Characteristics of Anemia in Celiac Disease
Clinical Characteristics and Pathogenic Mechanisms of Anemia in Celiac Disease
Clinical Characteristics and Pathogenic Mechanisms of Anemia in Celiac Disease
Sponsor study identifier
observational
159
1 country
3
Study Start
January 1, 2001
Actual (reported)Primary Completion
January 1, 2020
Actual (reported)Study Completion
July 31, 2021
Actual (reported)Celiac Disease (CD) is an autoimmune disease involving the mucosa of the small intestine, triggered by the ingestion of gluten in genetically predisposed individuals. CD represents a global health problem. The clinical presentation of CD is characterized by a broad spectrum of both intestinal and extraintestinal manifestations, involving one or more organs. Anemia is one of the most common extraintestinal clinical manifestations of CD, present in more than half of adult patients at the time of diagnosis. Anemia in CD has a multifactorial pathogenesis: a) lack of absorption (or, sometimes, loss, as in the case of iron), of some micronutrients, such as iron, folate, vitamin B12, copper and zinc, b) coexistence of a chronic inflammatory state, as in the case of inflammatory bowel disease (IBD), c) refractory CD, d) medullary aplasia. The main purpose of this multicentre research is to evaluate, retrospectively, analyzing the clinical and laboratory data of CD patients, the presence, prevalence, severity, and morphological characteristics of anemia, trying to define, when possible, the underlying pathogenetic mechanisms, paying particular attention to the characteristics of menstrual cycles, the iron, folate and vitamin B12 metabolism, any chronic inflammatory state, and thyroid hormones. It will be also recorded, in a subgroup of the selected CD patients, any therapeutic responses (i.e., improvement/regression) of anemia after at least one year of GFD.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 31, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2001
Actual (reported)January 1, 2020
Actual (reported)July 31, 2021
Actual (reported)November 30, 2021
Actual (reported)December 29, 2021
Actual (reported)Presence, severity and morphologic characteristic of anemia
Blood count to evaluate red cell count and morphology
At baseline (=before diagnosis, on a gluten-containing diet) and at follow-up (=after at least one year of GFD)
Pathogenic mechanisms of anemia
At baseline (=before diagnosis, on a gluten-containing diet) and at follow-up (=after at least one year of GFD)
Evaluation of the presence, prevalence, severity, and morphological characteristics of anemia, trying to define, when possible, the underlying pathogenetic mechanisms, paying particular attention to the characteristics of menstrual cycles, the iron, folate and vitamin B12 metabolism, any chronic inflammatory state, and thyroid hormones.
Evaluation of the therapeutic responses (i.e., improvement/regression) of anemia after at least one year of GFD.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
We will enroll CD patients.
Department of Internal Medicine, Giovanni Paolo II Hospital of Sciacca
Sciacca, Agrigento, 92019, Italy
Internal Medicine Division of the "Cervello-Villa Sofia" Hospital
Palermo, PA, 90146, Italy
Department of Internal Medicine, University Hospital of Palermo
Palermo, 90129, Italy
Montoro-Huguet MA, Santolaria-Piedrafita S, Canamares-Orbis P, Garcia-Erce JA. Iron Deficiency in Celiac Disease: Prevalence, Health Impact, and Clinical Management. Nutrients. 2021 Sep 28;13(10):3437. doi: 10.3390/nu13103437.
Martin-Masot R, Nestares MT, Diaz-Castro J, Lopez-Aliaga I, Alferez MJM, Moreno-Fernandez J, Maldonado J. Multifactorial Etiology of Anemia in Celiac Disease and Effect of Gluten-Free Diet: A Comprehensive Review. Nutrients. 2019 Oct 23;11(11):2557. doi: 10.3390/nu11112557.
Antonio Carroccio, MD
University of Palermo
159 participants (actual enrollment reported by the registry).
First Submitted
November 30, 2021
First Posted
December 29, 2021
Study Start
January 1, 2001
Actual (reported)Effectiveness of PENTABIOCEL in Clinical and Laboratory Recovery of Children With Celiac Disease
Contact the study team to confirm eligibility.
Elli L, Norsa L, Zullo A, Carroccio A, Girelli C, Oliva S, Romano C, Leandro G, Bellini M, Marmo R, Soncini M, Monica F, De Francesco V, Paulon E, Cappellini MD, Motta I, Ferretti F, Orlando S, Mansueto P, Buscarini E, Manfredi G, Agostoni C, Tomba C, Cannizzaro R. Diagnosis of chronic anaemia in gastrointestinal disorders: A guideline by the Italian Association of Hospital Gastroenterologists and Endoscopists (AIGO) and the Italian Society of Paediatric Gastroenterology Hepatology and Nutrition (SIGENP). Dig Liver Dis. 2019 Apr;51(4):471-483. doi: 10.1016/j.dld.2019.01.022. Epub 2019 Feb 11.
Stefanelli G, Viscido A, Longo S, Magistroni M, Latella G. Persistent Iron Deficiency Anemia in Patients with Celiac Disease Despite a Gluten-Free Diet. Nutrients. 2020 Jul 22;12(8):2176. doi: 10.3390/nu12082176.
Primary Completion
January 1, 2020
Actual (reported)Study Completion
July 31, 2021
Actual (reported)Last Updated
December 29, 2021
Record last verified: 2021-12
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Source: ClinicalTrials.gov.
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