Anemia in Inflammatory Bowel Disease

NCT02760940 | Unknown Phase 4 DMC

• 1 other identifier: CAAE:0200.0.200.000-10
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

Anemia is a clinical manifestation, which is commonly observed in patients with inflammatory bowel disease, and it accounts for significant loss in the quality of life of these patients. The aim of the current study is to assess the effect of orally administered iron treatment, as well as its response predictors in patients with inflammatory bowel disease who are in remission and present anemia. The study will recruit 100 patients with Crohn's disease (CD) and 100 patients with ulcerative colitis (UC) diagnosed and regularly monitored in the Inflammatory Bowel Disease Center at the University Hospital of the Federal University of Juiz de Fora, for clinical, hematological, biochemical and immunological assessment. Blood samples will be collected (10 ml) and the following tests will be performed in all the anemia patients (in remission) at the beginning of the treatment and 8 weeks later: complete blood count, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), erythrocyte sedimentation rate (ESR) , transferrin saturation index, ferritin, serum iron, hepcidin, quantitative C-reactive protein (CRP), interleukin-6 (IL-6)) and fecal calprotectin. In addition, quality of life, anxiety and depression and fatigue questionnaires will be applied to the patients (IBDQ, HAD and Chalder). The World Health Organization (WHO) criteria will be used to diagnose anemia, therefore, hemoglobin lower than 12 g/dl for women and 13g/dl for men will be considered anemia; hemoglobin lower than 10 g/dl will be considered severe anemia. Patients with mild and moderate anemia in remission will be initially treated with oral iron (oral liposomal iron) and the occurrence of possible symptoms related to oral iron intolerance will be assessed, as well as the patients' disease activity level and quality of life. The patients in follow-up will be subjected to new laboratory tests after the eighth oral iron treatment week. The results of the current study are expected to help assessing the oral iron efficacy and response predictors, as well as the side effects of the treatment and its impact on the quality of life of patients.

Conditions

Anemia; Bowel Diseases, Inflammatory

Keywords

Inflammatory bowel diseases; Anemia; Crohn's disease; Ulcerative colitis; Oral iron; Quality of life

Outcome Measures

Primary Outcomes (1)

• Hemoglobin level improvement

  The supplementation will be performed in patients with mild to moderate anemia, since patients with severe anemia usually require more aggressive treatments. The replenishment will be provided at no cost to the patients at the dose of 2 (two) iron liposomal iron tablet per day (equivalent to 28 mg of iron). The patients will be instructed to take one tablet of 14 mg twice a day. They will be monitored by telephone in weekly interval periods throughout the intervention phase in order to optimize their adhesion to the treatment and verify the occurrence of possible side effects and the improvement in hemoglobin level.

  8 weeks

Secondary Outcomes (4)

• Improvement of quality of life

  8 weeks

• Improvement of fatigue

  8 weeks

• Activation of inflammation

  8 weeks

• Improvement of anxiety and depression

  8 weeks

Study Arms (1)

Oral liposomal iron treatment

EXPERIMENTAL

Oral liposomal iron - 28 mg per day over 8 weeks

Drug: oral liposomal iron

Interventions

oral liposomal iron DRUG

After screening, anemic patients will be treated during 8 weeks with 28mg of oral liposomal iron per day and then the investigators will report data assessing the tolerability and efficacy of oral liposomal iron treatment in these patients.

Also known as: ferric pyrophosphate

Oral liposomal iron treatment

Eligibility Criteria

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

You may qualify if:

• Diagnosis of inflammatory bowel disease (Crohn's disease or ulcerative colitis ) in remission
• Anemia

You may not qualify if:

• Pre-existing liver disease
• Kidney failure
• Clinically significant pulmonary disease
• Systemic infection
• Pregnancy
• Current history of any type of malignancy (except skin)
• Gastrectomy
• Total colectomy or extensive intestinal resection (\> 100 cm )
• Inflammatory bowel disease activity
• Severe anemia.

Sponsors & Collaborators

• Federal University of Juiz de Fora: lead

Related Publications (13)

• Bager P, Befrits R, Wikman O, Lindgren S, Moum B, Hjortswang H, Dahlerup JF. The prevalence of anemia and iron deficiency in IBD outpatients in Scandinavia. Scand J Gastroenterol. 2011 Mar;46(3):304-9. doi: 10.3109/00365521.2010.533382. Epub 2010 Nov 15.

  PMID: 21073374 BACKGROUND

• Befrits R, Wikman O, Blomquist L, Hjortswang H, Hammarlund P, Bajor A, Klintman D, Blom H. Anemia and iron deficiency in inflammatory bowel disease: an open, prospective, observational study on diagnosis, treatment with ferric carboxymaltose and quality of life. Scand J Gastroenterol. 2013 Sep;48(9):1027-32. doi: 10.3109/00365521.2013.819442. Epub 2013 Jul 29.

