Iron Metabolism in Cystic Fibrosis

Iron Metabolism, Cystic Fibrosis Clinical Trial

Official title:

Prevalence and Incidence of Iron Deficiency in Cystic Fibrosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04584489
• Other study ID #: 69HCL20_0793
• Status: Recruiting
• Start date: February 1, 2020
• Est. completion date: February 1, 2021

Study information

• Verified date: August 2020
• Source: Hospices Civils de Lyon
• Contact: Quitterie REYNAUD, MD
• Phone: 00334 78 56 91 05
• Email: mailto:quitterie.reynaud[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 1, 2021
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Cystic fibrosis genetically proven.

• Age = 18 years

• Systematic annual follow-up.

Exclusion Criteria:

• Dietary or drugs iron supplements

• Systemic inflammation or pulmonary exacerbation

• Lung transplantation

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis
• Iron Metabolism, Cystic Fibrosis

Intervention

Other:
• iron stores assessment.
assessment of iron stores by measuring serum ferritin level (mandatory), serum iron and transferrin saturation.

Locations

Country	Name	City	State
France	Centre de Ressources et de Compétences de la Mucoviscidose adulte de Lyon - Centre Hospitalier Lyon Sud	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prevalence of iron deficiency defined by serum ferritin = 30 µg/L without inflammatory syndrome (C-reactive protein < 5 mg/L).	from inclusion to first documented up to 1 year	1 year