Impact of Intravenous Iron on Musculoskeletal Function in Older Adults

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age60-85
SponsorLiverpool Hope University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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).

  • Ferrous Sulfate 200 MG

    Drug

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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Intravenous iron therapy groupExperimental treatment 1 intervention
Group B: Active Control GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Muscle Quality Index (MQI)

Muscle strength relative to volume of the muscle mass generating the force

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

Secondary outcomes

1

Health-history Questionnaire

Questionnaire to document participant health history

Time frame
Baseline
2

International Physical Activity Questionnaire-IPAQ)

Questionnaire to determine the level of physical activity

Time frame
Baseline
3

Blood Iron Profile

Blood analysis including Hemoglobin, Iron, Ferritin, and Transferrin

Time frame
"Through study completion, an average of 2 year"
4

Upper Extremity Strength (in Newtons)

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

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Liverpool Hope University

Lead sponsor

Liverpool University Hospitals NHS Foundation Trust

Collaborator

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