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

Phase 1

• Conditions: Iron deficiency anaemia in inflammatory bowel disease; MedDRA version: 20.0Level: LLTClassification code 10002062Term: Anaemia iron deficiencySystem Organ Class: 100000004851; MedDRA version: 20.1Level: PTClassification code 10021972Term: Inflammatory bowel diseaseSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2018-002982-20-GB
• Lead Sponsor: Royal Liverpool University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-05
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 30

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 <100 ug/l, normal B12 and folate, ferritin <200 ug/l but iron saturation <18% in the presence of anaemia and raised inflammtory markers

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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?<br>Is a reduced dose oral iron safe and effective in correcting anaemia associated with IBD?;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

Secondary Outcome Measures

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