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NCT Number: NCT07014436

Prospective Cohort Study Evaluating Iron Supplementation in Patients With Altered Iron Status in the Context of Acute Inflammation (CARMI (CARence Martiale & Inflammation))

This study is a prospective, single center, open label cohort study evaluating iron supplementation in patients with impaired martial status in the acute inflammatory setting.

The main objective of this study is to evaluate the effectiveness of iron supplementation in anemic patients with inflammation and an altered iron status in the 'grey zone,' defined by a ferritin level between 30 and 300 µg/L and a transferrin saturation coefficient (TSC) of less than 20%, in the patient internal medicine/general medicine unit of the Grenoble Alpes University Hospital.

The primary endpoint is the difference in hemoglobin levels at 3 months after hospital discharge between patients treated with or without martial supplementation.

We hypothesize that iron supplementation more effectively improves hemoglobin levels at three months compared to no supplementation in patients with anemia and altered iron status (ferritin between 30 and 300 µg/L and a transferrin saturation coefficient (TSC) < 20%) in the context of acute inflammation.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital, Grenoble Alpes

La Tronche, 38700, France

Location contact

Alexis BOCQUET, Hospital Doctor

PRINCIPAL_INVESTIGATOR

Bruna DUCOTTERD, Clinical Research Associate

CONTACT

[email protected]

+33 4 76 76 78 38

About this study

The main objective of this study is to evaluate the effectiveness of iron supplementation in anaemic patients with inflammation and an altered iron status.

The primary endpoint is the difference in hemoglobin levels at 3 months after hospital discharge between patients treated with or without martial supplementation, and our hypothesis is that iron supplementation improves hemoglobin levels at three months compared to no supplementation in patients with anaemia and altered iron status (ferritin between 30 and 300 µg/L and a transferrin saturation coefficient (TSC) < 20%) in the context of acute inflammation.

The secondary objectives are to evaluate the effectiveness of iron supplementation in anaemic and inflammatory patients with iron status in the "grey zone" (ferritin between 30 and 300 µg/L and a transferrin saturation coefficient (TSC) < 20%), to identify demographic, clinical, and biological factors associated with the correction of anaemia in the iron-treated group, to identify demographic, clinical, and biological factors associated with the correction of anaemia in the non-iron-treated group and to assess the safety of iron supplementation.

Anemic patients (hemoglobin < 13 g/dL in men and < 12 g/dL in women), with inflammation (CRP > 30 mg/L), and iron status in the "grey zone" (ferritin between 30 and 300 µg/L and transferrin saturation < 20%) within the first three days of hospitalization are observed according to the iron supplementation strategy chosen as part of their routine care, allowing for a retrospective classification into two groups:

  • Group A: patients who received iron supplementation despite having ferritin between 30 and 300 µg/L and transferrin saturation coefficient (TSC) < 20%.
  • Group B: patients who did not receive iron supplementation despite ferritin between 30 and 300 µg/L and transferrin saturation coefficient (TSC) < 20%.

Sociodemographic and clinical data of the patients in each group will be collected to control for potential confounding factors in the statistical analysis.

Patients are included the day before or at the end of their hospital stay, once all medical decisions-including whether or not to administer iron-have been made independently of the study. No influence is exerted on therapeutic choices, which are based solely on the routine practices of hospital physicians.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Anemia (Hb < 130 g/L in men and < 120 g/L in women) within the first 3 days of hospitalization in the department
  • Biological signs of inflammation (CRP ≥ 30 mg/L) within the first 3 days of hospitalization in the department
  • Ferritin between 30 and 300 µg/L and a transferrin saturation coefficient (TSC) < 20% within the first 3 days of hospitalization in the department

Exclusion criteria

  • Patients who object to the use of their data for research purposes
  • Patients unable to provide informed consent to participate in the research
  • Patients who received a red blood cell transfusion during hospitalization or in the month prior
  • Patients receiving erythropoietin (EPO) treatment
  • Patients treated with iron supplementation within one month prior to hospitalization
  • Congenital hemoglobinopathy (e.g., thalassemia, sickle cell disease)
  • Chemotherapy within the past 3 months or planned chemotherapy within the next 3 month

Treatment and study plan

Primary outcomes

  1. Mean increase in hemoglobin

    Time frame: At 3 months (end of study)

    The improvement in anemia, represented by the mean hemoglobin level (g/L) measured at 3 months after hospitalization, between patients who received iron supplementation and those who did not.

    • Analysis population : All included patients
    • Statistical tests:
    • Student's t-test if the data are normally distributed with homogeneity of variances, particularly for hemoglobin.
    • Wilcoxon non-parametric test if normality assumptions are not met.
    • Multivariate analysis (ANCOVA) adjusted for potential confounding factors (age, sex, comorbidities, baseline CRP, baseline ferritin, baseline transferrin saturation coefficient (TSC)).

Secondary outcomes

  1. Correction of anemia :

    Time frame: At 3 months (end of study)

    Proportion of patients having corrected their anemia (hemoglobin level ≥ 13 g/dL in men, ≥ 12 g/dL in women).

    • Population : All included patients
    • Test : Comparison of proportions (Chi-squared test or Fisher's exact test, depending on whether normality assumptions are met
  2. Identify factors associated with anemia correction

    Time frame: At 3 months (end of study)

    Analysis of demographic (age, gender), clinical (comorbidities) and biological factors

    • Population : Treated and untreated subgroups
    • Test : Exploratory analysis using logistic regression
  3. Adverse events :

    Time frame: At 3 months (end of study)

    Incidence of adverse effects associated with iron supplementation (hypersensitivity, iron overload).

    • Population : Treated patients
    • Test : Descriptive analysis (counts, percentages)

Study contacts

Contact information is provided by the study sponsor or research team.

Bruna DUCOTTERD, Clinical Research Associate

CONTACT

[email protected]

+33 4 76 76 78 38

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Acronym: CARMI

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 11, 2025
Registry last updated
Jun 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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