FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2026/02/104218 [Registered on: 18/02/2026] Trial Registered Prospectively
Last Modified On: 18/02/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Preventive
Screening 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A study to compare different daily doses of iron and folic acid supplements for improving anaemia among adolescent girls in Telangana 
Scientific Title of Study   Relative Efficacy of Different Doses of Iron (45mg, 60mg, and 120mg) Along with Folic Acid (500mcg) Supplementation in Improving Iron Status and Long-term Effects Among Adolescent Girls: A Randomized Controlled Trial in Mahbubnagar, Telangana 
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 C S SURYA GOUD 
Designation  Scientist C ( Medical) 
Affiliation  ICMR-National Institute Of Nutrition 
Address  Room No 101, Gopalan Block, Ground Floor, Department of Public Health Nutrition Beside Tarnaka Metro Station Hyderabad Telangana

Hyderabad
TELANGANA
500007
India 
Phone    
Fax    
Email  suryagoud.cs@icmr.gov.in  
 
Details of Contact Person
Scientific Query
 
Name  DR C S SURYA GOUD 
Designation  Scientist C ( Medical) 
Affiliation  ICMR-National Institute Of Nutrition 
Address  Room No. 101, Gopalan Block, Ground Floor, Department of Public Health Nutrition, Beside Tarnaka Metro Station, Hyderabad, Telangana 500007, India.

Hyderabad
TELANGANA
500007
India 
Phone    
Fax    
Email  suryagoud.cs@icmr.gov.in  
 
Details of Contact Person
Public Query
 
Name  DR C S SURYA GOUD 
Designation  Scientist C ( Medical) 
Affiliation  ICMR-National Institute Of Nutrition 
Address  Room No. 101, Gopalan Block, Ground Floor, Department of Public Health Nutrition,Beside Tarnaka Metro Station, Hyderabad, Telangana 500007, India.


TELANGANA
500007
India 
Phone    
Fax    
Email  suryagoud.cs@icmr.gov.in  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  ICMR 
Address  V. Ramalingaswami Bhawan, P.O. Box No. 4911Ansari Nagar, New Delhi - 110029, India Phone: 91-11-26588895 / 91-11-26588980 Fax: 91-11-26588662 Email: icmrhqds@sansad.nic.in 
Type of Sponsor  Research institution 
 
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 C S SURYA GOUD  ICMR-National Institute of Nutrition  Room No. 101, Gopalan Block, Ground Floor, Department of Public Health Nutrition, Beside Tarnaka Metro Station, Hyderabad, Telangana 500007, India.
Hyderabad
TELANGANA 
9581515390

suryagoud.cs@icmr.gov.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,ICMR-NIN   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  Low-dose Iron + Folic Acid supplementation  Low-dose Iron + Folic Acid supplementation 
Intervention  Moderate-dose Iron + Folic Acid supplementation  Participants will receive oral supplementation with 60 mg elemental iron (as ferrous sulfate) along with 500 µg folic acid once daily for 90 days. The tablets will be administered under supervision in the morning (between 8:00–9:00 AM) along with breakfast. Adherence will be ensured through supervised administration by trained hostel or project staff. 
Comparator Agent  Standard-dose Iron + Folic Acid supplementation  Participants will receive oral supplementation with 120 mg elemental iron (as ferrous sulfate) along with 500 µg folic acid once daily for 90 days. The tablets will be administered under supervision in the morning (between 8:00–9:00 AM) along with breakfast. This arm represents the standard therapeutic dose used for treatment of mild to moderate anaemia. 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  19.00 Year(s)
Gender  Female 
Details  Female adolescents aged 12 to 19 years

Mild to moderate anaemia is defined as hemoglobin 8.0–11.4 g per dL at baseline

Resident of selected government residential hostels

Residing in the hostel for at least 6 months before enrolment

Likely to remain in the hostel for the duration of the intervention and follow-up

Willing to participate and provide written informed consent greater than or equal to 18 years) or parental consent with adolescent assent (less than 18 years 
 
ExclusionCriteria 
Details  Severe anaemia (hemoglobin less than 8.0 g per dL) requiring immediate medical treatment

Known hemoglobinopathies (e.g., sickle cell disease, thalassemia)

Chronic inflammatory or systemic illnesses

Disorders affecting iron absorption

Current or recent (within the last 3 months) iron supplementation or anaemia treatment

Known hypersensitivity to iron or folic acid

Pregnant or lactating adolescents

Any condition that, in the opinion of the investigator, may interfere with study participation 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Mean change in hemoglobin concentration (g per dL)  base line to 90 days  
 
Secondary Outcome  
Outcome  TimePoints 
Change in iron status biomarkers (serum ferritin, transferrin saturation, soluble transferrin receptor, serum hepcidin)  Baseline, 90 days, and 365 days 
Proportion of participants achieving hemoglobin greater than 12.0 g per dL  90 days and 365 days 
Frequency and severity of gastrointestinal adverse effects (nausea, vomiting, constipation, diarrhea)  During the 90-day intervention period 
Association between menstrual blood loss (PBAC score) and hemoglobin response  Baseline and 90 days 
 
Target Sample Size   Total Sample Size="450"
Sample Size from India="450" 
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 2/ Phase 3 
Date of First Enrollment (India)   03/08/2026 
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="2"
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  

Anaemia due to iron deficiency is a major public health problem among adolescent girls in India despite long standing supplementation programs. The standard therapeutic dose of oral iron used for treatment of mild to moderate anaemia is relatively high and is often associated with gastrointestinal side effects which may reduce adherence. Evidence from recent studies suggests that lower doses of iron may be equally effective in improving haemoglobin levels but data on their effect on body iron status and long term sustainability are limited in Indian adolescents.

This study is a cluster randomised controlled trial conducted among adolescent girls aged 12 to 19 years residing in government residential hostels in Mahabubnagar district of Telangana. The trial will compare the relative efficacy of three daily doses of elemental iron 45 mg 60 mg and 120 mg each given with folic acid for a period of 90 days. Hostels will be used as the unit of randomisation to minimise contamination and to enable supervised administration of supplements.

The primary objective of the study is to evaluate whether lower doses of iron are not inferior to the standard higher dose in improving haemoglobin levels at 90 days. Secondary objectives include assessment of changes in iron status indicators gastrointestinal tolerability and sustainability of treatment effects at one year follow up. The study also aims to examine the association between menstrual blood loss and response to iron supplementation. The findings are expected to provide evidence to inform optimal iron dosing strategies for anaemia control programmes targeting adolescent girls.

 
Close