Oxidative Stress and Inflammation Caused by Intravenous Iron in Crohn's Disease Patients With Iron Deficiency Anemia
NCT ID: NCT01823029
Last Updated: 2013-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
387 participants
INTERVENTIONAL
2012-11-30
2013-11-30
Brief Summary
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Detailed Description
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The anaemia in CD is caused by several factors, such as iron, folic acid or B12 deficiency, treatment with immunosuppressive drugs or sulfasalazine-induced hemolysis, and anemia of chronic disease, of which iron deficiency was one of the most important mechanisms. Additionally, erythropoietin(EPO) levels in chronic disease anemia are generally higher than in normal subjects.However, in CD anemic patients this EPO increase is inadequate in relation to the degree of anemia.Thus, in the treatment of iron deficiency anemia (IDA) in CD,EPO and iron supplementation are very common.Because intravenous(IV) iron is more effective and better tolerated than oral iron and is to be considered in patients with severe anemia (Hb\<10.0 g/dL), with intolerance or inadequate response to oral iron and/or those with active IBD. Intravenous iron administration is the route of choice when simultaneous treatment with erythropoiesis stimulat-ing agents (ESA) is considered.
But parenteral iron formulations have potential toxic effects such as triggering oxidative reactions and inflammatory reactions that may be very disadvantageous to CD patients. Free iron may provoke formation of free oxygen radicals. Although complex carbohydrate structures that cover free iron may alleviate this oxidative and inflammatory potential,it cannot be completely blocked. These suggest that parenteral iron could be a "double-edged sword" with the hematologic benefits (increase in hemoglobin \[Hb\]) on the one hand, and with the risk of enhancement of systemic inflammation and oxidative stress on the other.
Although the oxidative potential of intravenous iron (IVI) has been studied extensively,there have been no studies about the effects of parenteral iron therapy on oxidative stress and inflammatory markers in the CD population. In this study, we compared different types and schedules of iron compounds for their effects on serum inflammatory-oxidative stress indices.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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erythropoietin,injection of iron and enteral nutrition
The patients receive treatment of erythropoietin,injection of iron and enteral nutrition.
erythropoietin
enteral nutrition.
injection of iron
erythropoietin and enteral nutrition.
The patients receive treatment of erythropoietin and enteral nutrition.
erythropoietin
enteral nutrition.
Interventions
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erythropoietin
enteral nutrition.
injection of iron
Eligibility Criteria
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Inclusion Criteria
* Males and females ≥ 18 years old, including women who are not pregnant or lactating at the time of enrollment.
* Subjects should have a CDAI score \<150 at week 0
* Able to swallow tablets
* Are capable of providing written informed consent and obtained at the time of enrollment
* Willing to adhere to the study visit schedule and other protocol requirements.
* Subjects should have the hemoglobin： male patients\<130g/L，female patients\<120g/L.
Exclusion Criteria
* Needing orally administered corticosteroids for the treatment of other diseases. Inhaled or dermatologic preparations are acceptable.
* Previous or current use of infliximab.
* current use of prescription doses or chronic/frequent use of NSAIDs
* Treatment with narcotic pain medications. (Anti-diarrheal agents such as loperamide and diphenoxylate are permitted)
* History of pancreatitis, except for subjects with a known but removed cause(such as gallstone pancreatitis)
* History of abnormal liver function tests, including AST or ALT \>1.5 times upper limit of normal, alkaline phosphatase \>2 times upper limit of normal, total bilirubin \>2.5 mg/dL at screening (or within the previous 6 months, if known)
* History of malignancy
* Women who are pregnant or lactating at the time of enrollment, or who intend to be during the study period.
