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CTRI Number  CTRI/2025/12/099617 [Registered on: 22/12/2025] Trial Registered Prospectively
Last Modified On: 22/12/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   “A Study Comparing Weekly (60 mg) and Twice-Weekly (30 mg) Iron Tablets in Healthy Adolescent Girls to Improve Regular Intake and Reduce Side Effects” 
Scientific Title of Study   Impact of Dose Optimization on Compliance to Iron Folic Acid Supplementation among Adolescent Girls: Open labelled Non-Randomized Controlled Trial at Ahmedabad District, Gujarat 
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 Venu Shah 
Designation  Professor, Community Medicine Department 
Affiliation  GCS Medical College, Ahmedabad 
Address  Third Floor, Community Medicine Department, GCS Medical College, Opposite DRM Office, Naroda Road, Ahmedabad

Ahmadabad
GUJARAT
380016
India 
Phone  07966048351  
Fax    
Email  drvenushah@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Venu Shah 
Designation  Professor, Community Medicine Department 
Affiliation  GCS Medical College, Ahmedabad 
Address  Third Floor, Community Medicine Department, GCS Medical College, Opposite DRM Office, Naroda Road, Ahmedabad

Ahmadabad
GUJARAT
380016
India 
Phone  07966048351  
Fax    
Email  drvenushah@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Venu Shah 
Designation  Professor, Community Medicine Department 
Affiliation  GCS Medical College, Ahmedabad 
Address  Community Medicine Department, Third Floor, GCS Medical College, Opposite DRM Office, Naroda Road, Ahmedabad

Ahmadabad
GUJARAT
380016
India 
Phone  07966048351  
Fax    
Email  drvenushah@gmail.com  
 
Source of Monetary or Material Support  
State Health System Resource centre, Old SIHFW Building, Campus of GMERS Sola Medical college, Ahmedabad, Gujarat, 380060 
 
Primary Sponsor  
Name  State Health System Resource Center, Gujarat 
Address  KMD, PHD & Admin Division, GMERS Sola Hospital Campus, Sola, Ahmedabad, 380060 
Type of Sponsor  Government funding agency 
 
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 Venu Shah  GCS Medical College, Ahmedabad  Third Floor, Community Medicine Department, GCS Medical College, Opposite DRM Office, Naroda Road, Ahmedabad, Gujarat, 380016
Ahmadabad
GUJARAT 		 9925044022

drvenushah@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
GCS Medical College, Hospital and Research Centre, Ahmedabad  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Not Applicable 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Biweekly Iron Folic Acid with 30 mg iron   IFA tablets having 30 mg iron and 250 mcg folic acid will be administered twice weekly  
Comparator Agent  Weekly Iron Folic Acid with 60 mg iron  IFA tablets with 60 mg iron and 500 mcg folic acid is administered weekly once as per the routine guideline under national program 
 
Inclusion Criteria  
Age From  14.00 Year(s)
Age To  19.00 Year(s)
Gender  Female 
Details  Adolescent girls in their middle or late adolescent age (14 to 19 years), who herself or whose parents are ready to give written informed assent /consent to participate in the study. 
 
ExclusionCriteria 
Details  1.Adolescent girl who will be anemic at the time of baseline assessment.
2.Adolescent girl who is already on Iron therapy for treatment of anemia.
3.Adolescent girl who is diagnosed with hemoglobinopathies (Sickle cell anemia, Thalassemia major/minor).
4. Adolescent girl who is currently having any kind of systemic illness (Tuberculosis, Diabetes, Hypertension, Thyroid disorders etc.) which requires treatment.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Compliance to Iron and Folic Acid (IFA) supplementation, measured as Proportion of prescribed IFA tablets consumed over the study period, assessed by pill count and/or self-reported intake, compared between weekly 60 mg and twice-weekly 30 mg regimens.  End of intervention period, 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Frequency and type of self-reported side effects  During intervention period 
Hemoglobin level  Baseline and end of intervention  
 
Target Sample Size   Total Sample Size="400"
Sample Size from India="400" 
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)   02/02/2026 
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="0"
Months="6"
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  

Iron-deficiency anemia remains a major public health concern among adolescent girls in India. As per NFHS-5, nearly 59.1% and 69% of adolescent girls aged 15–19 years in India & Gujarat respectively are anaemic. The Weekly Iron and Folic Acid Supplementation (WIFS) program under the National Iron Plus Initiative (NIPI) provides 60 mg elemental iron and 500 mcg folic acid once a week. Despite program implementation, compliance is poor, primarily due to gastrointestinal side effects. Total 400 adolescent girls will be included in the study, out of them 200 will be in study group who will receive biweekly IFA supplementation whereas 200 adolescent girls will be the control group who will receive standard weekly IFA supplementation under National Iron plus initiative. Hemoglobin estimation will be done in the beginning of the study and at the end of 6 months among both groups. Compliance will be ascertained by standard questionnaire and tablets consumption. The compliance rate will be calculated. Compliance will be expressed in percentages. Compliance registers will be filled up by school teachers every weekly. For qualitative insights, FGD (Focused group discussion) sessions in each respective school will be organized regarding compliance of the IFA.

Findings of this open-label non-randomized controlled trial in Ahmedabad district, Gujarat aims to develop specific evidence on whether dose optimization biweekly lower IFA dosage regimen (30 mg iron + 250 mcg folic acid) has any effect on compliance and haemoglobin levels among school going adolescent girls.

 
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