnaire

    Time frame: Baseline

    Questionnaire to document participant health history

  2. International Physical Activity Questionnaire-IPAQ)

    Time frame: Baseline

    Questionnaire to determine the level of physical activity

  3. Blood Iron Profile

    Time frame: "Through study completion, an average of 2 year"

    Blood analysis including Hemoglobin, Iron, Ferritin, and Transferrin

  4. Upper Extremity Strength (in Newtons)

    Time frame: "Through study completion, an average of 2 year"

    Dynamometry to measure upper extremity (Grip and shoulder forward flexion) strength

  5. Lower Extremity Muscle Strength (in Newtons)

    Time frame: "Through study completion, an average of 2 year"

    Dynamometry to measure lower extremity (Knee extension) strength

  6. Skeletal Muscle Mass (kg)

    Time frame: "Through study completion, an average of 2 year"

    Bio-Impedance (BIA) to measure the skeletal muscle mass (kg)

  7. Muscle Fatigue

    Time frame: "Through study completion, an average of 2 year"

    Electromyographic (EMG) assessment of localised muscle fatigue

  8. Muscle Activation

    Time frame: "through study completion, an average of 2 year"

    Electromyographic (EMG) assessment of muscle activity level

  9. Gait Analysis

    Time frame: "Through study completion, an average of 2 year"

    3-Dimensional Motion Capture to assess gait quality

  10. Short Battery of Physical Performance (SBPP)

    Time frame: "through study completion, an average of 2 year"

    A validated test for assessing physcial and functional capacity

  11. Mitochondrial Function

    Time frame: "through study completion, an average of 2 year"

    Near-infrared spectroscopy (NIRS) to investigate quality of oxidation in muscles

  12. The 12-Item Short Form Health Survey (SF-12)

    Time frame: "Through study completion, an average of 2 year"

    A patient-rated questionnaire to assess the Quality of Life

  13. The Hospital Anxiety and Depression Scale (HADS)

    Time frame: "Through study completion, an average of 2 year"

    A patient-rated questionnaire to assess anxiety and Depression

  14. The Sarcopenia Quality of Life (SarQoL)

    Time frame: "through study completion, an average of 2 year"

    A patient-rated questionnaire to assess Sarcopenia-specific quality of life

  15. The Upper Extremity Functional Index (UEFI)

    Time frame: "through study completion, an average of 2 year"

    A patient-rated questionnaire to assess Upper Extremity Function

  16. The Lower Extremity Functional Index (UEFI)

    Time frame: "through study completion, an average of 2 year"

    A patient-rated questionnaire to assess Lower Extremity Function

Study contacts

Contact information is provided by the study sponsor or research team.

Mrs Smylie

CONTACT

[email protected]

00441512913996

Professor Khaiyat

CONTACT

[email protected]

00441512913262

Sponsors and collaborators

Lead sponsor

Liverpool Hope University

Other

Collaborators

  • Liverpool University Hospitals NHS Foundation Trust

Registry information

Official study title

Impact of Intravenous Iron (Ferinject) on Musculoskeletal Function Profiles in Older Adults With Iron Deficiency Anaemia (IDA)

Acronym: FERIDA

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Feb 1, 2023
Registry last updated
Feb 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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