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Completed

NCT Number: NCT02155114

Iron Homoeostasis in Inflammation

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.

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Key information

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Prevalence of different iron states (normal iron states, iron deficiency and iron overload) in the context of acute inflammation

    Time frame: up to 8 days

Secondary outcomes

  1. Correlation between iron states and clinical course of acute inflammation, mode of discharge and iron substitution

    Time frame: up to 8 days

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
First posted
Jun 4, 2014
Registry last updated
Nov 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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