AnemiaCARMINCT07014436
Prospective Cohort Study Evaluating Iron Supplementation in Patients With Altered Iron Status in the Context of Acute Inflammation (CARMI (CARence Martiale & Inflammation))
An observational study of Anemia and Inflammation, run by University Hospital, Grenoble at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia, Inflammation
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects included in the study will be recruited from patients hospitalised in the various units of the Internal and Polyvalent Medicine Department at Grenoble Alpes University Hospital (Internal Medicine 3eA, Post-Emergency Unit 3eB and Internal Medicine 3eC).
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
University Hospital, Grenoble Alpes
La Tronche, 38700
Bruna DUCOTTERD, Clinical Research Associate, +33 4 76 76 78 38, bducotterd@chu-grenoble.fr
Alexis BOCQUET, Hospital Doctor
About this study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Anemia, Inflammation
- Keywords
- cohort, anemia, inflammation, prospective, iron supplementation
- Medical subject headings
- Anemia, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group A (iron supplementation) | Patients who have received oral or IV iron as part of routine care for a ferritin between 30 and 300 µg/L and a transferrin saturation coefficient (TSC) < 20%. | |
| Group B (without iron supplementation) | Patients who did not receive iron, despite a ferritin between 30 and 300 µg/L and a transferrin saturation coefficient (TSC) < 20%. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean increase in hemoglobin
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)).
Measured: At 3 months (end of study)
Secondary outcomes (3)
Correction of anemia :
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
Measured: At 3 months (end of study)
Identify factors associated with anemia correction
Analysis of demographic (age, gender), clinical (comorbidities) and biological factors
- Population : Treated and untreated subgroups
- Test : Exploratory analysis using logistic regression
Measured: At 3 months (end of study)
Adverse events :
Incidence of adverse effects associated with iron supplementation (hypersensitivity, iron overload).
- Population : Treated patients
- Test : Descriptive analysis (counts, percentages)
Measured: At 3 months (end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study startJun 2025 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexis BOCQUET, Hospital Doctor, Principal investigator, University Hospital, Grenoble Alpes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07014436
- Sponsor's protocol ID
- 38RC25.0094
- Acronym
- CARMI
- Status last verified
- Jun 2025
- First submitted
- 26 May 2025
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Fletcher A, Forbes A, Svenson N, Wayne Thomas D; A British Society for Haematology Good Practice Paper. Guideline for the laboratory diagnosis of iron deficiency in adults (excluding pregnancy) and children. Br J Haematol. 2022 Feb;196(3):523-529. doi: 10.1111/bjh.17900. Epub 2021 Oct 24. No abstract available.
PubMed 34693519Kiani AK, Dhuli K, Donato K, Aquilanti B, Velluti V, Matera G, Iaconelli A, Connelly ST, Bellinato F, Gisondi P, Bertelli M. Main nutritional deficiencies. J Prev Med Hyg. 2022 Oct 17;63(2 Suppl 3):E93-E101. doi: 10.15167/2421-4248/jpmh2022.63.2S3.2752. eCollection 2022 Jun.
PubMed 36479498Shepshelovich D, Rozen-Zvi B, Avni T, Gafter U, Gafter-Gvili A. Intravenous Versus Oral Iron Supplementation for the Treatment of Anemia in CKD: An Updated Systematic Review and Meta-analysis. Am J Kidney Dis. 2016 Nov;68(5):677-690. doi: 10.1053/j.ajkd.2016.04.018. Epub 2016 Jun 16.
PubMed 27321965Romanet T, Bedouch P, Zaoui P. [Assessment of iron deficiency anemia management in the general hospital of Grenoble: A 12-month follow-up of an intravenous ferric carboxymaltose treatment program in a cohort of patients with non-dialysis-dependent chronic kidney disease]. Nephrol Ther. 2019 Apr;15(2):104-109. doi: 10.1016/j.nephro.2018.10.006. Epub 2019 Feb 23. French.
PubMed 30803900Agrawal S, Sonawane S, Kumar S, Acharya S, Gaidhane SA, Wanjari A, Kabra R, Phate N, Ahuja A. Efficacy of Oral Versus Injectable Iron in Patients With Chronic Kidney Disease: A Two-Year Cross-Sectional Study Conducted at a Rural Teaching Hospital. Cureus. 2022 Jul 31;14(7):e27529. doi: 10.7759/cureus.27529. eCollection 2022 Jul.
PubMed 36060352Sieske L, Janssen G, Babel N, Westhoff TH, Wirth R, Pourhassan M. Inflammation, Appetite and Food Intake in Older Hospitalized Patients. Nutrients. 2019 Aug 22;11(9):1986. doi: 10.3390/nu11091986.
PubMed 31443557Petry N, Olofin I, Hurrell RF, Boy E, Wirth JP, Moursi M, Donahue Angel M, Rohner F. The Proportion of Anemia Associated with Iron Deficiency in Low, Medium, and High Human Development Index Countries: A Systematic Analysis of National Surveys. Nutrients. 2016 Nov 2;8(11):693. doi: 10.3390/nu8110693.
