Iron deficiency anaemia Haematological Disorders Iron deficiency anaemia
Conditions
Interventions
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 balan
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 t
Sponsors
University of Aberdeen
NHS Grampian
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: 1. Active GI cancers 2. Active (unhealed) peptic ulcer disease 3. No ferritin level performed prior to commencing oral iron 3. Bleeding disorders (including being on oral anticoagulants; antiplatelet agents are permitted) 4. Weight loss of >5Kg in the last 3 months (as a possible marker of occult cancer) 5. Estimated GFR of <30ml/min/1.73m2 by CKD-EPI equation 6. Symptomatic chronic heart failure (defined according to the European Society of Cardiology guidelines; note asymptomatic left ventricular systolic dysfunction is not classed as heart failure) 7. Terminal illness (with life expectancy less than 3 months as deemed by the local investigator) 8. Severe cognitive impairment precluding written informed consent 9. Unable to mobilise without human assistance (walking aids are allowed) 10. Previous reaction to intravenous iron 11. Currently participating in, or within 30 days of completion of, another clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Scotland, United Kingdom
Contacts
Public ContactPhyo;Miles Myint;Witham
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Outcome results
None listed