  PMID: 23889159 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

• Gasche C, Ahmad T, Tulassay Z, Baumgart DC, Bokemeyer B, Buning C, Howaldt S, Stallmach A; AEGIS Study Group. Ferric maltol is effective in correcting iron deficiency anemia in patients with inflammatory bowel disease: results from a phase-3 clinical trial program. Inflamm Bowel Dis. 2015 Mar;21(3):579-88. doi: 10.1097/MIB.0000000000000314.

  PMID: 25545376 BACKGROUND

• Iqbal T, Stein J, Sharma N, Kulnigg-Dabsch S, Vel S, Gasche C. Clinical significance of C-reactive protein levels in predicting responsiveness to iron therapy in patients with inflammatory bowel disease and iron deficiency anemia. Dig Dis Sci. 2015 May;60(5):1375-81. doi: 10.1007/s10620-014-3460-4. Epub 2014 Dec 12.

  PMID: 25501922 BACKGROUND

• Kaitha S, Bashir M, Ali T. Iron deficiency anemia in inflammatory bowel disease. World J Gastrointest Pathophysiol. 2015 Aug 15;6(3):62-72. doi: 10.4291/wjgp.v6.i3.62.

  PMID: 26301120 BACKGROUND

• Nemeth E, Rivera S, Gabayan V, Keller C, Taudorf S, Pedersen BK, Ganz T. IL-6 mediates hypoferremia of inflammation by inducing the synthesis of the iron regulatory hormone hepcidin. J Clin Invest. 2004 May;113(9):1271-6. doi: 10.1172/JCI20945.

  PMID: 15124018 BACKGROUND

• Nielsen OH, Ainsworth M, Coskun M, Weiss G. Management of Iron-Deficiency Anemia in Inflammatory Bowel Disease: A Systematic Review. Medicine (Baltimore). 2015 Jun;94(23):e963. doi: 10.1097/MD.0000000000000963.

  PMID: 26061331 BACKGROUND

• Nielsen OH, Coskun M, Weiss G. Iron replacement therapy: do we need new guidelines? Curr Opin Gastroenterol. 2016 Mar;32(2):128-35. doi: 10.1097/MOG.0000000000000247.

  PMID: 26771951 BACKGROUND

• Pisani A, Riccio E, Sabbatini M, Andreucci M, Del Rio A, Visciano B. Effect of oral liposomal iron versus intravenous iron for treatment of iron deficiency anaemia in CKD patients: a randomized trial. Nephrol Dial Transplant. 2015 Apr;30(4):645-52. doi: 10.1093/ndt/gfu357. Epub 2014 Nov 13.

  PMID: 25395392 BACKGROUND

• Antunes CV, Hallack Neto AE, Nascimento CR, Chebli LA, Moutinho IL, Pinheiro Bdo V, Reboredo MM, Malaguti C, Castro AC, Chebli JM. Anemia in inflammatory bowel disease outpatients: prevalence, risk factors, and etiology. Biomed Res Int. 2015;2015:728925. doi: 10.1155/2015/728925. Epub 2015 Feb 1.

  PMID: 25705682 RESULT

• Filmann N, Rey J, Schneeweiss S, Ardizzone S, Bager P, Bergamaschi G, Koutroubakis I, Lindgren S, Morena Fde L, Moum B, Vavricka SR, Schroder O, Herrmann E, Blumenstein I. Prevalence of anemia in inflammatory bowel diseases in european countries: a systematic review and individual patient data meta-analysis. Inflamm Bowel Dis. 2014 May;20(5):936-45. doi: 10.1097/01.MIB.0000442728.74340.fd.

  PMID: 24572205 RESULT

• Bonovas S, Fiorino G, Allocca M, Lytras T, Tsantes A, Peyrin-Biroulet L, Danese S. Intravenous Versus Oral Iron for the Treatment of Anemia in Inflammatory Bowel Disease: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Medicine (Baltimore). 2016 Jan;95(2):e2308. doi: 10.1097/MD.0000000000002308.

  PMID: 26765407 RESULT

MeSH Terms

Conditions

Anemia; Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Interventions

ferric pyrophosphate

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Carla VA Antunes, MSc. MD

  Federal University of Juiz de Fora

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carla VA Antunes, Master

CONTACT

+55(32)99123-1200; carlavaleria.aantunes@gmail.com

Julio MF Chebli, Doctor

CONTACT

+5(32)991210949; chebli@globo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2016
• First Posted: May 4, 2016
• Study Start: August 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2018
• Last Updated: August 9, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will share