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CTRI Number  CTRI/2025/03/081855 [Registered on: 06/03/2025] Trial Registered Prospectively
Last Modified On: 19/02/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Study to find how effective and safe are different dosages of iron supplements among women with Iron deficiency anaemia. 
Scientific Title of Study   Randomized controlled trial to evaluate the efficacy and safety of Oral Iron regimens differing in frequency among anaemic women of Coastal Karnataka. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Amit Kumar Rao 
Designation  Assistant Professor  
Affiliation  K S Hegde Medical Academy 
Address  Department of Community Medicine, K S Hegde Medical Academy, Nitte DU, Nithyananda Nagar, Dakshina Kannada district

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9739864337  
Fax    
Email  dramit.kumar@nitte.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Amit Kumar Rao 
Designation  Assistant Professor  
Affiliation  K S Hegde Medical Academy 
Address  Department of Community Medicine, K S Hegde Medical Academy, Nitte DU, Nithyananda Nagar, Dakshina Kannada district

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9739864337  
Fax    
Email  dramit.kumar@nitte.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Amit Kumar Rao 
Designation  Assistant Professor  
Affiliation  K S Hegde Medical Academy 
Address  Department of Community Medicine, K S Hegde Medical Academy, Nitte DU, Nithyananda Nagar, Dakshina Kannada district

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9739864337  
Fax    
Email  dramit.kumar@nitte.edu.in  
 
Source of Monetary or Material Support  
K S Hegde MEdical Academy, Nitte Deemed to be University, Deralakatte, Mangalore, Dakshina Kannada district, Karnataka state, India 575018. 
 
Primary Sponsor  
Name  K S Hegde Medical Academy 
Address  Nithyananda Nagar, Deralakatte,Dakshina Kannada district, Karnataka state, India 575018 
Type of Sponsor  Private 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 Amit Kumar Rao  K S Hegde Medical Academy  Department of Community Medicine, Second floor,Nithyananda Nagar, Deralakatte, Dakshina Kannada 575018
Dakshina Kannada
KARNATAKA 		 9739864337

dramit.kumar@nitte.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
K S Hegde Medical Academy  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 
Intervention  Iron and folic acid tablets on daily and alternate day regimens  • Participants will receive oral iron supplements (60 mg elemental iron) according to their assigned regimen for 12 weeks, with data collection during Day 0, Day 28, Day 56, and Day 84, with an interim analysis post-Day 56 to review whether an additional 4 weeks is required for the trial. Group 1 will receive daily iron supplements of 60 mg of elemental iron orally for 12 weeks. Group 2 will receive an alternate-day iron supplements of 60 mg elemental iron orally for 12 weeks. On other alternate days, they will receive placebo. 
Comparator Agent  Placebo for second arm with alternate day Iron supplementation  For participants in the second arm with alternate-day Iron tablets, the other days will include placebo to ensure allocation concealment 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  49.00 Year(s)
Gender  Female 
Details  All women aged 18-49 years with haemoglobin levels less than 12 g/dl. 
 
ExclusionCriteria 
Details  regnant women, Hb less than 8 g/dl, Sickle cell anaemia, thalassaemia and other haemoglobinopathies 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in heamoglobin levels from baseline and day 84.  At baseline and on day 84 after the start of intervention. 
 
Secondary Outcome  
Outcome  TimePoints 
Change in serum ferritin levels, incidence of gastrointestinal symptoms, & compliance.  At baseline, 28 days, 56 days &and 84 days from start of intervention 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   14/04/2025 
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="0"
Months="6"
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 - NO
Brief Summary   We have obtained IEC approval for the study and are in the process of procuring materials and manpower required for the conduction of the study. The recruitment will begin from 10th March 2025 and the same will be updated on the CTRI website. 
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