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CTRI Number  CTRI/2025/08/092312 [Registered on: 04/08/2025] Trial Registered Prospectively
Last Modified On: 09/04/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Other 
Public Title of Study   A Study on the Acceptability of micronutrient Nutritional Sprinkler Formulation in Children of age 4-12 diagnosed with Cancer. 
Scientific Title of Study   To assess the acceptance of the micronutrient sprinkler formulations in pediatric patients with cancer. 
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 MAYA PRASAD 
Designation  Professor, Medical oncology F, (Pediatrics))  
Affiliation  Tata Memorial Hospital  
Address  Pediatric Medical Oncology, OPD 80, Ground floor, Main Building, Tata Memorial Hospital, Dr. Ernest Borges Road, Parel, Mumbai - 400012
Tata Memorial Hospital, Dr. Ernest Borges Road, Parel, Mumbai - 400012
Mumbai (Suburban)
MAHARASHTRA
400012
India 
Phone  9819379113  
Fax    
Email  maya.prasad@gmail.com   
 
Details of Contact Person
Scientific Query
 
Name  Dr MAYA PRASAD 
Designation  Professor, Medical oncology F, (Pediatrics))  
Affiliation  Tata Memorial Hospital  
Address  Pediatric Medical Oncology, OPD 80, Ground floor, Main Building, Tata Memorial Hospital, Dr. Ernest Borges Road, Parel, Mumbai - 400012
Tata Memorial Hospital, Dr. Ernest Borges Road, Parel, Mumbai - 400012
Mumbai (Suburban)
MAHARASHTRA
400012
India 
Phone  9819379113  
Fax    
Email  maya.prasad@gmail.com   
 
Details of Contact Person
Public Query
 
Name  Dr MAYA PRASAD 
Designation  Professor, Medical oncology F, (Pediatrics))  
Affiliation  Tata Memorial Hospital  
Address  Pediatric Medical Oncology, OPD 80, Ground floor, Main Building, Tata Memorial Hospital, Dr. Ernest Borges Road, Parel, Mumbai - 400012
Tata Memorial Hospital, Dr. Ernest Borges Road, Parel, Mumbai - 400012
Mumbai (Suburban)
MAHARASHTRA
400012
India 
Phone  9819379113  
Fax    
Email  maya.prasad@gmail.com   
 
Source of Monetary or Material Support  
Tata Memorial Hospital, Dr. E. Borges Road, Parel, Mumbai-400012 
 
Primary Sponsor  
Name  IIT Bombay 
Address  Powai, Mumbai, Maharashtra 400076 
Type of Sponsor  Research institution 
 
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 MAYA PRASAD  Tata Memorial Hospital  Department of Pediatric Oncology, OPD 80, Ground floor, Main Building, Dr E Borges Road, Parel, Mumbai-400012
Mumbai (Suburban)
MAHARASHTRA 
09819379113

maya.prasad@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee-ll, IRB  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C00-D49||Neoplasms, (2) ICD-10 Condition: E638||Other specified nutritional deficiencies, (3) ICD-10 Condition: E617||Deficiency of multiple nutrient elements,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  micronutrient Sprinkler Formulation  The intervention is a food-based micronutrient sprinkler formulation developed by IIT Bombay, designed for pediatric cancer patients. It is a dry powder supplement containing essential vitamins, minerals, amino acids, and probiotics, available in four flavours: Maggie masala, chocolate, chat masala, and unflavoured. Each child will receive 40 grams per day (10g × 4 times) for 10 days. From Day 0–3, all four flavours are given; from Day 4–10, the two most preferred flavours (based on a Likert scale) are continued. The study assesses acceptability, palatability, compliance, and changes in nutritional status. 
Comparator Agent  NIL  Not Applicable 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1 Children aged between 4 to 12 years and diagnosed with solid tumors
2 Patients receiving active treatment (chemotherapy -radiation)
3 Receiving treatment at Tata Memorial Hospital Parel 
 
ExclusionCriteria 
Details  1 Presence of grade-3 or more adverse events, specifically nausea, vomiting and diarrhea
2 Refusal of informed consent
3 Patients on nasogastric tube feeds
4 Patients with any food allergies 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Acceptance of the sprinkler formulation(s), assessed through a Likert scale
 
Likert scale assessment will be conducted on Day 3 to identify the two most preferred flavours to be given until day 10.
 
 
Secondary Outcome  
Outcome  TimePoints 
1. Palatability: Taste, texture, and overall acceptability of the supplement to pediatric patients.
2. Compliance: Assess how well patients adhere to the prescribed regimen of the supplements
 
Nutritional assessments on Day 3 and Day 11 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 1/ Phase 2 
Date of First Enrollment (India)   20/08/2025 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
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  

This study aims to see if improving nutrition can help undernourished children with cancer do better during treatment. Specifically, it will test if giving them a special food supplement with the right amounts of protein, calories, vitamins, and minerals can help them handle chemotherapy, reduce health issues, and improve their chances of survival. The study will focus on children in need, particularly in less developed countries. For 10 days, 30 children will take part in the study. The children will be given a daily 40-gram food supplement, divided into four small servings throughout the day. The supplement comes in four flavors: Maggie masala, chocolate, chat masala, and unflavored. In the first 3 days, all flavors will be given to the children. After that, parents will help their child pick their two favorite flavors to continue with. A dietitian will closely monitor the children’s health, and parents will fill out a simple questionnaire about how the child likes the food, as well as keep a diary of any reactions or changes they notice. Nutritional assessments will be done on the first and last day of the study to check for improvements, and blood samples will also be taken to study how the supplement affects the children’s bodies. Throughout the study, the parents will be kept informed and supported by the study team. The goal is to gather valuable information on how nutrition can improve cancer treatment outcomes for these children and acceptability of the formulation by children.

 
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