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CTRI Number  CTRI/2025/02/079884 [Registered on: 03/02/2025] Trial Registered Prospectively
Last Modified On: 31/01/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Single Arm Study 
Public Title of Study   Improving Nutrition in 3-5 Year-Old Children with Fortified Multigrain and Millet Supplementation in Rural Maharashtra 
Scientific Title of Study   Fortified Multigrain and Millet based Supplementation to Address Malnutrition in 3-5 years old Children in Rural Communities of Maharashtra (Phase-II)  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pratibha Verma 
Designation  Assistant Director 
Affiliation  Mamta Health Institute for Mother and Child 
Address  Department of Maternal and Child Health Division: Research and Programmes Room no.: 330 B-5, Greater Kailash Enclave-II, New Delhi

South
DELHI
110048
India 
Phone  41069597  
Fax    
Email  pratibha@mamtahimc.in  
 
Details of Contact Person
Scientific Query
 
Name  Pratibha Verma 
Designation  Assistant Director 
Affiliation  Mamta Health Institute for Mother and Child 
Address  Department of Maternal and Child Health Division: Research and Programmes Room no.: 330 B-5, Greater Kailash Enclave-II, New Delhi

South
DELHI
110048
India 
Phone  41069597  
Fax    
Email  pratibha@mamtahimc.in  
 
Details of Contact Person
Public Query
 
Name  Neelima Sehgal 
Designation  Deputy Director (Finance) 
Affiliation  Mamta Health Institute for Mother and Child 
Address  Department of Finance and Administration Room no.: 106 B-5, Greater Kailash Enclave-II, New Delhi

South
DELHI
110048
India 
Phone  41069597  
Fax    
Email  neelima.s@mamtahimc.in  
 
Source of Monetary or Material Support  
PepsiCo Foundation under Corporate Social Responsibility Initiative, Intellion Edge, Gurgaon, Southern Peripheral Road, adjacent to Tata Primanti, Dhni, Muhammadur, sector 72, Gurugram, Haryana 122101  
 
Primary Sponsor  
Name  Mamta Health Institute for Mother and Child 
Address  B-5, Greater Kailash Enclave-II, New Delhi 110048  
Type of Sponsor  Other [NGO] 
 
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 
Arvind Bansode  Mamta Health Institute for Mother and Child   Department of Maternal and Child Health, Division: Implementation Room No.:102, House No. 658, Barav, Junnar, 410502
Pune
MAHARASHTRA 
7040362084

arvind@mamtahimc.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Vighnahar Nursing Home, Junnar, Pune, Maharashtra   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E441||Mild protein-calorie malnutrition,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  "Panjiri" prepared from fortified multigrain and millet base food supplement   Fortified Multigrain & Millet based supplement is a mix of grains (Oats, Wheat, Barley) and millet (Ragi) with 18 essential vitamins & minerals which will be used to prepare popular local recipe called - “Panjiri.” The base mix is manufactured by SYMEGHA FOOD INGRDIENTS LTD, Kerala (manufacturing party of PEPSICO INDIA HOLDINGS PRIVATE LIMITED) and have a FSSAI manufacturing license vide license number 10012041000078. Other non-fortified ingredients are peanuts, skimmed milk powder, sugar and ghee and are readily available branded product. Ghee bearing brand name AMUL, skimmed milk powder with brand name SAGAR by AMUL, peanuts with brand name Jabsons Roasted Unsalted peanuts and refined sugar with the brand name PATANJALI will be used. The intervention will be provided to children for 6 months  
Comparator Agent  NIL  Single arm design, comparative group not applicable 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  5.00 Year(s)
Gender  Both 
Details  Child is between 3 to 5 years of age
Children who are mildly wasted i.e. [WHZ greater than -1 SD and less than equal to-2SD and or MUAC greater than-1 SD and less than equal to -2SD
Children whose parents provide consent for participation. In cases where the child is not residing with their parents, consent will be obtained from their legal guardian.
Children should live in the study area for the duration of the intervention.


 
 
ExclusionCriteria 
Details  Children ongoing consumption of other supplementary foods
Any known history of allergy to peanuts or other food ingredients present in the intervention in the child or any direct family member
Children who are found to have moderate and severe acute malnutrition (less than -2 SD from the median weight by height, compared to the reference population)
Any child who has a known history of medical co-morbidity like HIV/ AIDS, TB, or disability or any other chronic childhood diseases.
Any child found to have pedal edema in both the feet.


