Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06321887
Status:
RECRUITING
Last Update Posted:
2024-03-20
First Post:
2024-02-14
Brief Title:
EffiCacy and sAfEty of Low doSe orAl iRon for Anaemia in IBD
Sponsor:
Liverpool University Hospitals NHS Foundation Trust
Organization:
Liverpool University Hospitals NHS Foundation Trust
Study Overview
Official Title:
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
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAESAR
Brief 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
Detailed Description:
BACKGROUND
Anaemia particularly iron-deficiency anaemia is a common complication of inflammatory bowel disease IBD The prevalence of anaemia 6-74 and iron deficiency 36-90 varies widely among reported studies The predominant cause of iron deficiency in IBD is intestinal blood loss but other factors such as malabsorption and reduced intake may also play a role Thus the need for iron supplementation is an often encountered clinical problem in IBD Although iron is commonly prescribed the amount of elemental iron needed to achieve clinical efficacy and the optimal method of supplementation are under debate As intravenous IV iron supplementation has become safer calls for increased utilization have appeared However there are significant cost implications to using IV iron On average a 1-month supply of oral ferrous sulfate costs 12 in comparison with approximately 600-700 for a treatment cycle of IV iron sucrose excluding the cost of IV administration
Overall the comparative studies of IV vs oral iron do not demonstrate a significant difference in haemoglobin repletion favouring IV iron therapy Haemoglobin concentrations were similar at the end of treatment in all studies A single study suggested a superiority for IV iron with a haemoglobin increase greater than 2 gdl in 47 of the patients on oral iron compared with 66 on IV iron P 007 However this could be accounted for by a high withdrawal rate 24 in the oral iron group In the largest comparative study of 196 subjects median haemoglobin improved similarly from 87 to 123 gdl in the IV group and from 91 to 121 gdl in the ferrous sulfate group P 070 Thus intravenous iron appears no more effective than oral iron in repletion of iron status as the rate-limiting step appears to be synthesis of red cells which is not accelerated by IV iron delivery
The main reason behind the preference of IV iron over oral iron is based on the concern that oral iron may exacerbate IBD An often-cited study investigating whether oral iron worsens IBD in comparison with IV iron assessed disease activity in 19 IBD patients 11 with CD and 8 with UC randomized to either oral ferrous fumarate or IV iron sucrose over a 14-day period Although the authors argued that disease activity was worsened by oral iron therapy their use of numerous unconventional assessments weakens this conclusion The trial was done as a crossover study with a minimum 6-week washout period so the previous drug therapy may have affected the results The number of subjects with IBD was small N 19 The authors created a synthesized overall disease activity score by combining UC and CD scales and also reported on subscales within activity indexes to identify significant differences When the two groups were compared however there was no statistically significant difference in the overall synthesized disease activity score
Another factor associated with intolerance of oral iron may be related to the dose of elemental iron administered In order to maintain iron balance adult men need to absorb 1-15 mgd menstruating women need 1-3 mgd and pregnant women need approximately 4-5 mgd Based on this the recommended daily allowance of elemental iron is about 8 mg in adult men and postmenopausal women 18 mg in premenopausal women and 27 mg in pregnant women However most studies investigating the efficacy of oral iron have used a typical dose of 150-200mgd of elemental iron 10-20 fold in excess of the recommended daily allowance Because of the 20 incidence level of intolerance at these conventional doses of elemental iron recent studies have investigated the efficacy and side effects associated with low-dose oral iron supplementation A study in the elderly age 80 randomised 90 patients with iron-deficiency anaemia to 15 50 or 150 mg of daily oral elemental iron over 2 months All three dosage groups experienced a similar statistically significant increase in haemoglobin after 2 months These studies have not been done in IBD
This pilot study aims to investigate the efficacy and safety of low dose and standard dose oral iron preparations
HYPOTHESIS
Low dose oral iron is effective and safe in the treatment of iron deficiency anaemia in inflammatory bowel disease
Anaemia particularly iron-deficiency anaemia is a common complication of inflammatory bowel disease IBD The prevalence of anaemia 6-74 and iron deficiency 36-90 varies widely among reported studies The predominant cause of iron deficiency in IBD is intestinal blood loss but other factors such as malabsorption and reduced intake may also play a role Thus the need for iron supplementation is an often encountered clinical problem in IBD Although iron is commonly prescribed the amount of elemental iron needed to achieve clinical efficacy and the optimal method of supplementation are under debate As intravenous IV iron supplementation has become safer calls for increased utilization have appeared However there are significant cost implications to using IV iron On average a 1-month supply of oral ferrous sulfate costs 12 in comparison with approximately 600-700 for a treatment cycle of IV iron sucrose excluding the cost of IV administration
Overall the comparative studies of IV vs oral iron do not demonstrate a significant difference in haemoglobin repletion favouring IV iron therapy Haemoglobin concentrations were similar at the end of treatment in all studies A single study suggested a superiority for IV iron with a haemoglobin increase greater than 2 gdl in 47 of the patients on oral iron compared with 66 on IV iron P 007 However this could be accounted for by a high withdrawal rate 24 in the oral iron group In the largest comparative study of 196 subjects median haemoglobin improved similarly from 87 to 123 gdl in the IV group and from 91 to 121 gdl in the ferrous sulfate group P 070 Thus intravenous iron appears no more effective than oral iron in repletion of iron status as the rate-limiting step appears to be synthesis of red cells which is not accelerated by IV iron delivery
The main reason behind the preference of IV iron over oral iron is based on the concern that oral iron may exacerbate IBD An often-cited study investigating whether oral iron worsens IBD in comparison with IV iron assessed disease activity in 19 IBD patients 11 with CD and 8 with UC randomized to either oral ferrous fumarate or IV iron sucrose over a 14-day period Although the authors argued that disease activity was worsened by oral iron therapy their use of numerous unconventional assessments weakens this conclusion The trial was done as a crossover study with a minimum 6-week washout period so the previous drug therapy may have affected the results The number of subjects with IBD was small N 19 The authors created a synthesized overall disease activity score by combining UC and CD scales and also reported on subscales within activity indexes to identify significant differences When the two groups were compared however there was no statistically significant difference in the overall synthesized disease activity score
Another factor associated with intolerance of oral iron may be related to the dose of elemental iron administered In order to maintain iron balance adult men need to absorb 1-15 mgd menstruating women need 1-3 mgd and pregnant women need approximately 4-5 mgd Based on this the recommended daily allowance of elemental iron is about 8 mg in adult men and postmenopausal women 18 mg in premenopausal women and 27 mg in pregnant women However most studies investigating the efficacy of oral iron have used a typical dose of 150-200mgd of elemental iron 10-20 fold in excess of the recommended daily allowance Because of the 20 incidence level of intolerance at these conventional doses of elemental iron recent studies have investigated the efficacy and side effects associated with low-dose oral iron supplementation A study in the elderly age 80 randomised 90 patients with iron-deficiency anaemia to 15 50 or 150 mg of daily oral elemental iron over 2 months All three dosage groups experienced a similar statistically significant increase in haemoglobin after 2 months These studies have not been done in IBD
This pilot study aims to investigate the efficacy and safety of low dose and standard dose oral iron preparations
HYPOTHESIS
Low dose oral iron is effective and safe in the treatment of iron deficiency anaemia in inflammatory bowel disease
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None