Iron Status Assessment in Geriatric Elderly

NCT07739524 | Not Yet Recruiting

• 1 other identifier: CHUO-2025-18
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

In elderly adults, anemia is common and multifactorial. Inflammation, which is frequently observed in hospitalized elderly patients, profoundly alters iron metabolism, making it difficult to accurately assess true iron status. The objective of this study is to identify a predictive model that can estimate iron deficiency status in the absence of inflammation using transferrin saturation (TSAT) measured during an inflammatory phase. This model could help distinguish true iron deficiency from anemia of inflammation, improve patient management, and reduce decision-making delays. The study will be conducted in two distinct phases: a pilot phase involving up to 200 patients at a single center in France, followed by a main phase involving 1,523 patients across multiple centers in France. Participants will be adults aged over 75 years who are hospitalized in a geriatric ward and present with an acute inflammatory episode (C-reactive protein \[CRP\] \> 50 mg/L). In addition to routine analyses performed during hospitalization, supplementary laboratory analyses will be carried out. Following admission in hospital, patients will receive standard medical care. Upon admission or on the following day, patients, their trusted representative, or relatives will be informed about the study. If eligibility criteria are met, the patient will be enrolled. Research-specific laboratory analyses will be performed on blood samples collected at 4 times:

• the day after admission;
• when CRP \< 20 mg/L (pilot phase only);
• when CRP \< 10 mg/L;
• five days after a CRP \< 10 mg/L. These additional analyses will not require another blood sample, as they will be performed on samples collected as part of routine clinical care. They constitute the main research specific intervention.

Conditions

Elderly; Acute Inflammatory Response; Iron Deficiency

Keywords

Transferrin Saturation; Iron Parameters; Inflammation; Elderly; Predictive model

Outcome Measures

Primary Outcomes (2)

• Proportion of patients with iron deficiency, defined as transferrin saturation < 20% (pilot phase)

  To estimate the proportion of patients with iron deficiency, defined as transferrin saturation (TSAT) \< 20%, in order to validate the prevalence assumption that will be used in the sample size calculation for the development of a predictive model of iron deficiency under non-inflammatory conditions

  From enrollment to the end of study at 4 weeks maximum

• To develop a predictive model for iron deficiency, defined by TSAT under non-inflammatory conditions (defined as CRP<10 mg/L or <20 mg/L, depending on results of pilot phase), using measurements obtained during acute inflammatory episode (main phase)

  Transferrin saturation (TSAT) will be measured at baseline and when CRP \< 10 mg/L (or \< 20 mg/L, depending on results of the pilot phase). Iron deficiency will be defined as a TSAT \< 20%. The predictive performance of the model for estimating TSAT under non-inflammatory conditions and the agreement between predicted and observed TSAT values under non-inflammatory conditions will be assessed.

  From enrollment to the end of study at 4 weeks maximum

Secondary Outcomes (5)

• Proportion of patients with CRP < 20 mg/L and proportion of patients with CRP < 10 mg/L in the study population (pilot phase)

  From enrollment to the end of study at 4 weeks maximum

• Among the clinically relevant variables, and within subgroups of patients with CRP < 20 mg/L and < 10 mg/L (pilot phase), to examine a/the collinearity structure among potential predictors ; b/the distribution of categorical variables

  From enrollment to the end of study at 4 weeks maximum

• To assess the correlation between transferrin saturation measured during an inflammatory state and transferrin saturation measured under non-inflammatory conditions.

  From enrollment to the end of study at 4 weeks maximum

• To develop and validate a predictive model for iron deficiency, defined by ferritin levels under non-inflammatory conditions, with non-inflammation defined as CRP < 10 mg/L (or < 20 mg/L, depending on the results of the pilot phase).

  From enrollment to the end of study at 4 weeks maximum

• To assess the evolution of iron status parameters when CRP < 10mg/l and 5 days post CRP < 10mg/l.

  From enrollment to the end of study at 4 weeks maximum

Study Arms (1)

Elderly patients with acute inflammation

Hospitalized patients aged \>75 years admitted to hospital with an acute inflammatory episode (CRP \> 50 mg/L).

Diagnostic Test: Analysis of biological parameters

Interventions

Analysis of biological parameters DIAGNOSTIC_TEST

Research-specific analyses will be performed on the following blood samples: * Day 0 : reticulocyte count, reticulocyte hemoglobin content (Ret-He), percentage of hypochromic red blood cells, Delta-He, serum iron, transferrin, transferrin saturation (TSAT, %), ferritin, soluble transferrin receptor, and hepcidin. * CRP \< 20 mg/L (pilot phase only): reticulocyte count, reticulocyte hemoglobin content, percentage of hypochromic red blood cells, Delta-He, serum iron, transferrin, TSAT (%), ferritin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (AP), total bilirubin, albumin, and creatine phosphokinase (CPK). * CRP \< 10 mg/L: reticulocyte count, reticulocyte hemoglobin content, percentage of hypochromic red blood cells, Delta-He, serum iron, transferrin, TSAT (%), ferritin, , AST, ALT, AP, total bilirubin, albumin, and CPK. * 5 days after CRP \< 10 mg/L: same as CRP \< 10 mg/L

Elderly patients with acute inflammation

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Eligible patients will be recruited from among elderly adults hospitalized for acute condition associated with a biologically documented inflammatory syndrome and for whom laboratory follow-up can be performed during and after the acute inflammatory episode.

