| 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
|
|
|
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
|
|
|
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. |