Iron Metabolism in Cystic Fibrosis

NCT ID: NCT04584489

Last Updated: 2020-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-01

Study Completion Date

2021-02-01

Brief Summary

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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

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Conditions

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Iron Metabolism, Cystic Fibrosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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iron stores assessment.

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Pierre-Bénite, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Quitterie REYNAUD, MD

Role: CONTACT

00334 78 56 91 05

Herve LOBBES, MD

Role: CONTACT

Facility Contacts

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Quitterie REYNAUD, Dr

Role: primary

Marie VIPREY

Role: backup

Other Identifiers

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69HCL20_0793

Identifier Type: -

Identifier Source: org_study_id

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