[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100493670":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":35,"locations":34,"responsibleParty":45,"collaborators":47,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":53,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":34,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":76,"whyStopped":34,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":34},{"fullName":5,"class":6},"Liverpool Hope University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Drug: Ferinject",{"label":15,"type":16,"description":17,"interventionNames":18},"Active Control Group","ACTIVE_COMPARATOR","This group will receive oral ferrous sulphate prescribed by their GP Randmisation: Simple randomisation\u002Fparallel assignment\u002Fsingle-blinded",[19],"Drug: Ferrous Sulfate 200 MG",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Ferinject","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:\n\n* 15 mg iron\u002Fkg body weight (for administration by intravenous injection) or 20 mg iron\u002Fkg body weight (for administration by intravenous infusion)\n* 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).",[9],[27],"ferric carboxymaltose",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Ferrous Sulfate 200 MG","Active Control Group (standard care excl. IV Iron): Oral Ferrous sulphate 200 mg three times daily.",[15],[33],"oral iron",null,[36,41],{"name":37,"role":38,"phone":39,"phoneExt":34,"email":40},"Professor Khaiyat","CONTACT","00441512913262","alizado@hope.ac.uk",{"name":42,"role":38,"phone":43,"phoneExt":34,"email":44},"Mrs Smylie","00441512913996","smylieg@hope.ac.uk",{"type":46,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR",[48],{"name":49,"class":50},"Liverpool University Hospitals NHS Foundation Trust","OTHER_GOV","100493670","phase-4-impact-of-intravenous-iron-on-musculoskeletal-function-in-older-adults-100493670",false,"NCT05708170","Impact of Intravenous Iron on Musculoskeletal Function in Older Adults","Impact of Intravenous Iron (Ferinject) on Musculoskeletal Function Profiles in Older Adults With Iron Deficiency Anaemia (IDA)","FERIDA","Inclusion Criteria:\n\n* Anaemia attributable to iron deficiency\n* Haemoglobin \\\u003C 120 g\u002FL in women, Hb \\\u003C 130 g\u002FL in men\n* Ferritin ≤100 ng\u002FmL or ≤300 ng\u002FmL if transferrin saturation (TSAT) ≤30%\n* Age ≥ 60 to 85 years\n* Ambulatory individuals\n* Written informed consent\n\nExclusion Criteria:\n\n* Patients already taking intravenous or oral iron\n* BMI \\> 40 kg\u002Fm²\n* Uncontrolled hypertension\u002F diabetes\n* Potential medication interactions\n* Hemochromatosis or iron storage disorders\n* Recent treatment with IV antibiotics or red blood cell transfusion\n* Dialysis dependent\n* History of malignancy\n* Pregnant or lactating women\n* Severe hepatic and renal dysfunction\n* Advanced cardiovascular disease and COPD\n* Advanced Neuromuscular disorder\n* Obvious cognitive disability and psychological illness\n* Current treatment with systemic steroids or any other substantive medication\n* Alcohol or any other drug abuse","ALL","60 Years","85 Years",{"count":63,"type":64},100,"ESTIMATED","INTERVENTIONAL",[67],"PHASE4","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.\n\nIn 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.",[70],"Iron Deficiency Anemia",[72,73,74,75],"Iron Deficiency Anaemia","Skeletal Muscle Function","Musculoskeletal","Ageing","NOT_YET_RECRUITING","2023-01-23",{"date":79,"type":80},"2023-02-01","ACTUAL",{"date":82,"type":64},"2023-01",{"date":84,"type":64},"2027-01",{"name":5,"class":6}]