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CTRI Number  CTRI/2025/07/091080 [Registered on: 17/07/2025] Trial Registered Prospectively
Last Modified On: 16/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Screening 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Studying the effectiveness of Iron Supplementation in women with Iron Deficiency Anemia  
Scientific Title of Study   Effectiveness of Iron Supplementation on Consecutive Day versus Alternate Day in women with Iron Deficiency Anemia-A Randomized Comparative study  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Manikandan S 
Designation  PG student 
Affiliation  SRM College of Pharmacy 
Address  Department of Pharmacy Practice, SRM College of Pharmacy ,SRMIST, Kattankulathur, Chengalpattu

Kancheepuram
TAMIL NADU
603203
India 
Phone    
Fax    
Email  drmanikandan.in.pharma@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr S Sarumathy 
Designation  Assossiate professor 
Affiliation  SRM College of Pharmacy 
Address  Department of Pharmacy Practice, SRM College of Pharmacy ,SRMIST, Kattankulathur, Chengalpattu

Kancheepuram
TAMIL NADU
603203
India 
Phone    
Fax    
Email  sarumats@srmist.edu.in  
 
Details of Contact Person
Public Query
 
Name  Manikandan S 
Designation  PG student 
Affiliation   
Address  Department of Pharmacy Practice, SRM College of Pharmacy ,SRMIST, Kattankulathur, Chengalpattu

Kancheepuram
TAMIL NADU
603203
India 
Phone    
Fax    
Email  drmanikandan.in.pharma@gmail.com  
 
Source of Monetary or Material Support  
SRM College of Pharmacy, SRMIST, Kattankulathur, Chengalpattu, Tamil Nadu- 603203 
 
Primary Sponsor  
Name  SRM college of pharmacy 
Address  Department of pharmacy practice,SRM College of pharmacy ,SRMIST,Kattankulathur,chengalpattu 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Tamil Nadu Pharmaceutical Sciences Welfare Trust  Tamil Nadu Pharmaceutical Sciences Welfare Trust, 608A, 6th Floor, Phase I, Spencer Plaza, 768/769, Anna Salai, Chennai- 600002 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
MANIKANDAN S  SRM Medical College Hospital and Research Centre  Department of Obstetrics and Gynecology, SRM Medical College Hospital and Research Centre, Kattankulathur, Chengalpattu
Kancheepuram
TAMIL NADU 
8940229574

drmanikandan.in.pharma@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  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  Ferrous Fumarate 156 mg OD with Folic Acid 1500 mcg OD  Group A- Consecutive day administered with Ferrous fumarate 156mg OD and Folic acid 1500 mcg OD, Group B Alternate day administered with Ferrous fumarate 156mg OD and Folic acid 1500 mcg OD  
Comparator Agent  Folic acid 1500 mcg OD  Group A- Consecutive day administered with Ferrous fumarate 156mg OD and Folic acid 1500 mcg OD, Group B Alternate day administered with Ferrous fumarate 156mg OD and Folic acid 1500 mcg OD  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  ➢Healthy women aged between 18-45 years with depleted iron stores (serum ferritin 25 ug/L or less) and haemoglobin levels (7-10.9 g/dl).
➢ Women with normal Body mass index (since overweight or obese women
have sub clinical inflammation)
➢ Should not have donated blood or plasma donations in previous 4 months.
➢ Should not be on any medications that may interfere with iron absorption
within two weeks of the study start.
 
 
ExclusionCriteria 
Details  1. Women not willing to give the informed consent
2. Ferritin level > 40 ug/L
3. Any other chronic illness
4. Other causes of anaemic illness like Enlarged spleen (splenomegaly), Hemolysis, Porphyria., Sickle Cell Anaemia, Thalassemia 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess whether alternate-day administration of iron supplement increases iron
absorption compared to consecutive-day iron administration.
 
At the end of 1st, 2nd and 3rd months 
 
Secondary Outcome  
Outcome  TimePoints 
To assess for the safety/tolerability of the iron supplementation in both the study
groups. 
Correlate iron absorption with serum iron and iron status parameters at the end of the 1st, 2nd and 3rd months 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   01/08/2025 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

In iron-depleted women without anemia, oral iron supplements induce an increase in serum hepcidin (SHep) that persists for 24 hours, decreasing iron absorption from supplements given later on the same or next day. Consequently, iron absorption from supplements is highest if iron is given on alternate days.

Whether this dosing schedule is also beneficial in women with iron-deficiency anemia (IDA) given high-dose iron supplements is uncertain.

The primary objective of this study was to assess whether, in women with IDA, alternate-day administration on same dose iron increases iron absorption compared to consecutive-day iron administration.

Secondary objectives were to correlate iron absorption with SHep and iron status parameters. We performing an interventional study iron absorption in women with IDA (n=60) median hemoglobin 11.5 mg/dL, who received alternate days of ferrous sulfate given at 8 AM on days 2, 4 and 6 untill day 30 labeled with stable iron isotopes 57Fe, 58Fe and 54Fe; after a third-month incorporation period,.

 Iron absorption on consecutive days  and alternate days was assessed by measuring erythrocyte isotope incorporation. For both doses, SHep was higher on alternate days In iron-depleted women, providing iron supplements daily as divided doses increases serum hepcidin and reduces iron absorption.

Providing iron supplements on alternate days and in single doses optimizes iron absorption and might be a preferable dosing regimen. These findings should be confirmed in iron-deficient anaemic patients.

 

 
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