Status:
COMPLETED
Ferric Carboxymaltose Methemoglobinemia Study
Lead Sponsor:
Ordu University
Collaborating Sponsors:
Marmara University Pendik Training and Research Hospital
Conditions:
Methemoglobinemia
Anemia, Iron-Deficiency
Eligibility:
All Genders
18+ years
Brief Summary
Anemia that develops due to iron deficiency is called iron deficiency anemia. This common condition is treated with iron supplements taken either orally or given through an intravenous (IV) infusion. ...
Detailed Description
Methemoglobinemia, which results from the conversion of ferrous iron (Fe2+) to ferric iron (Fe3+) in hemoglobin (Hb), is a potentially life-threatening disorder resulting in functional anemia due to r...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- FCM Group:
- Adults (≥18 years)
- Presence of anemia (Hb \<12 g/dl in women, \<13 g/dl in men)
- Low ferritin (\<30 mcg/l)
- Patients for whom FCM administration has been decided in routine medical care practice
- Control Group:
- Healthy adult (≥18 years) individuals who applied to the internal medicine outpatient clinic, who had no current or pre-existing chronic disease, who did not have anemia and iron deficiency (ferritin ≥30 mcg/L).
- EXCLUSION CRITERIA:
- Known methemoglobinemia-related diseases (Hb M disease, cytochrome b5 reductase deficiency, etc.)
- Use of drugs associated with methemoglobinemia (acetylsalicylic acid, dapsone, chloroquine, metoclopramide, benzocaine, lidocaine, prilocaine, rasburicase, primaquine, sulfonamide, nitric oxide)
- Those with B12 and/or folate deficiency
- Those with Charlson Comorbidity Index ≥3
- Presence of advanced organ failure (Stage 4 and 5 chronic kidney disease, Child C cirrhosis, NYHA class 3 and 4 chronic heart failure, respiratory failure requiring oxygen supplementation and similar processes)
- Presence of malignancy (with or without cure)
- Presence of active infection (CRP \> 5 mg/dL) and/or other acute disorder/disease
- Pregnancy status
Exclusion
Key Trial Info
Start Date :
April 14 2025
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 30 2025
Estimated Enrollment :
977 Patients enrolled
Trial Details
Trial ID
NCT06958822
Start Date
April 14 2025
End Date
September 30 2025
Last Update
November 19 2025
Active Locations (23)
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1
University of Health Sciences Adana City Health Application and Research Center
Adana, Adana, Turkey (Türkiye), 01100
2
Akdeniz University Hospital
Konyaalti, Antalya, Turkey (Türkiye), 07070
3
Balıkesir University Health Practice and Research Hospital
Merkez, Balıkesir, Turkey (Türkiye), 10145
4
Bursa City Hospital
Nilufer, Bursa, Turkey (Türkiye), 16110