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CTRI Number  CTRI/2022/11/047607 [Registered on: 24/11/2022] Trial Registered Prospectively
Last Modified On: 05/01/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Iron Deficiency Anemia, Intravenous Iron Treatment 
Scientific Title of Study   Intravenous Ferric Carboxymaltose vs Intravenous Iron Sucrose in Iron Deficiency Anemia – A Randomized Controlled Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SUMANTH H S 
Designation  JUNIOR RESIDENT  
Affiliation  JIPMER 
Address  3rd floor, Old Block, Medicine Department, JIPMER, Jipmer campus road, Dhanvantari Nagar, Puducherry, 605006

Pondicherry
PONDICHERRY
605006
India 
Phone  8792388531  
Fax    
Email  sumanthhs505@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr K BALAMURUGESAN 
Designation  ADDITIONAL PROFESSOR 
Affiliation  JIPMER 
Address  3rd floor, Medicine Department, JIPMER, Jipmer campus road, Dhanvantari Nagar, Puducherry, 605006
3rd floor, Medicine Department, JIPMER, Jipmer campus road, Dhanvantari Nagar, Puducherry, 605006
Pondicherry
PONDICHERRY
605006
India 
Phone  8012344492  
Fax    
Email  pkbala77@gmail.com  
 
Details of Contact Person
Public Query  
Name  SUMANTH H S 
Designation  JUNIOR RESIDENT  
Affiliation  JIPMER 
Address  3rd floor, Medicine Department, JIPMER, Jipmer campus road, Dhanvantari Nagar, Puducherry, 605006

Pondicherry
PONDICHERRY
605006
India 
Phone  8792388531  
Fax    
Email  sumanthhs505@gmail.com  
 
Source of Monetary or Material Support  
JIPMER INTRAMURAL RESEARCH FUND. (IMRF) 
 
Primary Sponsor  
Name  JIPMER 
Address  JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry, 605006. 
Type of Sponsor  Research institution and hospital 
 
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 
SUMANTH H S  JIPMER  3rd floor, Medicine Department, JIPMER, Jipmer campus road, Dhanvantari Nagar, Puducherry, 605006
Pondicherry
PONDICHERRY 		 8792388531

sumanthhs505@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E611||Iron deficiency,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intravenous Ferric Carboxymaltose   Name - Intravenous Ferric carboxymaltose Dose – Maximum 1000mg , Based on Iron Deficit Using Ganzoni Formula Route – Intravenous Frequency – One Dose Duration – One day  
Comparator Agent  Intravenous Iron Sucrose  Name - Intravenous Iron Sucrose Dose – Maximum 1000mg , Based on Iron Deficit Using Ganzoni Formula Route – Intravenous Frequency – one time per day , alternate day 200mg dose Duration – Iron deficit to be given over 5-8 days.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients with Age >18 years who are diagnosed to have iron deficiency anemia, Hb<7g% and admitted in medicine department in JIPMER 
 
ExclusionCriteria 
Details  Exclusion Criteria
1. Pregnant female
2. Previous history of allergic reaction to IV iron preparations
3. Patient having Hb ≥ 7g% Hb.
4. Patients having S. Ferritin more than 30ng/ml with an exception to CKD patients.
5. Any active infections,sepsis
6. Ishchemic heart disease
7. Dimorphic anemia
8. Anemic patients with cardiac failure
9. Past history of blood transfusion within past one month
10. Patient with acute GI bleed or any active bleed
11. CKD with Increased ferritin(>500ng/ml)
12. Thalassemia
13. Not willing to give consent
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
hemoglobin, iron stores (Ferritin).  Baseline,2,4,6th week 
 
Secondary Outcome  
Outcome  TimePoints 
1. To determine the adverse events of both IV preparations.
2. To study the degree of variation in RBC indices at the end of 4,6th weeks. 		 At 4,6th weeks
 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   01/12/2022 
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="2"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Not yet  
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
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 01-08-2021 and end date provided 30-08-2023?
    Response (Others) - 

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

The study will be conducted in JIPMER hospital for 2 years from July 2021 onwards after obtaining IEC approval.  Patients with Age >18 years who are diagnosed to have iron deficiency anemia, Hb<7g% and admitted in medicine department in JIPMER will be included in the study.

Informed consent will be taken from the participants of the study. The process of randomization and allocation shall be explained to the participants.

 
Patients with Hb <7g/dl, MCV < 80fL, S.Ferritin <30ng/ml will be diagnosed as Iron Deficiency Anemia in the study

•      Group A - Receives Intravenous Ferric Carboxymaltose after test dose , 500-1000mg , diluted in 100ml NS over 15 – 30 min infusion with aseptic precautions and will be monitored for any reactions . Maximum dose 1000mg per day or 15mg/kg

 

•      Group B  - Receives Intravenous Iron sucrose after test dose ,freshly prepared iron sucrose will administered as 200 mg elemental iron in 200mL 0·9% sodium chloride infusion over 3-4 hours with all aseptic precautions and will be monitored for any reactions, and given 300mg Iron Sucrose the next day.


        Follow Up

 

 Patients will be called , messaged prior to the 2,4,6th week to come to the hospital for follow ups.

 

Both Groups will be followed up with

Follow-up after 2,4,6 weeks for Hb level and CBC

Follow up after 4,6 weeks for S.Ferritin, Serum iron studies
 
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