protocolSection identificationModule nctId: NCT06321887, orgStudyIdInfo id: 5155, briefTitle: EffiCacy and sAfEty of Low doSe orAl iRon for Anaemia in IBD, acronym: CAESAR, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-20, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2025-10-01, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Liverpool University Hospitals NHS Foundation Trust, class: OTHER_GOV, descriptionModule briefSummary: Iron deficiency anaemia (IDA) is common in inflammatory bowel disease (IBD). However, although iron is commonly prescribed, the amount of elemental iron needed to achieve clinical efficacy, and the optimal method of supplementation, are under debate. This pilot study aims to investigate the efficacy and safety of low dose and standard dose oral iron preparations for the treatment of IDA in patients with IBD., conditionsModule conditions: Inflammatory Bowel Disease, conditions: Iron Deficiency Anemia, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: This is an adaptive, open label study to compare the efficacy and tolerability of 8 weeks of low dose oral iron, in the treatment of iron deficiency anaemia in patients with inflammatory bowel disease (IBD)., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Ferrous fumarate syrup 2.5ml/70mg (22.5mg elemental iron), interventions name: Ferrous fumarate syrup 2.5ml/70mg(45mg elemental iron), interventions name: Ferrous fumarate syrup 2.5ml/70mg (90mg elemental iron), outcomesModule primaryOutcomes measure: Change in haemoglobin concentration from baseline to week 8., secondaryOutcomes measure: Assessment of iron stores at baseline and week 8, secondaryOutcomes measure: Assessment of faecal calprotectin at baseline and week 8, secondaryOutcomes measure: Assessment of IBD severity. For ulcerative colitis this will be done using simple colitis clinical activity index (SCCAI). Values calculated at week 0 and week 8., secondaryOutcomes measure: Assessment of IBD severity. For Crohn's disease (or IBD-unclassified) the Harvey Bradshaw Index (HBI) will be used. Values calculated at week 0 and week 8., secondaryOutcomes measure: Assessment of quality of life using the IBD-QUK score at baseline and week 8, secondaryOutcomes measure: Assessment of patient global assessment of symptom severity by visual analogue score at baseline and week 8., secondaryOutcomes measure: Assessment of fatigue at baseline and week 8 using IBD-F fatigue score, secondaryOutcomes measure: Assessment of possible drug-related side effects: nausea, diarrhoea, mood disturbance, sleep disturbance - will all be assessed at baseline and week 8., otherOutcomes measure: Experimental arm 1: Assessment of faecal metabolome composition at baseline and week 8, otherOutcomes measure: Experimental arm 2: Assessment of faecal microbiota composition at baseline and week 8, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 79 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Liverpool University Foundation NHS Trust, status: RECRUITING, city: Liverpool, country: United Kingdom, contacts name: S Subramanian, role: CONTACT, phone: 01517062000, email: RGT@liverpoolft.nhs.uk, contacts name: T Conley, role: CONTACT, phone: 01517062000, email: RGT@liverpoolft.nhs.uk, geoPoint lat: 53.41058, lon: -2.97794, hasResults: False