The Correlation Between Anemia of Chronic Diseases, Hepcidin and Vitamin D in IBD Patients

NCT03145896 | Unknown

• 1 other identifier: TASMC-15-SC-0778-CTIL
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Crohn's disease (CD) and ulcerative colitis (UC) are chronic gastrointestinal diseases characterized by relapsing and remitting inflammation of the intestines Anemia may often complicate the course of inflammatory bowel disease (IBD). The cause of anemia in IBD is multifactorial In the chronically ill patients, it has been described that the mechanism underlying anemia involves hepcidin.A potential mechanism underlying anemia during an chronic disease is suggested by recent data demonstrating a hepcidin lowering effect of vitamin D

Conditions

IBD

Keywords

vitamin D; Anemia; IBD

Outcome Measures

Primary Outcomes (1)

• influence of vitamin D on anemia of inflammation

  levels of hepcidin, IL6, vitamin D and anemia in children and adolescence with newly diagnosed IBD before and after vitamin D supplemntation.

  2 weeks

Study Arms (2)

IBD patients with Vitamin D treatment

ACTIVE COMPARATOR

Dietary Supplement: vitamin D

IBD patients with no Vitamin D treatment

NO INTERVENTION

Interventions

vitamin D DIETARY_SUPPLEMENT

After the gastroscopy all patients will be taught to take 4000 unit of vitamin D (25(OH)D) daily (not a specific brand) , for the next 2 week. All patients will be invited for follow-up in 2 weeks to get the histopathology result. In this encounter we will take again blood sample for 25(OH)D, calcium, phosphate, CRP and complete blood count including hemoglobin. a control group will not take the Vitamin D supplements.

IBD patients with Vitamin D treatment

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients with newly diagnosed IBD based on histopathology.

You may not qualify if:

• Patients that their histopathology will confirm eventually different diagnosis.
• Participants that are receiving medications known to alter vitamin D metabolism or have hepatic or renal disease
• Participants that suffer from hemoglobinopaties, bone marrow failure, or receive bone marrow suppressing agents
• Participants that went through a recent surgical procedure, or needed blood transfusion for any reason

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Related Publications (19)

• Podolsky DK. Inflammatory bowel disease. N Engl J Med. 2002 Aug 8;347(6):417-29. doi: 10.1056/NEJMra020831. No abstract available.

  PMID: 12167685 BACKGROUND

• Gasche C. Anemia in IBD: the overlooked villain. Inflamm Bowel Dis. 2000 May;6(2):142-150; discussion 151. doi: 10.1097/00054725-200005000-00013.

  PMID: 10833075 BACKGROUND

• de la Morena F, Gisbert JP. [Anemia and inflammatory bowel disease]. Rev Esp Enferm Dig. 2008 May;100(5):285-93. Spanish.

  PMID: 18662081 BACKGROUND

• de Silva AD, Mylonaki M, Rampton DS. Oral iron therapy in inflammatory bowel disease: usage, tolerance, and efficacy. Inflamm Bowel Dis. 2003 Sep;9(5):316-20. doi: 10.1097/00054725-200309000-00005.

  PMID: 14555915 BACKGROUND

• Gisbert JP, Gomollon F. Common misconceptions in the diagnosis and management of anemia in inflammatory bowel disease. Am J Gastroenterol. 2008 May;103(5):1299-307. doi: 10.1111/j.1572-0241.2008.01846.x.

  PMID: 18477354 BACKGROUND

• Basseri RJ, Nemeth E, Vassilaki ME, Basseri B, Enayati P, Shaye O, Bourikas LA, Ganz T, Papadakis KA. Hepcidin is a key mediator of anemia of inflammation in Crohn's disease. J Crohns Colitis. 2013 Sep;7(8):e286-91. doi: 10.1016/j.crohns.2012.10.013. Epub 2012 Dec 6.

  PMID: 23219355 BACKGROUND

• Yapakci E, Tarcan A, Celik B, Ozbek N, Gurakan B. Serum pro-hepcidin levels in term and preterm newborns with sepsis. Pediatr Int. 2009 Apr;51(2):289-92. doi: 10.1111/j.1442-200X.2008.02688.x.

  PMID: 19405934 BACKGROUND

• Nemeth E, Ganz T. The role of hepcidin in iron metabolism. Acta Haematol. 2009;122(2-3):78-86. doi: 10.1159/000243791. Epub 2009 Nov 10.

