(duplicate) Oral haem to treat anaemia in patients with IBD
Research type
Research Study
Full title
The effectiveness and tolerability of GlobiFer (haem iron) capsules compared to ferrous sulphate tablets in inflammatory bowel disease: a randomised-controlled trial.
IRAS ID
30509
Sponsor organisation
Cruoguard Sweden AB - Cryoguard Pharma
Eudract number
2008-004277-17
ISRCTN Number
N/A
Research summary
Anaemia is very common in inflammatory bowel disease-IBD (which comprises ulcerative colitis and Crohn's disease) and is due to a combination of bleeding, inadequate dietary intake of iron and anaemia due to inflammation. Oral iron supplementation using standard "iron tablets" is poorly tolerated as these tablets cause GI side effects and there is evidence that iron in the gut may promote inflammation and make colitis worse. We propose to study the effectiveness, safety and tolerability of a novel form of iron supplementation (GlobiFer) which consists of iron complexed to a soluble form of haem (which is the main iron carrying protein in blood). The haem is derived from bovine blood and Globifer is in widespread use in Scandinavia but is not yet available in the UK. Globifer contains much less iron than standard iron tablets (ferrous sulphate-of plant origin) but because the latter consists of the natural animal (organic) product haem which should be absorbed much more efficiently than plant derived (inorganic) iron, we hypothesise that Globifer will be more effective at resolving anaemia and better tolerated than ferrous sulphate. Patients with inactive IBD who are anaemic and do not have a history of intolerance to oral iron are eligible for this study. They are randomly treated for 12 weeks with either ferrous sulphate or Globifer and outcomes in terms of effectiveness and side effects are assessed.
REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
09/H1211/74
Date of REC Opinion
7 Sep 2009
REC opinion
Favourable Opinion