* Participation in other clinical trial within the past 6 months
18 Years
75 Years
ALL
No
Sponsors
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Ministry of Health, China
OTHER_GOV
Jinling Hospital, China
OTHER
Responsible Party
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Zhu Weiming
vice director of General surgery institute
Principal Investigators
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wei ming zhu, PhD,MD
Role: PRINCIPAL_INVESTIGATOR
General Surgery Institute,Jinling Hospital,Nanjing,Jiangsu,China
Locations
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General Surgery Institute,Jinling Hospital
Nanjing, Jiangsu, China
Countries
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References
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Kulnigg S, Gasche C. Systematic review: managing anaemia in Crohn's disease. Aliment Pharmacol Ther. 2006 Dec;24(11-12):1507-23. doi: 10.1111/j.1365-2036.2006.03146.x.
Bergamaschi G, Di Sabatino A, Albertini R, Ardizzone S, Biancheri P, Bonetti E, Cassinotti A, Cazzola P, Markopoulos K, Massari A, Rosti V, Porro GB, Corazza GR. Prevalence and pathogenesis of anemia in inflammatory bowel disease. Influence of anti-tumor necrosis factor-alpha treatment. Haematologica. 2010 Feb;95(2):199-205. doi: 10.3324/haematol.2009.009985. Epub 2009 Oct 8.
Goodhand JR, Kamperidis N, Rao A, Laskaratos F, McDermott A, Wahed M, Naik S, Croft NM, Lindsay JO, Sanderson IR, Rampton DS. Prevalence and management of anemia in children, adolescents, and adults with inflammatory bowel disease. Inflamm Bowel Dis. 2012 Mar;18(3):513-9. doi: 10.1002/ibd.21740. Epub 2011 May 20.
Reinisch W, Staun M, Bhandari S, Munoz M. State of the iron: how to diagnose and efficiently treat iron deficiency anemia in inflammatory bowel disease. J Crohns Colitis. 2013 Jul;7(6):429-40. doi: 10.1016/j.crohns.2012.07.031. Epub 2012 Aug 20.
Ott C, Liebold A, Takses A, Strauch UG, Obermeier F. High prevalence but insufficient treatment of iron-deficiency anemia in patients with inflammatory bowel disease: results of a population-based cohort. Gastroenterol Res Pract. 2012;2012:595970. doi: 10.1155/2012/595970. Epub 2012 Jul 30.
Noskova KK, Lishchinskaia AA, Parfenov AI, Kniazev OV, Varvanina GG, Drozdov VN. [Risk of development of clinical and pathogenetic features of anemia on the background of basic therapy of inflammatory bowel disease]. Eksp Klin Gastroenterol. 2011;(10):12-7. Russian.
Voegtlin M, Vavricka SR, Schoepfer AM, Straumann A, Voegtlin J, Rogler G, Ballabeni P, Pittet V, Buser A, Fried M, Beglinger C; Swiss IBD Cohort Study. Prevalence of anaemia in inflammatory bowel disease in Switzerland: a cross-sectional study in patients from private practices and university hospitals. J Crohns Colitis. 2010 Dec;4(6):642-8. doi: 10.1016/j.crohns.2010.07.008. Epub 2010 Aug 12.
Katsanos KH, Tatsioni A, Natsi D, Sigounas D, Christodoulou DK, Tsianos EV. Recombinant human erythropoietin in patients with inflammatory bowel disease and refractory anemia: a 15-year single center experience. J Crohns Colitis. 2012 Feb;6(1):56-61. doi: 10.1016/j.crohns.2011.07.004. Epub 2011 Aug 17.
Jian J, Yang Q, Dai J, Eckard J, Axelrod D, Smith J, Huang X. Effects of iron deficiency and iron overload on angiogenesis and oxidative stress-a potential dual role for iron in breast cancer. Free Radic Biol Med. 2011 Apr 1;50(7):841-7. doi: 10.1016/j.freeradbiomed.2010.12.028. Epub 2010 Dec 28.
Fishbane S, Kowalski EA. The comparative safety of intravenous iron dextran, iron saccharate, and sodium ferric gluconate. Semin Dial. 2000 Nov-Dec;13(6):381-4. doi: 10.1046/j.1525-139x.2000.00104.x.
Other Identifiers
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CD-AT1
Identifier Type: -
Identifier Source: org_study_id