Oral iron, intravenous iron or discontinuation of therapy for older adults with treatment unresponsive iron deficiency anaemia

INTERVENTION: Participants will be randomised on a 1:1:1 allocation ratio via a web‐based randomisation system run by a third party. A minimisation algorithm with a small random element will be used to ensure balance across recruitment centres and key baseline measures. Randomisation will be stratified by site, and further balanced using minimisation. Haemoglobin after minimum 8 weeks of oral iron (>=100g/L vs <100g/L), ferritin prior to commencement of oral iron (>=50ug/L vs <50ug/L) and six minute walk distance (>=300m vs <300m) will be the minimisation variables. Participants are randomised to either: 1. Continue the iron tablets they are already taking 2. Stop their iron tablets and receive intravenous iron on one or two occasions 3. Stop their iron tablets and have no further iron Before the start and 3 months later, participants are asked a series of questions about how tired or breathless they feel; undergo tests to see how quickly they can walk and other measures of fitness and balance; complete questionnaires about how well they are taking their medicines, their quality of life, and what contact they have had recently with health services. The trialists will compare how easy it is to find eligible people through GP practices, adverts and hospital clinics, and will measure haemoglobin in the blood (a measure of anaemia) at the start and 3 months later. CONDITION: Iron deficiency anaemia ; Haematological Disorders ; Iron deficiency anaemia PRIMARY OUTCOME: Co‐primary outcomes, measured from recruitment records at the end of recruitment:; 1. The rate of randomisation per month across the pilot sites; 2. The proportion recruited from each route of recruitment SECONDARY OUTCOME: Measured between baseline and 3 months:; 1. Hemoglobin levels, measured by blood sample at baseline and 3 months; 2. Eligible patients per site, measured from recruitment records at end of recruitment; 3. Proportion of eligible patients agreeing to take part and passing screening, measured from recruitment records at end of recruitment; 4. Feasibility of collecting primary (physical functioning and health‐related and general quality of life) and secondary outcomes for main trial:; 4.1. Six minute walk distance, measured by walk test at baseline and 3 months; 4.2. Short physical performance battery (SPPB), measured at baseline and 3 months; 4.3. Health‐related quality of life, measured using EQ‐5D, 15D; 4.4. Anemia‐related symptoms (e.g. breathlessness, tiredness, fatigue), measured by symptom questionnaire at baseline and 3 months; 4.5. Healthcare useincluding use of blood transfusions and hospitalisation, measured by questionnaire at 3 months; 4.6. Mortality, measured by death certificate records at 3 months; 5. Dropout and crossover rate, measured from recruitment and follow up records at 3 months ; 6. Side effects and adverse events (GI symptoms, headache, dizziness, rash), measured from case record form at 3 months; 7. Functional limitation, measured using six‐minute walk (<400m) or short physical performance battery( =10) at baseline and 3 months; 8. Fatigue, measured using validated Fatigue Severity Scale at baseline and 3 months INCLUSION CRITERIA: 1. Age 65 years or over 2. Haemoglobin of >=85g/L and <=110g/L prior to commencing oral iron 3. Ferritin <100µg/L prior to commencing oral iron 4. Currently taking oral iron at any dose with a minimum of 8 weeks therapy 5. Insufficient response to oral iron therapy (sufficient response defined as improvement in Hb of 20g/L after a minimum of 8 weeks of oral iron therapy) 6. Relevant investigations (including upper and lower GI endoscopies) either already conducted, offered but declined by the patient, or deemed not appropriate by the treating clinician