PubMed 27827838
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study Evaluating Iron Supplementation in Patients With Altered Iron Status in the Context of Acute Inflammation (CARMI (CARence Martiale & Inflammation))
- ClinicalTrials.gov ID
- NCT07014436
- Acronym / sponsor ID
- CARMI / 38RC25.0094
- Conditions
- Anemia, Inflammation
- Keywords
- cohort, anemia, inflammation, prospective, iron supplementation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Jun 2025 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 11 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (iron supplementation) | – | –Patients who have received oral or IV iron as part of routine care for a ferritin between 30 and 300 µg/L and a transferrin saturation coefficient (TSC) < 20%. |
| Group B (without iron supplementation) | – | –Patients who did not receive iron, despite a ferritin between 30 and 300 µg/L and a transferrin saturation coefficient (TSC) < 20%. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects included in the study will be recruited from patients hospitalised in the various units of the Internal and Polyvalent Medicine Department at Grenoble Alpes University Hospital (Internal Medicine 3eA, Post-Emergency Unit 3eB and Internal Medicine 3eC).
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)).
3 secondary outcomes
Correction of anemia :
Time frame: At 3 months (end of study)
Identify factors associated with anemia correction
Time frame: At 3 months (end of study)
Adverse events :
Time frame: At 3 months (end of study)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- Background: PubMed 34693519Fletcher A, Forbes A, Svenson N, Wayne Thomas D; A British Society for Haematology Good Practice Paper. Guideline for the laboratory diagnosis of iron deficiency in adults (excluding pregnancy) and children. Br J Haematol. 2022 Feb;196(3):523-529. doi: 10.1111/bjh.17900. Epub 2021 Oct 24. No abstract available.
- Background: PubMed 36479498Kiani AK, Dhuli K, Donato K, Aquilanti B, Velluti V, Matera G, Iaconelli A, Connelly ST, Bellinato F, Gisondi P, Bertelli M. Main nutritional deficiencies. J Prev Med Hyg. 2022 Oct 17;63(2 Suppl 3):E93-E101. doi: 10.15167/2421-4248/jpmh2022.63.2S3.2752. eCollection 2022 Jun.
- Results publication: PubMed 27321965Shepshelovich D, Rozen-Zvi B, Avni T, Gafter U, Gafter-Gvili A. Intravenous Versus Oral Iron Supplementation for the Treatment of Anemia in CKD: An Updated Systematic Review and Meta-analysis. Am J Kidney Dis. 2016 Nov;68(5):677-690. doi: 10.1053/j.ajkd.2016.04.018. Epub 2016 Jun 16.
- Results publication: PubMed 30803900Romanet T, Bedouch P, Zaoui P. [Assessment of iron deficiency anemia management in the general hospital of Grenoble: A 12-month follow-up of an intravenous ferric carboxymaltose treatment program in a cohort of patients with non-dialysis-dependent chronic kidney disease]. Nephrol Ther. 2019 Apr;15(2):104-109. doi: 10.1016/j.nephro.2018.10.006. Epub 2019 Feb 23. French.
- Results publication: PubMed 36060352Agrawal S, Sonawane S, Kumar S, Acharya S, Gaidhane SA, Wanjari A, Kabra R, Phate N, Ahuja A. Efficacy of Oral Versus Injectable Iron in Patients With Chronic Kidney Disease: A Two-Year Cross-Sectional Study Conducted at a Rural Teaching Hospital. Cureus. 2022 Jul 31;14(7):e27529. doi: 10.7759/cureus.27529. eCollection 2022 Jul.
- Results publication: PubMed 31443557Sieske L, Janssen G, Babel N, Westhoff TH, Wirth R, Pourhassan M. Inflammation, Appetite and Food Intake in Older Hospitalized Patients. Nutrients. 2019 Aug 22;11(9):1986. doi: 10.3390/nu11091986.
- Results publication: PubMed 27827838Petry N, Olofin I, Hurrell RF, Boy E, Wirth JP, Moursi M, Donahue Angel M, Rohner F. The Proportion of Anemia Associated with Iron Deficiency in Low, Medium, and High Human Development Index Countries: A Systematic Analysis of National Surveys. Nutrients. 2016 Nov 2;8(11):693. doi: 10.3390/nu8110693.
- " HAS 2011 - Choix des examens du métabolisme du fer en cas de suspicion de carence martiale - texte long ", s. d.Link provided by the sponsor.
- KIANI et al., " Main nutritional deficiencies ".Link provided by the sponsor.
- " Revue Médicale Suisse 2011 ; 7 : 2018-23 RMS\_idPAS\_D\_ISBN\_pu2011-37s\_sa03\_art03.pdf "Link provided by the sponsor.
- " HAS 2011 - Choix des examens du métabolisme du fer en cas de suspicion de carence martiale - texte long "Link provided by the sponsor.
- World Health Organization, WHO Guideline on Use of Ferritin Concentrations to Assess Iron Status in Individuals and Populations (Geneva: World Health Organization, 2020)Link provided by the sponsor.
- " KDIGO-2012-Anemia-Guideline-English.pdf ", consulté le 24 novembre 2024Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexis BOCQUET, Hospital Doctor principal investigator
University Hospital, Grenoble Alpes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia and Inflammation, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bruna DUCOTTERD, Clinical Research Associate (+33 4 76 76 78 38, bducotterd@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean increase in hemoglobin (time frame: At 3 months (end of study)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07014436, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025; AzTrials last refreshed its copy on 1 Nov 2026.