 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Fortified multigrain and millet based supplementation compliance may improve nutritional status of mildly malnourished children to normal age appropriate growth trajectory and may prevent progression to MAM and SAM
Improved child feeding practices among mothers of children aged 3 to 5 years

 
Evaluation at 3 month and 6 month post intervention for growth parameters
Evaluation at baseline and 6 month post intervention for child feeding practices
 
 
Secondary Outcome  
Outcome  TimePoints 
None  None 
 
Target Sample Size   Total Sample Size="2000"
Sample Size from India="2000" 
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)   11/02/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Adequate nutrition during early childhood is essential to ensure healthy growth, proper organ function, a strong immune system, and neurological and cognitive development. Despite a decade of rapid economic growth, India’s progress in tackling child malnutrition has been slow. In Maharashtra, which has over 112 million people, the prevalence of under-five stunting, underweight, and wasting stands at approximately 35%, 36%, and 26%, respectively, contributing to a high burden of morbidity and mortality among children. In Pune district, the situation is more severe, with wasting rates reaching 31.4%, exceeding both national (19.3%) and state (25.6%) averages. This highest rate of wasting is driven by inadequate dietary intake, poor hygiene, and sanitary practices that lead to recurrent infections.

Mildly malnourished children who are not adequately or timely treated may progress to moderate or even severe forms of acute malnutrition, a condition associated with higher fatality rates. Studies conducted in Guatemala and Mexico has shown that supplementary feeding combined with caregiver counseling, is effective in resolving mild acute malnutrition among preschool children.

Given the high incidence of wasting among children in Pune, this project aims to address mild acute malnutrition among 3-5-year-old children by providing fortified multigrain and millet-based supplementation. This supplementation, delivered in the form of "Panjiri," a traditional food fortified with 18 micronutrients, is designed to prevent progression from mild undernutrition to moderate acute malnutrition. Clinical studies in Mexico have shown that supplementation in the form of cookies, containing nutrients similar to those in Panjiri, can significantly improve weight and height in children with moderate acute malnutrition.

The first phase of the project, implemented across 321 Anganwadi Centers in Maval and Mulshi blocks of Pune district, provided “Panjiri” to 1,000 mildly malnourished children for six months. This intervention resulted in a 55% improvement in nutritional status, bringing children up to normal growth standards. Furthermore, caregivers’ knowledge and behaviors regarding nutrition, health, and hygiene showed a significant improvement, increasing from 21.5% at baseline to 96.9% after targeted education and engagement sessions were conducted with them.

The positive outcomes of phase-1 suggest that expanding the initiative could amplify its impact and provide a robust model for addressing child malnutrition in other blocks of Pune district. Government authorities from Integrated Child Development Scheme (ICDS), Department of Women and Child development and Zilha Parishad, Pune district have also recognized the need to address malnutrition in the hard-to-reach areas of Junnar and Ambegaon blocks. These regions, characterized by challenging terrain, hamper regular access to essential healthcare and nutrition services. Expanding this program would provide a comprehensive approach to improving the nutritional status of mildly malnourished children, ultimately contributing to the long-term well-being and development of these communities.

Objectives

·     To assess the impact of additional nutrition supplementation for 3-5 years’ children of mild acute malnutrition [WHZ between -1 SD and -2SD and or MUAC for age Z score between -1 SD and -2SD], along with focused nutrition education intervention to their parents on the nutritional status of children;

·     To assess changes in the Knowledge of nutrition, health, hygiene and sanitation practices among mothers/caretakers of children with mild acute malnutrition.

Expected Outcomes

·         High compliance with fortified multigrain & millet based supplementation may reduce the prevalence of mild acute malnutrition, improving children’s nutritional status to normal grade.

·         Improved child feeding practices of mothers of children aged 3-5 years.

Two thousand mildly malnourished children will be identified through screening, including standard anthropometric measurements. Identified children will be enrolled in the intervention to receive additional supplementation, in addition to their regular diets, both at home and at Anganwadi Centers (AWCs), along with nutrition education sessions for their caregivers. The effectiveness of the program will be evaluated through repeated anthropometric measurements at 3 and 6 months.


 
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