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CTRI Number  CTRI/2026/01/102427 [Registered on: 29/01/2026] Trial Registered Prospectively
Last Modified On: 28/01/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Cluster Randomized Trial 
Public Title of Study   A study to examine the effect of millets for Anganwadi going children 
Scientific Title of Study   Effectiveness of millet based supplementary nutrition on the nutrition status of preschool children aged 3 years to 6 years attending Anganwadi centres under the Integrated Child Development Project in the rural population in Nagpur District 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ranjan Solanki 
Designation  Additional Professor  
Affiliation  AIIMS Nagpur  
Address  Plot no.2, Sector -20, MIHAN, Nagpur Nagpur MAHARASHTRA 441108 India

Nagpur
MAHARASHTRA
441108
India 
Phone  7264821671  
Fax    
Email  drranjansolanki@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ranjan Solanki 
Designation  Additional Professor  
Affiliation  AIIMS Nagpur  
Address  Plot no.2, Sector -20, MIHAN, Nagpur Nagpur MAHARASHTRA 441108 India


MAHARASHTRA
441108
India 
Phone  7264821671  
Fax    
Email  drranjansolanki@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ranjan Solanki 
Designation  Additional Professor  
Affiliation  AIIMS Nagpur  
Address  Plot no.2, Sector -20, MIHAN, Nagpur Nagpur MAHARASHTRA 441108 India


MAHARASHTRA
441108
India 
Phone  7264821671  
Fax    
Email  drranjansolanki@gmail.com  
 
Source of Monetary or Material Support  
Department of Science and Technology, Technology Bhavan, New Mehrauli Road,, New Delhi 110 016 Telephone 1126590215 
 
Primary Sponsor  
Name  Department of Science and Technology 
Address  Department of Science and Technology, Technology Bhavan, New Mehrauli Road,, New Delhi 110 016 Telephone 1126590215 
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 Ranjan Solanki  All India Institute of Medical Sciences Nagpur  Department of Community Medicine, 4th floor, room no 417, Plot no. 2, Sector-20, Mihan Nagpur, 441108
Nagpur
MAHARASHTRA 		 7264821671

drranjansolanki@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC AIIMS Nagpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  The children attending Anganwadis (3–6yrs) and willing to be a part of the trial will be enrolled as the study participants. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional and routine mid-day meal for children in the control arm  Control arm[C]: 20 randomly selected Anganwadi Centres in the catchment area of PHC Borkhedi will comprise the intervention arm. Four hundred children (200 Girls and 200 boys) of 3yrs to 6yrs of age will form the cluster for the control arm. Routine ongoing mid-day meal will be continued for he control arm with not any intervention. 
Intervention  To study the effectiveness of Millet-based supplementary nutrition on the nutrition status of preschool children aged 3- 6 years attending Anganwadi centres under the Integrated Child Development project in the rural population in Nagpur district, Maharashtra.   Intervention arm [I]: 20 randomly selected Anganwadi Centres in the catchment area of PHC Bela will comprise the intervention arm. Four hundred children (200 Girls and 200 boys) of 3yrs to 6yrs of age will form the cluster for the intervention arm. Pilot testing of the supplements: Merino Innovation Centre under VNIT has developed different millet products. Before the trial, a pilot test of the millet-based supplement food products, including Millet cookies, millet shankarparas, millet sev, millet pancakes, and millet laddoos, will be conducted. 1. In any one Anganewadi, we will introduce millet cookies, millet shankarparas, millet sev, millet chaklis, millet pancakes, and millet laddoos to the attendees at Anganwadi. We will check the participants test preferences for the food item. Based on the result, we will make a roster of millet food items to be distributed six days/ week. 2. The millet-based products preferred by the participants will be delivered more frequently. (twice or thrice a week) • Field investigators will ensure the distribution of food by the participants. They will maintain a register of attendance and intake of the food by the participants. If participants are absent on a particular day, the field investigators will ensure that they consume food at home. Quality control and storage of the millet-based supplements: The packaged dry food will be checked for bacteriological contamination on a monthly basis by the Merino Innovation Centre under VNIT. They will be stored in a dry, airtight, locked container at the Anganwadis every month. They will be delivered by the Merino Innovation Centre under VNIT to Anganwadis every month in airtight containers. 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  6.00 Year(s)
Gender  Both 
Details  The children attending Anganwadis (3–6yrs) and willing to be a part of the trial will be enrolled as the study participants. 
 
ExclusionCriteria 
Details  The children with seriously diagnosed illnesses and who refuse to be a part of the trial will be excluded from the trial. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess the developmental milestones, Hemoglobin, and anthropometric indicators like MUAC, Weight for Age, Height for Age, Weight for Height  at 6 months and at 12 months 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="800"
Sample Size from India="800" 
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)   01/08/2026 
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="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   This study is a community-based pragmatic cluster trial designed to evaluate the effectiveness of millet-based supplementary nutrition on the nutritional status and developmental outcomes of preschool children aged 3 to 6 years attending Anganwadi centres under the Integrated Child Development Services (ICDS) in rural areas of Nagpur district, Maharashtra. A total of 800 children will be enrolled from 40 Anganwadi centres, with 20 centres each allocated to the intervention and control arms. Children in the intervention arm will receive millet-based supplementary food products in addition to routine ICDS nutrition for six months, while the control arm will continue to receive standard ICDS supplementary nutrition alone. Outcomes will be assessed using anthropometric indicators (weight, height, MUAC, weight-for-age, height-for-age, and weight-for-height z-scores) and developmental milestones using a standardized pediatric development screening tool at baseline and post-intervention. The study aims to generate evidence on the role of locally available, nutrient-dense millet-based foods in improving child nutrition and development in rural settings. 
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