Iron status prediction in elderly with inflammation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational study designed to develop and validate a predictive model that estimates iron deficiency using transferrin saturation measured during an inflammatory episode. The pilot phase will enroll up to 200 participants at a single French center to estimate the prevalence of iron deficiency (TSAT < 20%) and inform sample size. The main phase will enroll about 1,523 patients across multiple centers in France to develop and validate the model in a real-world geriatric hospitalized population. Adults aged 75+ with CRP > 50 mg/L at admission are included, while several medical exclusions apply to avoid bias. The primary goal is to distinguish true iron deficiency from anemia of inflammation to improve management and reduce delays in decision-making.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

Exclusion Criteria:

1. Advanced chronic kidney disease (estimated glomerular filtration rate \< 30 mL/min/1.73 m²) or chronic dialysis.
2. Severe hepatic impairment (Child-Pugh score B or C).
3. 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).
4. Hemoglobin \< 9g/L
5. Treatment with intravenous iron within 12 weeks or oral iron within 4 weeks prior to enrollment.
6. Blood transfusion within 3 months prior to enrollment
7. Ongoing treatment with erythropoiesis-stimulating agents.
8. Ongoing cytotoxic chemotherapy.
9. Active bleeding at the time of enrollment.
10. Very limited life expectancy or inability to ensure follow-up (end-of-life care).
11. Participation in another investigational medicinal product study

Where it's running

• Centre Hospitalier Universitaire d'Orléans
  Orléans, Loiret, France Recruiting

Study contacts

• Study coordinator: Moez JALLOULI, Principal Investigator
• Email: moez.jallouli@chu-orleans.fr
• Phone: 02 38 61 30 15

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Lactoferrin with low-dose iron to boost iron levels and aerobic fitness in active women

  We will test whether taking lactoferrin with a small daily dose of iron helps raise iron stores and improve aerobic performance in menstruating women with low ferritin.

  Recruiting Lindenwood University · Saint Charles, Missouri · NCT07546591

• AI-guided risk alerts to help doctors spot iron deficiency

  This trial tests whether an AI risk alert shown to clinicians after a CBC helps them detect iron deficiency more often in adult outpatients.

  Recruiting China Medical University Hospital · Taichung · NCT07394088

• Intravenous iron infusion after transcatheter aortic valve implantation for people with iron deficiency

  This trial will test whether an intravenous iron infusion after TAVI helps people aged 65 and older with severe aortic stenosis and iron deficiency feel better and walk farther.

  Recruiting Phase 4 Erasmus Medical Center · Rotterdam, South Holland · NCT07370688

• Intravenous iron to improve exercise capacity and quality of life in pulmonary hypertension

  This trial will test whether intravenous ferric carboxymaltose can improve exercise ability and quality of life in adults with pulmonary hypertension who have iron deficiency.

  Recruiting Phase 4 Ziekenhuis Oost-Limburg · Aalst and 6 other locations · NCT07359599

• Preoperative IV iron for teens having spinal fusion to correct scoliosis

  This trial will try giving a single IV iron infusion before spinal fusion to see if it helps 10–19-year-olds with scoliosis and low iron by reducing blood transfusions and improving recovery.

  Recruiting Phase 2/3 Columbia University · New York, New York · NCT07217873

• Non-invasive zinc protoporphyrin screening for iron deficiency in pregnancy

  This project tests a handheld device that measures zinc protoporphyrin through the lower lip to detect iron deficiency in pregnant and recently postpartum people.

  Recruiting Wuerzburg University Hospital · Würzburg, Bavaria · NCT07083492

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.