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CTRI Number  CTRI/2025/07/091924 [Registered on: 28/07/2025] Trial Registered Prospectively
Last Modified On: 03/06/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Cluster Randomized Trial 
Public Title of Study   Daily versus alternate day oral iron therapy in children with iron deficiency anaemia 
Scientific Title of Study
Modification(s)  		 Daily versus alternate day oral iron supplementation in children between 6-59 months age with iron deficiency anaemia: Randomized controlled multi-centric study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sanjeev Khera 
Designation  Professor  
Affiliation  Command Hospital Pune 
Address  Department of Paediatrics Command Hospital Pune Pune-411040 (Mah)

Pune
MAHARASHTRA
411040
India 
Phone  8192954481  
Fax    
Email  Kherakherakhera@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sanjeev Khera 
Designation  Professor  
Affiliation  Command Hospital Pune 
Address  Department of Paediatrics Command Hospital Pune Pune-411040 (Mah)

Pune
MAHARASHTRA
411040
India 
Phone  8192954481  
Fax    
Email  Kherakherakhera@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sanjeev Khera 
Designation  Professor  
Affiliation  Command Hospital Pune 
Address  Department of Paediatrics Command Hospital Pune Pune-411040 (Mah)

Pune
MAHARASHTRA
411040
India 
Phone  8192954481  
Fax    
Email  Kherakherakhera@gmail.com  
 
Source of Monetary or Material Support  
O/o Director General Armed Forces Medical Services 
 
Primary Sponsor  
Name  O/o Director General Armed Forces Medical Services 
Address  Block-A, 4th Floor Africa Avenue New Delhi-110023 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Safal Muhammed  Army Hospital Research & Referral  Department of Paediatrics Army Hospital R&R New Delhi-110010
New Delhi
DELHI 		 8411042521

safalmk86@gmail.com 
Ruchika Jha  Base Hospital Delhi Cantt  Department of Paediatrics Base Hospital Delhi Cantt New Delhi-110010
New Delhi
DELHI 		 9556875994

ruchicls@yahoo.com 
Barnali Mitra  Command Hospital Chandimandir  Department of Paediatrics Command Hospital Chandimandir Panchkula-134114 (Har)
Panchkula
HARYANA 		 8811851826

7barnali@gmail.com 
Sweta Mukherjee  Command Hospital Lucknow  Department of Paediatrics Command Hospital Lucknow Sadar Bazar Lucknow-226002 Pune-411040 (Mah)
Lucknow
UTTAR PRADESH 		 9830032814

sweta2avantika@gmail.com 
Sanjeev Khera  Command Hospital Pune  Department of Paediatrics Command Hospital Pune Pune-411040 (Mah)
Pune
MAHARASHTRA 		 08192954481

Kherakherakhera@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
IEC Command Hospital Lucknow  Approved 
IEC Armed Forces Medical College  Approved 
IEC Army Hospital R R Delhi Cantt  Approved 
IEC Base Hospital Delhi Cantt  Approved 
IEC Command Hospital Chandimandir  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D509||Iron deficiency anemia, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Syp Colloidal iron (80mg/5ml elemental iron) with RDA of Folic Acid (200 microgm) and B12 (2 microgm)   Syp Colloidal iron (80mg/5ml elemental iron) with RDA of Folic Acid (200 microgm) and B12 (2 microgm) once daily for 3 months at dose 3mg/kg/day  
Intervention  Syp Colloidal iron (80mg/5ml elemental iron) with RDA of Folic Acid (200 microgm) and B12 (2 microgm)   Syp Colloidal iron (80mg/5ml elemental iron) with RDA of Folic Acid (200 microgm) and B12 (2 microgm) once on alternate day for 6 months at dose 3mg/kg/dose  
 
Inclusion Criteria  
Age From  6.00 Month(s)
Age To  59.00 Month(s)
Gender  Both 
Details  Children between 6 to 59 months age with mild to moderate anaemia as defined by WHO and with serum ferritin less than 30 ng/ml attending OPD  
 
ExclusionCriteria 
Details  Children with thalassemia trait, syndromic children, children with physical, cognitive & mental disability, children with chronic illnesses, severely malnourished children and children who have received a blood transfusion 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Prevalence of iron deficiency anaemia   At 3 months and 6 months post start of oral iron therapy in two arms 
 
Secondary Outcome  
Outcome  TimePoints 
Comparison of haemoglobin, serum ferritin, serum iron studies and serum hepcidin at baseline, three month and six month in both arms  Baseline, 3 month and 6 month 
Comparison of gastrointestinal side-effect profile of oral iron noted weekly in two arms  at 3 month and 6 month 
 
Target Sample Size   Total Sample Size="446"
Sample Size from India="446" 
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 
Date of First Enrollment (India)   15/08/2025 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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   Primary purpose of this randomized controlled multi-centric trial is comparison of two dose frequency of oral iron therapy in children between 6 to 59 month age with iron deficiency anaemia. One arm will receive daily oral iron for 3 months and another arm will receive alternate day oral iron for 6 months. This will help in dose equivalence of oral iron in two groups. The study hypothesis is that alternate day oral iron therapy in children with iron deficiency anaemia is more effective compared to daily oral iron therapy. Children between 6 to 59 months age with mild to moderate iron deficiency anaemia IDA) as defined by WHO and with serum ferritin less than 30 ng/ml attending OPD  will be included. Children with thalassemia trait, syndromic children, children with physical, cognitive & mental disability, children with chronic illnesses, severely malnourished children  and children who have received a blood transfusion will be excluded. Children fulfilling inclusion criteria will be enrolled after due consent from parents. A single 5-7 ml venous blood sample will be taken for investigations at three time points, at baseline, after 3 months and after 6 months.  The laboratory tests which will be conducted at all three timepoints: CBC, serum ferritin, CRP, serum iron studies and serum hepcidin. Sample for Hb-HPLC or Hb electrophoresis before enrolment to study (as part of baseline sampling) will be taken to exclude children with thalassemia. Sample at 03 months and 06 months will be taken after 03 days of stopping Iron therapy to avoid hepcidin surge post oral iron therapy. Sample processing will be done in pathological laboratories in situ. Sample for serum hepcidin will be stored at  minus 20 degree C and transported to nodal centre for processing in batches. All enrolled children more than 12 months of age will receive one dose of albendazole (to ensure deworming) before starting oral iron. Control arm will receive 3mg/kg/day of oral iron (Preparation Colloidal iron 80 mg/5 ml elemental iron with RDA of Folic acid (200 µg) and B12 (2 µg) as once daily dose for three months. Iron syp of same batch will be procured and distributed to all the participating centres. Experimental arm will receive 3mg/kg of oral iron as OD dose on alternate days for a total for 6 months. Primary outcome will be prevalence of IDA at end of oral iron therapy in two arms. Secondary outcome will be comparison of Hb, serum ferritin, serum iron studies and serum hepcidin at baseline, at three months and at 6 months. Research fellows will be trained before enrolment with respect to data collection. Compliance will be ensured and marked and GI side-effect profile will be noted by research fellows using telephonic calls on weekly basis. Children experiencing pain abdomen, diarrhoea, dyspepsia and vomiting greater than grade 3 as per common terminology criteria for adverse events (CTCAE) will be taken out of study. Data will be collected in excel sheet and analyzed using suitable statistical tests.



 
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