A preliminary study to assess if low dose iron is safe and effective in patients with inflammatory bowel disease

A Pilot Study to assess the efficacy and safety of reduced dose oral iron in the treatment of iron deficiency anaemia in inflammatory bowel disease patients - Efficacy and safety of low dose oral iron for anaemia in IBD (CAESAR)

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-002982-20-GB

Enrollment

Registered

2019-12-05

Start date

2020-01-29

Completion date

Unknown

Last updated

2025-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron deficiency anaemia in inflammatory bowel disease MedDRA version: 20.0 Level: LLT Classification code 10002062 Term: Anaemia iron deficiency System Organ Class: 100000004851 MedDRA version: 20.1 Level: PT Classification code 10021972 Term: Inflammatory bowel disease System Organ Class: 10017947 - Gastrointestinal disorders

Interventions

Trade Name: Ferrous Fumarate Syrup Product Name: Ferrous Fumarate Syrup Product Code: Ferrous fumarate syrup Pharmaceutical Form: Syrup INN or Proposed INN: Ferrous fumarate CAS Number: 141-01-5 Curre

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (i) Patient is willing to participate in the study and has signed the informed consent (ii) Patients aged 18-80 with Crohn’s disease or ulcerative colitis diagnosed by conventional clinical, radiological and histological criteria. (ii) Haemoglobin level 7-13 g/dL men, 7-12 g/dL women and evidence of iron deficiency as defined by ferritin =65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: (i) Patients under 18 or unable to give informed consent. (ii) Patients with advanced liver disease. (iii) Patients with advanced renal disease. (iv) Previous intolerance of oral iron. (v) Patients with severe cardiovascular disease defined as previous unstable angina and or previous MI without intervention. (vi) Participation in other trials in the last 3 months. (vii) Serious inter-current infection or other clinically important active disease (including renal and hepatic disease) (viii) Pregnant, post partum (<3months) or breast feeding females (ix) Erythropoetin therapy. (x) Recent blood transfusion within 30 days. (xi) Recent iron infusion within 30 days.

Design outcomes

Primary

Measure	Time frame
Primary end point(s): This is a pilot study. The primary outcome is to examine the feasibility of a larger randomised trial. Estimates of the variability of hamoglobin will be obtained which will inform the design of a future trial.;Timepoint(s) of evaluation of this end point: Evaluable at the end of study;Main Objective: To determine the feasibility of doing a larger clinical trial;Secondary Objective: Does low dose oral iron affect the stool bacterial population in IBD patients? Is a reduced dose oral iron safe and effective in correcting anaemia associated with IBD?	—

Measure

Time frame

Primary end point(s): This is a pilot study. The primary outcome is to examine the feasibility of a larger randomised trial. Estimates of the variability of hamoglobin will be obtained which will inform the design of a future trial.;Timepoint(s) of evaluation of this end point: Evaluable at the end of study;Main Objective: To determine the feasibility of doing a larger clinical trial;Secondary Objective: Does low dose oral iron affect the stool bacterial population in IBD patients? Is a reduced dose oral iron safe and effective in correcting anaemia associated with IBD?

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Secondary

Measure	Time frame
Secondary end point(s): (i) Improvement in haemoglobin concentration from baseline to end of study and at week 4. (ii) Assessment of iron stores at weeks 4 and 8. (iii) Assessment of faecal calprotectin at weeks 4 and 8. (iv) Assessment of disease severity using standardised questionnaires at weeks 4 and 8. (v) Quality of life at weeks 4 and 8. (vi) Patient global assessment of symptom severity by visual analogue score at weeks 4 and 8 or early withdrawal. (vii) Patient assessment of fatigue at weeks 4 and 8 using IBD-F fatigue score. (viii) Patient assessment of possible drug-related side effects: nausea, diarrhoea, mood disturbance, sleep disturbance – will all be assessed at all visits. (ix) Changes in stool bacterial composition from baseline to end of study ;Timepoint(s) of evaluation of this end point: At defined time points and all analyses will be conducted as specified in the protocol	—

Measure

Time frame

Secondary end point(s): (i) Improvement in haemoglobin concentration from baseline to end of study and at week 4. (ii) Assessment of iron stores at weeks 4 and 8. (iii) Assessment of faecal calprotectin at weeks 4 and 8. (iv) Assessment of disease severity using standardised questionnaires at weeks 4 and 8. (v) Quality of life at weeks 4 and 8. (vi) Patient global assessment of symptom severity by visual analogue score at weeks 4 and 8 or early withdrawal. (vii) Patient assessment of fatigue at weeks 4 and 8 using IBD-F fatigue score. (viii) Patient assessment of possible drug-related side effects: nausea, diarrhoea, mood disturbance, sleep disturbance – will all be assessed at all visits. (ix) Changes in stool bacterial composition from baseline to end of study ;Timepoint(s) of evaluation of this end point: At defined time points and all analyses will be conducted as specified in the protocol

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Countries

United Kingdom

Contacts

Public ContactRogers

Royal Liverpool University Hospital

Heather.Rogers@rlbuht.nhs.uk01517063702

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026