You may qualify if:

• Age ≥ 75 years.
• Hospitalization with CRP \> 50 mg/L at admission.
• Non-opposition expressed by patient or legally authorized representative

You may not qualify if:

• Advanced chronic kidney disease (estimated glomerular filtration rate \< 30 mL/min/1.73 m²) or chronic dialysis.
• Severe hepatic impairment (Child-Pugh score B or C).
• Severe hematological disorders (active hematologic malignancy or known myelodysplastic syndrome) or known iron metabolism disorders that may bias the study results (e.g., thalassemia, advanced hemochromatosis).
• Hemoglobin \< 9g/L
• Treatment with intravenous iron within 12 weeks or oral iron within 4 weeks prior to enrollment.
• Blood transfusion within 3 months prior to enrollment
• Ongoing treatment with erythropoiesis-stimulating agents.
• Ongoing cytotoxic chemotherapy.
• Active bleeding at the time of enrollment.
• Very limited life expectancy or inability to ensure follow-up (end-of-life care).
• Participation in another investigational medicinal product study

Sponsors & Collaborators

• Centre Hospitalier Régional d'Orléans: lead

Study Sites (1)

Centre Hospitalier Universitaire d'Orléans

Orléans, Loiret, 45067, France

Location

Related Publications (7)

• Butler CC, Gillespie D, White P, Bates J, Lowe R, Thomas-Jones E, Wootton M, Hood K, Phillips R, Melbye H, Llor C, Cals JWL, Naik G, Kirby N, Gal M, Riga E, Francis NA. C-Reactive Protein Testing to Guide Antibiotic Prescribing for COPD Exacerbations. N Engl J Med. 2019 Jul 11;381(2):111-120. doi: 10.1056/NEJMoa1803185.

  PMID: 31291514 BACKGROUND

• Miravitlles M, Moragas A, Hernandez S, Bayona C, Llor C. Is it possible to identify exacerbations of mild to moderate COPD that do not require antibiotic treatment? Chest. 2013 Nov;144(5):1571-1577. doi: 10.1378/chest.13-0518.

  PMID: 23807094 BACKGROUND

• Carmona C, Bewick T, Macduff N, Thomas A; Guideline Committee. Suspected acute respiratory infection in over 16s: assessment at first presentation and initial management-summary of NICE guidance. BMJ. 2024 Mar 11;384:q339. doi: 10.1136/bmj.q339. No abstract available.

  PMID: 38467421 BACKGROUND

• Cichon B, Ritz C, Fabiansen C, Christensen VB, Filteau S, Friis H, Kaestel P. Assessment of Regression Models for Adjustment of Iron Status Biomarkers for Inflammation in Children with Moderate Acute Malnutrition in Burkina Faso. J Nutr. 2017 Jan;147(1):125-132. doi: 10.3945/jn.116.240028. Epub 2016 Nov 23.

  PMID: 27881597 BACKGROUND

• Namaste SM, Rohner F, Huang J, Bhushan NL, Flores-Ayala R, Kupka R, Mei Z, Rawat R, Williams AM, Raiten DJ, Northrop-Clewes CA, Suchdev PS. Adjusting ferritin concentrations for inflammation: Biomarkers Reflecting Inflammation and Nutritional Determinants of Anemia (BRINDA) project. Am J Clin Nutr. 2017 Jul;106(Suppl 1):359S-371S. doi: 10.3945/ajcn.116.141762. Epub 2017 Jun 14.

  PMID: 28615259 BACKGROUND

• McSorley ST, Tham A, Jones I, Talwar D, McMillan DC. Regression Correction Equation to Adjust Serum Iron and Ferritin Concentrations Based on C-Reactive Protein and Albumin in Patients Receiving Primary and Secondary Care. J Nutr. 2019 May 1;149(5):877-883. doi: 10.1093/jn/nxz008.

  PMID: 31050746 BACKGROUND

• McSorley ST, Jones I, McMillan DC, Talwar D. Quantitative data on the magnitude of the systemic inflammatory response and its relationship with serum measures of iron status. Transl Res. 2016 Oct;176:119-26. doi: 10.1016/j.trsl.2016.05.004. Epub 2016 Jun 6.

  PMID: 27337525 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Analysis of biological parameters without additional blood sampling (using blood samples collected as part of routine clinical practice)

MeSH Terms

Conditions

Iron Deficiencies; Inflammation

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Moez JALLOULI, Principal Investigator

CONTACT

02 38 61 30 15; moez.jallouli@chu-orleans.fr

Fanny LOUAT

CONTACT

0238744295; fanny.louat@chu-orleans.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: July 31, 2026
• Study Start: July 29, 2026
• Primary Completion (Estimated): August 29, 2027
• Study Completion (Estimated): August 29, 2027
• Last Updated: July 31, 2026

Record last verified: 2026-07

Locations

FR (1)