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
- Cystic fibrosis genetically proven.
- Age ≥ 18 years
- Systematic annual follow-up.
- Dietary or drugs iron supplements
- Systemic inflammation or pulmonary exacerbation
- Lung transplantation
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
Name Time Method
Trial Locations
- Locations (1)
Centre de Ressources et de Compétences de la Mucoviscidose adulte de Lyon - Centre Hospitalier Lyon Sud
🇫🇷Pierre-Bénite, France