NCT05514951

Brief Summary

Iron deficiency is defined by insufficient tissue iron stores and anemia is the ultimate stage of iron deficiency. Anemia should never be neglected in an elderly subject because it is associated with an increase in mortality, but also with a increased morbidity in terms of complications Apart from anemia, iron deficiency is common and constitutes a factor of poor prognosis in diseases chronic, all pathologies very frequently found in the elderly. It is the origin of the deterioration in the general condition of patients, their re-hospitalization or even the progression of their pathology. In this context where elderly patients also present a certain number of comorbidities including the pathologies mentioned previously, it is important to better diagnose the deficiency martial in the elderly patient.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
888

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 22, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 25, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

November 15, 2022

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 9, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 9, 2022

Completed
Last Updated

March 28, 2025

Status Verified

March 1, 2025

Enrollment Period

24 days

First QC Date

August 22, 2022

Last Update Submit

March 24, 2025

Conditions

Iron-deficiency

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients diagnosed with iron deficiency on inclusion

    The diagnosis of iron deficiency will be made from the measurements of the ferritinemia and CST: Ferritinemia \< 100 µg/L and/or CST \< 20%

    Day 1

Study Arms (1)

Blood sampling

EXPERIMENTAL

Blood sampling

Diagnostic Test: Blood sampling

Interventions

Blood samplingDIAGNOSTIC_TEST

Blood sampling

Blood sampling

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Any patient hospitalized in a geriatric unit (short geriatric stay, SSR) or seen on an outpatient basis (hospitalization day, consultation)
  • Affiliated patient or beneficiary of a social healthcare system
  • Patient having given written consent

You may not qualify if:

  • Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by court order or administration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Chu Angers

Angers, 49933, France

Location

CH de Bayonne

Bayonne, 64100, France

Location

Ch De Calais

Calais, 62107, France

Location

CH Chambéry

Chambéry, 73000, France

Location

CHSF

Corbeil-Essonnes, 91100, France

Location

Ch de Dunkerque

Dunkirk, 59385, France

Location

Hôpital Gériatrique Les Bateliers Chu Lille

Lille, 59037, France

Location

Chu De Nantes, Hôpital Bellier

Nantes, France, France

Location

CHU de NICE-hopital CIMIEZ

Nice, 6003, France

Location

Hopital Saint Antoine

Paris, 75571, France

Location

CH de Pau

Pau, 64000, France

Location

CHU de Poitiers

Poitiers, 86021, France

Location

HUS - Hôpitaux Universitaires de Starsbourg

Strasbourg, 67000, France

Location

Hôpital Bretonneau

Tours, 37044, France

Location

Chu Nancy

Vandœuvre-lès-Nancy, 54511, France

Location

HCL

Villeurbanne, 69100, France

Location

Related Publications (1)

  • Fougere B, Puisieux F, Chevalet P, Annweiler C, Michel E, Joly L, Blanc F, Azouzi AE, Desre-Follet V, Cacoub P; CARENFER PA study group*. Prevalence of iron deficiency in patients admitted to a geriatric unit: a multicenter cross-sectional study. BMC Geriatr. 2024 Jan 30;24(1):112. doi: 10.1186/s12877-024-04719-6.

    PMID: 38287253DERIVED

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Anemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2022

First Posted

August 25, 2022

Study Start

November 15, 2022

Primary Completion

December 9, 2022

Study Completion

December 9, 2022

Last Updated

March 28, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(16)