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Iron Metabolism in Cystic Fibrosis

Conditions
Iron Metabolism, Cystic Fibrosis
Registration Number
NCT04584489
Lead Sponsor
Hospices Civils de Lyon
Brief Summary

Iron is a biologically essential micronutrient. Iron deficiency alters erythropoiesis and is considered as a major cause of disability worldwide. Interestingly, iron overload is never observed in cystic fibrosis contrarily to others chronic respiratory diseases. Moreover, iron deficiency reported prevalence in CF is very high (up to 60% in retrospective series) and is correlated to an alteration of respiratory function.

Cystic fibrosis patients should be tested annually for iron deficiency. Serum ferritin is the best diagnosis tool for iron deficiency (specificity 87% for a threshold \< 30 µg/L). Previously published studies used less performant markers such as serum iron (\< 12 µmol/L) or transferrin saturation (\< 12%), which are markedly influenced by the systemic inflammation. CF patients experiences frequent pulmonary exacerbations leading to systemic inflammation: iron stores should therefore be assessed at optimal time with no inflammation.

The I-MUCO study aims to determine the exact prevalence of iron deficiency in CF patients. We aimed to identify risk factors for iron deficiency onset.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
100
Inclusion Criteria
  • Cystic fibrosis genetically proven.
  • Age ≥ 18 years
  • Systematic annual follow-up.
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Exclusion Criteria
  • Dietary or drugs iron supplements
  • Systemic inflammation or pulmonary exacerbation
  • Lung transplantation
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
prevalence of iron deficiency defined by serum ferritin ≤ 30 µg/L without inflammatory syndrome (C-reactive protein < 5 mg/L).1 year

from inclusion to first documented up to 1 year

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Centre de Ressources et de Compétences de la Mucoviscidose adulte de Lyon - Centre Hospitalier Lyon Sud

🇫🇷

Pierre-Bénite, France

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