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CTRI Number  CTRI/2024/07/071219 [Registered on: 24/07/2024] Trial Registered Prospectively
Last Modified On: 27/06/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Using a intravenous Iron formulation for treating anemia due to iron deficiency 
Scientific Title of Study   Safety, efficacy, cost analysis and acceptability of Intravenous Ferric Carboxymaltose for treatment of Iron deficiency anemia in a tertiary care centre  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rituparna Chetia 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences (AIIMS),Guwahati 
Address  Department of Medical Oncology/Hematology,AIIMS Guwahati,Changsari

Kamrup
ASSAM
781101
India 
Phone  8800322804  
Fax    
Email  rituparnachetia@aiimsguwahati.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Rituparna Chetia 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences (AIIMS),Guwahati 
Address  Department of Medical Oncology/Hematology,AIIMS Guwahati,Changsari


ASSAM
781101
India 
Phone  8800322804  
Fax    
Email  rituparnachetia@aiimsguwahati.ac.in  
 
Details of Contact Person
Public Query  
Name  Rituparna Chetia 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences (AIIMS),Guwahati 
Address  Department of Medical Oncology/Hematology,AIIMS Guwahati,Changsari


ASSAM
781101
India 
Phone  8800322804  
Fax    
Email  rituparnachetia@aiimsguwahati.ac.in  
 
Source of Monetary or Material Support  
AIIMS Guwahati 
 
Primary Sponsor  
Name  AIIMS Guwahati 
Address  Changsari, District-Kamrup, Pin-781101,Assam 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rituparna Chetia  Room no 1089,Department of Medical Oncology/Hematology,OPD Block,AIIMS Guwahati  Changsari District-Kamrup Pin-781101,Assam
Kamrup
ASSAM 		 8800322804

rituparnachetia@aiimsguwahati.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,All India Institute of Medical Sciences(AIIMS),Guwahati  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D500||Iron deficiency anemia secondary to blood loss (chronic), (2) ICD-10 Condition: D508||Other iron deficiency anemias,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Injection Ferric Carboxymaltose  We will be studying the safety,efficacy,cost analysis and acceptability of Intravenous Ferric Carboxymaltose for treatment of Iron deficiency anemia.It is already an approved drug for treatment of the condition and routinely used in day to day practice 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. All patients ≥ 18 years of age with confirmed diagnosis of Iron deficiency anemia
2. Those who have given consent
 
 
ExclusionCriteria 
Details  1. Patients with previous history of hypersensitivity reaction to any of the parenteral iron products
2. Pregnant females
3. Patients with concurrent Vitamin B12 deficiency
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Cost analysis of Intravenous Ferric Carboxymaltose for treatment of Iron deficiency anemia in a tertiary care centre   Data collection at 2 time points:
1) At the time of diagnosis
2) Assessment of therapeutic response 1 month after the first dose of Injection Ferric Carboxymaltose  
 
Secondary Outcome  
Outcome  TimePoints 
Safety, efficacy and acceptability of Intravenous Ferric Carboxymaltose for treatment of Iron deficiency anemia in a tertiary care centre   Data collection at 2 time points:
1) At the time of diagnosis
2) Assessment of therapeutic response 1 month after the first dose of Injection Ferric Carboxymaltose  
 
Target Sample Size   Total Sample Size="57"
Sample Size from India="57" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/08/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [rituparnachetia@aiimsguwahati.ac.in].

  6. For how long will this data be available start date provided 01-08-2024 and end date provided 31-07-2029?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Iron deficiency remains the leading cause of anemia worldwide with significant negative impact on health.Iron repletion options available are oral and  Intravenous(IV) formulations.Though oral iron is considered the first line of therapy for treatment of Iron deficiency anemia(IDA) due to its low cost,good safety profile and ease of administration it’s absorption is affected by several factors and incidence of gastrointestinal side effects can lead to lack of adherence to therapy and poor efficacy.This has led to emergence of intravenous iron therapy which is clearly superior to oral iron with higher increment of hemoglobin levels and rapid replenishment of iron stores.Ferric Carboxymaltose (FCM) is a novel non dextran intravenous iron form which has been approved for patients with iron deficiency who have had inadequate response to oral iron therapy,intolerance to oral iron or non dialysis dependent chronic kidney disease.The safety and efficacy of using FCM in treatment of iron deficiency anemia has been demonstrated in several clinical trials.It has been shown to be non inferior to other intravenous iron formulations with a good safety profile.In spite of it’s efficacy it has been seen that FCM’s acceptability is low and use is limited. No such study has been done in this part of the country.It is not supplied under any national programme. The project aims to quantify efficacy and cost to study its feasibility and find reasons for it’s low acceptability. 
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