  PMID: 19907144 BACKGROUND

• Ruchala P, Nemeth E. The pathophysiology and pharmacology of hepcidin. Trends Pharmacol Sci. 2014 Mar;35(3):155-61. doi: 10.1016/j.tips.2014.01.004. Epub 2014 Feb 17.

  PMID: 24552640 BACKGROUND

• Ross SL, Tran L, Winters A, Lee KJ, Plewa C, Foltz I, King C, Miranda LP, Allen J, Beckman H, Cooke KS, Moody G, Sasu BJ, Nemeth E, Ganz T, Molineux G, Arvedson TL. Molecular mechanism of hepcidin-mediated ferroportin internalization requires ferroportin lysines, not tyrosines or JAK-STAT. Cell Metab. 2012 Jun 6;15(6):905-17. doi: 10.1016/j.cmet.2012.03.017.

  PMID: 22682226 BACKGROUND

• Dudkowiak R, Neubauer K, Poniewierka E. Hepcidin and its role in inflammatory bowel disease. Adv Clin Exp Med. 2013 Jul-Aug;22(4):585-91.

  PMID: 23986220 BACKGROUND

• Nemeth E, Valore EV, Territo M, Schiller G, Lichtenstein A, Ganz T. Hepcidin, a putative mediator of anemia of inflammation, is a type II acute-phase protein. Blood. 2003 Apr 1;101(7):2461-3. doi: 10.1182/blood-2002-10-3235. Epub 2002 Nov 14.

  PMID: 12433676 BACKGROUND

• Theurl I, Schroll A, Nairz M, Seifert M, Theurl M, Sonnweber T, Kulaksiz H, Weiss G. Pathways for the regulation of hepcidin expression in anemia of chronic disease and iron deficiency anemia in vivo. Haematologica. 2011 Dec;96(12):1761-9. doi: 10.3324/haematol.2011.048926. Epub 2011 Aug 22.

  PMID: 21859731 BACKGROUND

• Ferrucci L, Semba RD, Guralnik JM, Ershler WB, Bandinelli S, Patel KV, Sun K, Woodman RC, Andrews NC, Cotter RJ, Ganz T, Nemeth E, Longo DL. Proinflammatory state, hepcidin, and anemia in older persons. Blood. 2010 May 6;115(18):3810-6. doi: 10.1182/blood-2009-02-201087. Epub 2010 Jan 15.

  PMID: 20081092 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

• Oustamanolakis P, Koutroubakis IE, Messaritakis I, Malliaraki N, Sfiridaki A, Kouroumalis EA. Serum hepcidin and prohepcidin concentrations in inflammatory bowel disease. Eur J Gastroenterol Hepatol. 2011 Mar;23(3):262-8. doi: 10.1097/MEG.0b013e328343b885.

  PMID: 21285884 BACKGROUND

• Smith EM, Alvarez JA, Martin GS, Zughaier SM, Ziegler TR, Tangpricha V. Vitamin D deficiency is associated with anaemia among African Americans in a US cohort. Br J Nutr. 2015 Jun 14;113(11):1732-40. doi: 10.1017/S0007114515000999. Epub 2015 Apr 16.

  PMID: 25876674 BACKGROUND

• Bacchetta J, Zaritsky JJ, Sea JL, Chun RF, Lisse TS, Zavala K, Nayak A, Wesseling-Perry K, Westerman M, Hollis BW, Salusky IB, Hewison M. Suppression of iron-regulatory hepcidin by vitamin D. J Am Soc Nephrol. 2014 Mar;25(3):564-72. doi: 10.1681/ASN.2013040355. Epub 2013 Nov 7.

  PMID: 24204002 BACKGROUND

• Moran-Lev H, Galai T, Yerushalmy-Feler A, Weisman Y, Anafy A, Deutsch V, Cipok M, Lubetzky R, Cohen S. Vitamin D Decreases Hepcidin and Inflammatory Markers in Newly Diagnosed Inflammatory Bowel Disease Paediatric Patients: A Prospective Study. J Crohns Colitis. 2019 Sep 27;13(10):1287-1291. doi: 10.1093/ecco-jcc/jjz056.

  PMID: 30840757 DERIVED

MeSH Terms

Conditions

Anemia

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Phd

Study Record Dates

• First Submitted: April 5, 2017
• First Posted: May 9, 2017
• Study Start: June 1, 2017
• Primary Completion: June 1, 2018
• Study Completion: September 1, 2018
• Last Updated: May 9, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share