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

NCT07014436 | Not Yet Recruiting

• 1 other identifier: 38RC25.0094
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Anemia; Inflammation

Keywords

cohort; anemia; inflammation; prospective; iron supplementation

Outcome Measures

Primary Outcomes (1)

• 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)).

  At 3 months (end of study)

Secondary Outcomes (3)

• Correction of anemia :

  At 3 months (end of study)

• Identify factors associated with anemia correction

  At 3 months (end of study)

• Adverse events :

  At 3 months (end of study)

Study Arms (2)

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%.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

University Hospital, Grenoble Alpes

La Tronche, 38700, France

Location

Related Publications (7)

• 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.

  PMID: 34693519 BACKGROUND

• Kiani 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.

  PMID: 36479498 BACKGROUND

• Shepshelovich 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.

  PMID: 27321965 RESULT

• Romanet 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.

  PMID: 30803900 RESULT

• Agrawal 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.

  PMID: 36060352 RESULT

• Sieske 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.

  PMID: 31443557 RESULT

• Petry 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.

  PMID: 27827838 RESULT

Related Links

• " HAS 2011 - Choix des examens du métabolisme du fer en cas de suspicion de carence martiale - texte long ", s. d.
• KIANI et al., " Main nutritional deficiencies ".
• " Revue Médicale Suisse 2011 ; 7 : 2018-23 RMS\_idPAS\_D\_ISBN\_pu2011-37s\_sa03\_art03.pdf "
• " HAS 2011 - Choix des examens du métabolisme du fer en cas de suspicion de carence martiale - texte long "
• World Health Organization, WHO Guideline on Use of Ferritin Concentrations to Assess Iron Status in Individuals and Populations (Geneva: World Health Organization, 2020)
• Aurelien Amiot et al., " Practice guidelines for the diagnosis and management of ulcerative colitis " 29 (2022).
• " KDIGO-2012-Anemia-Guideline-English.pdf ", consulté le 24 novembre 2024
• " 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure \| Journal de Cardiologie "
• "ANSM 1997 - Hémogramme "

MeSH Terms

Conditions

Anemia; Inflammation

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alexis BOCQUET, Hospital Doctor

  University Hospital, Grenoble Alpes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bruna DUCOTTERD, Clinical Research Associate

CONTACT

+33 4 76 76 78 38; bducotterd@chu-grenoble.fr

Study Design

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

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: June 11, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 11, 2025

Record last verified: 2025-06

Locations

FR (1)