Characteristics of Anemia in Celiac Disease

NCT05172895 | Completed

• 1 other identifier: ACPM28
• Study Type: observational
• Target: 159
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Celiac Disease

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (1)

• Pathogenic mechanisms of anemia

  At baseline (=before diagnosis, on a gluten-containing diet) and at follow-up (=after at least one year of GFD)

Interventions

Presence, prevalence, severity, and morphological characteristics of anemia OTHER

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.

Effect of gluten-free diet on anemia OTHER

Evaluation of the therapeutic responses (i.e., improvement/regression) of anemia after at least one year of GFD.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

We will enroll CD patients.

You may qualify if:

• CD will be diagnosed according to the current guidelines. In details, the following standard criteria will be adopted to diagnose CD ("4 out of 5" rule):
• gluten/wheat-dependent symptoms, both intestinal and extraintestinal
• positivity of anti-deamidated gluten peptides (DPG) IgA and IgG antibodies, anti-transglutainase (tTG) IgA and IgG antibodies, and endomysium antibodies (EMA)
• presence of crypt hyperplasia and duodenal villous atrophy on duodenal biopsy
• presence of HLA haplotypes DQ2 and/or DQ8
• resolution of symptoms with a rigorous GFD
• age \>18 and \<65 years
• complete clinical records
• clinical and laboratory follow-up of at least one year from diagnosis -

You may not qualify if:

• age \<18 and \>65 years
• incomplete medical records
• lack of clinical and laboratory follow-up of at least one year from diagnosis
• pregnancy
• alcohol and/or drug abuse
• diagnosis of IBD or other gastrointestinal organic disease

Sponsors & Collaborators

• University of Palermo: lead

Study Sites (3)

Department of Internal Medicine, Giovanni Paolo II Hospital of Sciacca

Sciacca, Agrigento, 92019, Italy

Location

Internal Medicine Division of the "Cervello-Villa Sofia" Hospital

Palermo, PA, 90146, Italy

Location

Department of Internal Medicine, University Hospital of Palermo

Palermo, 90129, Italy

Location

Related Publications (4)

• 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.

  PMID: 34684433 RESULT

• 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.

  PMID: 31652803 RESULT

• 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.

  PMID: 30850345 RESULT

• 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.

  PMID: 32708019 RESULT

MeSH Terms

Conditions

Celiac Disease

Interventions

Prevalence

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Morbidity; Vital Statistics; Data Collection; Epidemiologic Methods; Investigative Techniques; Demography; Population Characteristics; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Antonio Carroccio, MD

  University of Palermo

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 30, 2021
• First Posted: December 29, 2021
• Study Start: January 1, 2001
• Primary Completion: January 1, 2020
• Study Completion: July 31, 2021
• Last Updated: December 29, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3)