Impact of Intravenous Iron on Musculoskeletal Function in Older Adults

• Status: Not yet recruiting
• Trial end date: 2027-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Liverpool Hope University
• Collaborator: Liverpool University Hospitals NHS Foundation Trust

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