About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patients already taking intravenous or oral iron
BMI > 40 kg/m²
Uncontrolled hypertension/ diabetes
Potential medication interactions
Trial design
Parallel
Treatments tested in this trial
Ferinject
DrugFerinject 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 MG
DrugActive Control Group (standard care excl. IV Iron): Oral Ferrous sulphate 200 mg three times daily.
Treatment groups
Trial outcomes
Primary outcomes
Muscle Quality Index (MQI)
Muscle strength relative to volume of the muscle mass generating the force
Secondary outcomes
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
Locations
Sponsors and contacts
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Liverpool Hope University
Lead sponsor
Liverpool University Hospitals NHS Foundation Trust
Collaborator
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