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Intravenous Ferric carboxy maltose in the treatment of severe iron deficiency anaemia patients

COMPARATIVE EVALUATION OF EFFICACY AND SAFETY PROFILE OF INTRAVENOUS FERRIC CARBOXYMALTOSE VERSUS IRON SUCROSE IN ADULT PATIENTS WITH SEVERE IRON DEFICIENCY ANAEMIA

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/12/048152
Enrollment
100
Registered
2022-12-15
Start date
Unknown
Completion date
Unknown
Last updated
2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: D508- Other iron deficiency anemias

Interventions

Intervention1: INTRA VENOUS FERRIC CARBOXY MALTOSE: IV Ferric carboxy maltose(FCM) is a third generation parenteral iron preparation designed to overcome the limitations of existing parenteral iron pr

Sponsors

Subhashree Kar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Age 18 years and above of either sex. 2.All diagnosed patients of severe IDA, attending Clinical Haematology & Medicine Department of SCB Medical College and Hospital, Cuttack. 3.TSAT Levels less than 30% 4.He/She must be willing to comply to study protocol till the end of the trial. 5.He/She is willing to give written informed consent at the baseline visit. 6.All patients will be provided with patient information sheet regarding all pros and cons of the study at the baseline visit.

Exclusion criteria

Exclusion criteria: 1.Age 2.Pregnant and Lactating women 3.Anemia due to any other cause other than IDA 4.Patients with known history of hypersensitivity to iv Iron injection 5.Patients with iron treatment or blood transfusion within 4weeks prior to treatment 6.Patients with recent history of treatment with Erythropoetin.

Design outcomes

Primary

MeasureTime frame
1.Efficacy of FCM in comparison to iv Iron sucrose in treating IDA using laboratory assays between two groups A and B. 2.% Change in Hb, Serum Ferritin levels and Transferrin saturation levels 3.Assessing SAFETY PROFILE of FCM in comparision to iv iron sucrose.Timepoint: 1. At baseline visit, 2weeks, 4weeks and 12weeks interval.

Secondary

MeasureTime frame
quality of life assesment using SF36 questionnaireTimepoint: At 4 weeks and 12 weeks interval from the start of the treatment

Countries

India

Contacts

Public ContactTrupti Rekha Swain

SCB Medical College and Hospital, Cuttack

drtruptiswain@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026