Oxidative Stress and Inflammation Caused by Intravenous Iron in Crohn's Disease Patients With Iron Deficiency Anemia

NCT01823029 | Completed

• 1 other identifier: CD-AT1
• Study Type: interventional
• Target: 387
• Locations: 1 country
• Sites: 1

Brief Summary

Extra iron may not be necessary in the treatment of iron deficiency anemia in Crohn's Disease;Oxidative Stress and Inflammation may be Caused by Intravenous Iron in Crohn's Disease Patients With Iron Deficiency Anemia.

Conditions

Crohn's Disease

Keywords

Crohn's Disease; intravenous iron; iron deficiency anaemia; Oxidative Stress; inflammation

Outcome Measures

Primary Outcomes (1)

• haemoglobin raise to norm or not.

  at 0 week, the first week, the second week, the third week, the fourth week

Secondary Outcomes (4)

• The change of haematological inflammation marker(CRP,ESR,IL-10,IL-6,TNF-ａ,IL-1β)

  at 0 week, the first week, the second week, the third week, the fourth week

• The change of haematological oxidative stress indicators(SOD,GSH-px and MDA)

  at 0 week, the first week, the second week, the third week, the fourth week

• The change of patients'IBDQ and CDAI.

  at 0 week and the fourth week

• relapse of anaemia

  12 weeks after treatment

Study Arms (2)

erythropoietin,injection of iron and enteral nutrition

EXPERIMENTAL

The patients receive treatment of erythropoietin,injection of iron and enteral nutrition.

Drug: erythropoietin; Drug: enteral nutrition.; Drug: injection of iron

erythropoietin and enteral nutrition.

EXPERIMENTAL

The patients receive treatment of erythropoietin and enteral nutrition.

Drug: erythropoietin; Drug: enteral nutrition.

Interventions

erythropoietin DRUG

erythropoietin and enteral nutrition.; erythropoietin,injection of iron and enteral nutrition

enteral nutrition. DRUG

erythropoietin and enteral nutrition.; erythropoietin,injection of iron and enteral nutrition

injection of iron DRUG

erythropoietin,injection of iron and enteral nutrition

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects should have a definitive diagnosis of Crohn's disease, based on WHO 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.

You may not qualify if:

• Bacterial,viral or other microbial infection(including HIV)
• 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

Sponsors & Collaborators

• Jinling Hospital, China: lead
• Ministry of Health, China: collaborator

Study Sites (1)

General Surgery Institute,Jinling Hospital

Nanjing, Jiangsu, 210000, China

Location

Related Publications (10)

• 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.

  PMID: 17206940 BACKGROUND

• 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.

  PMID: 19815838 BACKGROUND

• 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.

  PMID: 21604328 BACKGROUND

• 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.

  PMID: 22917870 BACKGROUND

• 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.

  PMID: 22899905 BACKGROUND

• 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.

  PMID: 22629693 BACKGROUND

• 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.

  PMID: 21122574 BACKGROUND

• 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.

  PMID: 22261528 BACKGROUND

• 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.

  PMID: 21193031 BACKGROUND

• 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.

  PMID: 11130261 BACKGROUND

MeSH Terms

Conditions

Crohn Disease; Anemia, Iron-Deficiency; Inflammation

Interventions

Erythropoietin; Enteral Nutrition

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Feeding Methods; Therapeutics; Nutritional Support; Nutrition Therapy

Study Officials

• wei ming zhu, PhD,MD

  General Surgery Institute,Jinling Hospital,Nanjing,Jiangsu,China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: vice director of General surgery institute

Study Record Dates

• First Submitted: March 25, 2013
• First Posted: April 4, 2013
• Study Start: November 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: November 1, 2013
• Last Updated: November 27, 2013

Record last verified: 2013-11

Locations

CN (1)