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

Recruiting

• Conditions: Other iron deficiency anemias,

• Registration Number: CTRI/2022/12/048152
• Lead Sponsor: Subhashree Kar

Brief Summary

All recruited patients will be randomly divided into two groups of Group-A and Group-B. Group-A will receive intravenous Ferric carboxymaltose and Group-B will receive iv Iron sucrose as per their clinical need.

Following routine lab investigations will be done before the treatment begins: CBC (complete blood count), serum iron level, TIBC, TSAT and Serum Ferritin level.

The treatment regimen will be calculated by using the GANZONI formula – Total iron dose= [actual body weight(target Hb – actual Hb)]\* 2.4 + iron stores. FCM will be administered in single, once weekly infusions of 1000mg or 500mg iron over at least 15mins duration. Iron sucrose 200-500mg in NS 200ml will be administered slow iv over 3 hours and may be repeated to reach maximum 1gm.

Both the groups A and B will have laboratory investigations done at 2 weeks, 4weeks and 12 weeks and again at 6 months interval to evaluate the changes in Hb level and other baseline characteristics pre and post treatment to see the efficacy of both the drugs in the IDA patients.  The adverse reactions if any in both the groups will be recorded in ADR forms generated by IPC (Indian Pharmacopoeia Commission version 1.4). Causality and severity assessment will be done by using WHO-UMC Scale and Modified Hartwig Seigel scale. Quality of life will be assessed by SF-36 questionnaire.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-20
• Last Update Posted: 2023-09-25

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 100

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

1.Age<18 years 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
quality of life assesment using SF36 questionnaire	At 4 weeks and 12 weeks interval from the start of the treatment

Trial Locations

Locations (1)

SCB MEDICAL COLLEGE AND HOSPITAL, CUTTACK 753007; 🇮🇳 Cuttack, ORISSA, India

SCB MEDICAL COLLEGE AND HOSPITAL, CUTTACK 753007

🇮🇳Cuttack, ORISSA, India

Subhashree Kar

Principal investigator

7681851840

kar.subhashree1502@gmail.com