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Impact of intravenous iron injections on musculoskeletal function in older adults

Impact of intravenous iron (Ferinject) on musculoskeletal function profiles in older adults with Iron Deficiency Anaemia (IDA)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN13325706
Enrollment
100
Registered
2021-01-28
Start date
2023-02-20
Completion date
Unknown
Last updated
2024-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron deficiency anaemia Circulatory System Iron deficiency anaemia

Interventions

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

Sponsors

Liverpool Hope University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Anaemia attributable to iron deficiency 2. Haemoglobin =60 to 85 years 5. Ambulatory individuals 6. BMI <=40 kg/m² 7. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Uncontrolled hypertension/ diabetes 2. Potential medication interactions 3. Hemochromatosis or iron storage disorders 4. Recent treatment with IV antibiotics or red blood cell transfusion 5. Dialysis dependent 6. History of malignancy 7. Pregnant or lactating women 8. Severe hepatic and renal dysfunction 9. Advanced cardiovascular disease and COPD 10. Advanced Neuromuscular disorder 11. Obvious cognitive disability and psychological illness 12. Current treatment with systemic steroids or any other substantive medication 13. Alcohol or any other drug abuse

Design outcomes

Primary

MeasureTime frame
Muscle Quality Index (MQI) determined based on muscle strength relative to quantity/volume of the muscle mass generating the force. Muscle strength will be measured using various dynamometers designed for upper and lower extremities and muscle volume will be assessed using the Bioimpedance technique at screening, week 4, week 12 and week 24

Secondary

MeasureTime frame
1. History & Health Screening measured at screening: 1.1. Health-history measured using the Health-history Questionnaire 1.2. Resting Heart Rate 1.3. Blood Pressure (mmHg) 1.4. Height (cm), weight (kg), BMI (kg/m²), Waist Circumference (cm) 1.5. Physical activity measured using the International Physical Activity Questionnaire 2. Biochemical parameters: Blood count, Serum Iron, Serum Ferritin and Transferrin levels measured using blood test at screening, week 4, week 12 and week 24 3. Muscular Function Profile including strength Measurements of the key muscle groups essential for daily activities and independence including hand-grip, shoulder, knee at screening, week 4, week 12 and week 24 4. Skeletal Muscle Mass measured using Segmental Bio-Impedance at screening, week 4, week 12 and week 24 5. Fatigability and Activation Pattern of key lower & upper extremity muscle groups measured using electromyography and gait analysis at screening, week 4, week 12 and week 24 6. Mitochondrial Function measured using near-infrared spectroscopy atscreening, week 4, week 12 and week 24 7. Health-related Quality of Life: SF-12 Health Survey, The single-item ‘Life Satisfaction and Personal Well-Being’ question at screening, week 4, week 12 and week 24 8. Anxiety and depression measured using the Hospital Anxiety and Depression Scale at screening, week 4, week 12 and week 24 9. Mood measured using the Profile of Mood States – Short Form at screening, week 4, week 12 and week 24

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026