Iron Homoeostasis in Inflammation

Inflammation Clinical Trial

Official title:

Iron Homoeostasis in Inflammation: A Single Center Observational Cross-sectional Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02155114
• Other study ID #: EKNZ 2014-053
• Secondary ID: EKNZ 2014-053
• Status: Completed
• Phase: N/A
• First received: June 2, 2014
• Last updated: November 11, 2014
• Start date: April 2014

Study information

• Verified date: November 2014
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Federal Office of Public Health
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to survey iron storage levels and their prognostic consequences in the context of acute inflammation. The impact of iron substitution in inflammatory states is controversial. We hypothesize that iron substitution may influence outcome in patients in inflammatory states.

Description:

• Background: Iron deficiency is frequently encountered in the elderly, after bleeding and in the context of neoplasia. Our 2013 pilot study showed that iron deficiency is a common problem in medical inpatients (13.7%) and that about 55% of these also showed signs of inflammation. The relevance of iron storage levels on clinical outcome in the presence of inflammation is conflicting. On the one hand, lack of iron prevents many viruses and bacteria, as well as other microorganisms, to reproduce and on the other hand the abundance of available iron stimulates hematopoiesis and reduces symptoms of iron deficiency.

• Methodology: We plan to enroll 1000-1500 patients with laboratory signs of inflammation during a period of six months and to analyze iron specific laboratory parameters twice during hospital stay. Additional laboratory analyses are planned for a smaller sample to portray the processes in iron homeostasis during inflammation.

• Significance: Contradicting evidence of forty and more years of scientific research backs current therapeutic practices in patients with inflammatory disease and iron deficiency. This study records prevalence of different iron storage states, mortality, morbidity and therapies in inflammatory states combined with iron deficiency and could very well be able to recommend a therapeutic regimen as well as limits for typically used laboratory parameters.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 472
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Age: =18

• Hospitalized patient in internal medicine (= 24h)

• Evidence of an inflammatory state, determined as a C reactive protein (CRP) value >5 mg/l

• Written informed consent

Exclusion Criteria:

• History of terminal renal insufficiency in terms of dialysis or use of erythropoiesis-stimulating agents

• Pregnancy

• History of allogeneic stem cell transplantation

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Bacterial Infections
• Bacterial Infections and Mycoses
• Inflammation
• Iron Overload

Locations

Country	Name	City	State
Switzerland	Basel University Hospital	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

References & Publications (5)

Drakesmith H, Prentice AM. Hepcidin and the iron-infection axis. Science. 2012 Nov 9;338(6108):768-72. doi: 10.1126/science.1224577. Review. — View Citation

Finberg KE. Unraveling mechanisms regulating systemic iron homeostasis. Hematology Am Soc Hematol Educ Program. 2011;2011:532-7. doi: 10.1182/asheducation-2011.1.532. Review. — View Citation

Hug BL, Tichelli A, Benkert P, Stirnimann G, Schifferli JA. Diagnosis and treatment of iron deficiency in medical inpatients at a Swiss tertiary university referral hospital: a retrospective observational cohort study of clinical practice. Swiss Med Wkly. 2013 Sep 6;143:w13847. doi: 10.4414/smw.2013.13847. — View Citation

Oppenheimer SJ. Iron and its relation to immunity and infectious disease. J Nutr. 2001 Feb;131(2S-2):616S-633S; discussion 633S-635S. Review. — View Citation

Thomas DW, Hinchliffe RF, Briggs C, Macdougall IC, Littlewood T, Cavill I; British Committee for Standards in Haematology. Guideline for the laboratory diagnosis of functional iron deficiency. Br J Haematol. 2013 Jun;161(5):639-48. doi: 10.1111/bjh.12311. Epub 2013 Apr 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of different iron states (normal iron states, iron deficiency and iron overload) in the context of acute inflammation		up to 8 days	No
Secondary	Correlation between iron states and clinical course of acute inflammation, mode of discharge and iron substitution		up to 8 days	No