Anemia Clinical Trial
— IBDOfficial title:
Anemia Treatment in Inflammatory Bowel Disease: Predictive Factors of Response to Oral Iron Treatment
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.
Status | Not yet recruiting |
Enrollment | 200 |
Est. completion date | August 2018 |
Est. primary completion date | August 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion criteria: - Diagnosis of inflammatory bowel disease (Crohn's disease or ulcerative colitis ) in remission - Anemia Exclusion criteria: - 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. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Federal University of Juiz de Fora |
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. — View Citation
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. — View Citation
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. — View Citation
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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 (Bal — View Citation
Filmann N, Rey J, Schneeweiss S, Ardizzone S, Bager P, Bergamaschi G, Koutroubakis I, Lindgren S, Morena Fde L, Moum B, Vavricka SR, Schröder O, Herrmann E, Blumenstein I. Prevalence of anemia in inflammatory bowel diseases in european countries: a system — View Citation
Gasche C, Ahmad T, Tulassay Z, Baumgart DC, Bokemeyer B, Büning 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. — View Citation
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. — View Citation
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. Review. — View Citation
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. — View Citation
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. Review. — View Citation
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* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | Improvement of quality of life | The IBDQ questionnaire data will be applied before and after treatment. Our study will use the following quality of life classification: Equal to or higher than 200 = Excellent; Between 151 and 199 = Good; Between 101 and 150 = Regular; Lower than or equal to 100 = Poor. | 8 weeks | No |
Secondary | Improvement of fatigue | The participants will be instructed to answer the questionnaire on fatigue (Chalder Fatigue Scale - attached) before and 8 weeks after the oral iron treatment. The questionnaire comprises 12 items related to the intensity of fatigue symptoms. It is a Likert-type scale with scores ranging from one to four in each item. The items are calculated in bimodal scores. Considering the Likert scale, the values ranging from one to four in bimodal calculations will be considered zero. Values such as three and four will be considered one. The sum in which the value is greater than or equal to four will feature fatigue |
8 weeks | No |
Secondary | Activation of inflammation | The inflammatory activity will be assessed according to the Harvey-Bradshaw Index for CD patients and UC patients will be assessed according to the Truelove and Witts criteria. | 8 weeks | No |
Secondary | Improvement of anxiety and depression | The participants will be instructed to answer the questionnaire on anxiety and depression (HAD scale) before and 8 weeks after the oral iron treatment. The questionnaire comprises 14 items related to anxiety and depression symptoms. It is considered anxiety if obtained 9 or more points, in items of anxiety and no-anxiety if below 8 points. The same criteria is used for depression. |
8 weeks | No |
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