Impact of Intravenous Iron on Musculoskeletal Function in Older Adults

NCT05708170 | Not Yet Recruiting Phase 4

• 1 other identifier: LHU-FERIDA
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Iron Deficiency Anemia

Keywords

Iron Deficiency Anaemia; Skeletal Muscle Function; Musculoskeletal; Ageing

Outcome Measures

Primary Outcomes (1)

• Muscle Quality Index (MQI)

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

  "through study completion, an average of 2 year"

Secondary Outcomes (16)

• Health-history Questionnaire

  Baseline

• International Physical Activity Questionnaire-IPAQ)

  Baseline

• Blood Iron Profile

  "Through study completion, an average of 2 year"

• Upper Extremity Strength (in Newtons)

  "Through study completion, an average of 2 year"

• Lower Extremity Muscle Strength (in Newtons)

  "Through study completion, an average of 2 year"

Study Arms (2)

Intravenous iron therapy group

EXPERIMENTAL

This group will receive intravenous iron calculated based on body weight and level of anaemia (hemoglobin concentration), as per the iron therapy's SPC.

Drug: Ferinject

Active Control Group

ACTIVE COMPARATOR

This group will receive oral ferrous sulphate prescribed by their GP Randmisation: Simple randomisation/parallel assignment/single-blinded

Drug: Ferrous Sulfate 200 MG

Interventions

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).

Also known as: ferric carboxymaltose

Intravenous iron therapy group

Ferrous Sulfate 200 MG DRUG

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

Also known as: oral iron

Active Control Group

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Liverpool Hope University: lead
• Liverpool University Hospitals NHS Foundation Trust: collaborator

Related Links

• ISRCTN
• NHS/HRA
• WHO - International Trial Registry Platform

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

ferric carboxymaltose; ferrous sulfate; Iron

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Central Study Contacts

Professor Khaiyat

CONTACT

00441512913262; alizado@hope.ac.uk

Mrs Smylie

CONTACT

00441512913996; smylieg@hope.ac.uk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2022
• First Posted: February 1, 2023
• Study Start: January 1, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: February 1, 2023

Record last verified: 2022-08