A Pilot Study to Assess the Efficacy and Tolerability of Reduced Dose Oral Iron in the Treatment of Iron Deficiency Anaemia in Inflammatory Bowel Disease Patients.
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 79
Healthy Volunteers: t
View:
• Patient is willing to participate in the study and has signed the informed consent.
• Patients aged 18-80 years.
• Patients diagnosed with Crohn's disease or ulcerative colitis diagnosed by conventional clinical, radiological and histological criteria.
• Remission or active disease.
• Haemoglobin level 7-13 g/dL men, 7-12 g/dL women and ferritin \<30, normal B12 and folate (or ferritin \<100 but iron sats \<16 in the presence of inflammation defined as CRP\>5mg/L, faecal calprotectin\>250 microgram/g and presence of endoscopic inflammation).
Locations
Other Locations
United Kingdom
Liverpool University Foundation NHS Trust
RECRUITING
Liverpool
Contact Information
Primary
S Subramanian
RGT@liverpoolft.nhs.uk
01517062000
Backup
T Conley
RGT@liverpoolft.nhs.uk
01517062000
Time Frame
Start Date:2023-10-20
Estimated Completion Date:2025-10-01
Participants
Target number of participants:30
Treatments
Experimental: STAGE 1
The first stage shall recruit 10 patients and is used to assess the incidence of oral iron related toxicity.~Patients will be prescribed:~• Ferrous fumarate syrup 2.5ml/70mg (22.5mg elemental iron) daily for 8 weeks.~If patients experience toxicity (defined as symptoms not tolerated by the patient), the trial medication would be stopped and IV Iron treatment given.~If toxicity occurs in 2 or more patients where we have to stop treatment, we will continue to recruit 30 patients only to the Ferrous fumarate syrup 2.5ml/70mg (22.5mg elemental iron) daily for 8 weeks. If the toxicity is acceptable and the Hb improves, we will continue to recruit to 22.5mg oral iron/day.~If the toxicity is acceptable but there is no improvement in haemoglobin the next patients will be recruited to stage 2.
Experimental: STAGE 2
Ten subjects each will then be sequentially assigned to one of the following groups:~* Ferrous fumarate syrup 5ml/140mg (45mg elemental iron) daily for 8 weeks.~* Ferrous fumarate syrup 5ml/140mg twice daily (90mg elemental iron) for 8 weeks.~If 2 or more patients experience toxicity at Ferrous fumarate syrup 5ml/140mg (45mg elemental iron) or Ferrous fumarate syrup 5ml/140mg twice daily (90mg elemental iron) we will reduce the dose to the previous level of Ferrous fumarate syrup 2.5ml/70mg (22.5mg elemental iron) and continue to recruit.~30 patients shall be used to estimate the change in haemoglobin between baseline and the final analysis point.~If no dose reduction is required, only the last 20 patients shall be used to assess haemoglobin.~The overall endpoint is the haemoglobin level.
Who is this study for: Children 0 to <18 years of age with iron deficiency anemia due to NDD-CKD or with iron deficiency anemia who are intolerant or unresponsive to oral iron