| 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
|
|
|
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
|
|
|
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
|
|
|
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. |