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CTRI Number  CTRI/2026/02/103311 [Registered on: 09/02/2026] Trial Registered Prospectively
Last Modified On: 07/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of two low-dose oral iron preparations for treatment of iron deficiency anemia 
Scientific Title of Study   Low-dose oral ferrous sulphate versus ferrous fumarate for treatment of iron deficiency anaemia: An open label randomized controlled trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vinod K V 
Designation  Professor 
Affiliation  JIPMER 
Address  Department of General Medicine JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry - 605006.
JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry - 605006.
Pondicherry
PONDICHERRY
605006
India 
Phone  04132296233  
Fax    
Email  drkvv@rediffmail.com  
 
Details of Contact Person
Scientific Query  
Name  Vinod K V 
Designation  Professor 
Affiliation  JIPMER 
Address  Department of General Medicine JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry - 605006.
JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry - 605006.
Pondicherry
PONDICHERRY
605006
India 
Phone  04132296233  
Fax    
Email  drkvv@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Vinod K V 
Designation  Professor 
Affiliation  JIPMER 
Address  Department of General Medicine JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry - 605006.
JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry - 605006.
Pondicherry
PONDICHERRY
605006
India 
Phone  04132296233  
Fax    
Email  drkvv@rediffmail.com  
 
Source of Monetary or Material Support  
Jawaharlal Institute of Postgraduate Medical Education and Research JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry - 605006, India. 
 
Primary Sponsor  
Name  JIPMER, Puducherry 
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 
Dr Vinod K V  Jawaharlal Institute of Postgraduate Medical Education and Research  JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry - 605006, India.
Pondicherry
PONDICHERRY 		 04132296233

drkvv@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE - INTERVENTIONAL STUDIES, JIPMER  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D50||Iron deficiency anemia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ferrous fumarate  Ferrous fumarate 200mg Once Daily 
Comparator Agent  Ferrous sulphate  Ferrous sulphate 200 mg Once Daily 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Newly diagnosed patients with iron deficiency anemia of either sex
Iron deficiency anemia is defined as Hemoglobin concentration between 6-10g/dl, serum ferritin concentration of less than 30 microgram/L and peripheral blood picture consistent with iron deficiency anemia
 
 
ExclusionCriteria 
Details  Patients with iron deficiency anemia with cardiac failure
Pregnant and lactating women
Patient who has already been diagnosed to have iron deficiency anemia and receiving oral iron therapy
Patients requiring urgent blood transfusion for anemia
Patients with known allergy to ferrous sulphate or ferrous fumarate
Patients known to have thalassemia
Patients known to have malabsorption syndrome
Patients known to have peptic ulcer disease
Patients known to have coronary artery disease
Patients known to have chronic kidney disease with serum creatinine of more than 2mg/dL
Patients known to have liver disease
Alcohol abuse with Alcohol intake of more than once per week
Overt Gastrointestinal bleeding
Patient who received acid suppressive therapy for more than 1 month
Dimorphic or Megaloblastic picture on peripheral smear examination
Patients known to have Anemia of chronic disease secondary to systemic lupus erethematousus, inflammatory bowel disease, HIV, Tuberculosis 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare the haemoglobin increment with low-dose ferrous sulphate (once daily 200 mg tablet, with 60mg elemental iron) and ferrous fumarate (once daily 200 mg tablet with 64mg elemental iron) treatments  4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Assessing the adverse effects related to low-dose ferrous sulphate and ferrous fumarate treatments
Assessing the treatment compliance between the two arms 		 2 weeks, 4 weeks, 8 weeks and 12 weeks 
To compare the haemoglobin increment with low-dose ferrous sulphate and ferrous fumarate treatments  2 weeks, 8 weeks and 12 weeks 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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   Phase 3/ Phase 4 
Date of First Enrollment (India)   23/02/2026 
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 Applicable 
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 - NO
Brief Summary   This study is a randomized, open label, parallel group, single centre trial comparing the safety and efficacy of Ferrous sulphate 200 mg daily and Ferrous fumarate 200 mg daily for 3 months in 100 patients with iron deficiency anemia . The primary outcome is the haemoglobin increment  at 4 weeks (from baseline) in the two arms. The secondary outcomes will be adverse effects related to treatment, treatment compliance and hemoglobin increments at weeks-2,8 and 12 in the two arms. 
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