| 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
|
|
|
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
|
|
|
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 “Panjiriâ€
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. |