| CTRI Number |
CTRI/2024/12/078254 [Registered on: 17/12/2024] Trial Registered Prospectively |
| Last Modified On: |
26/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To test the effect of Kids Nutri Immuno Supplement in improving growth, performance and immunity in children. |
|
Scientific Title of Study
|
An open label clinical study to evaluate the efficacy and safety of Kids Nutri Immuno Supplement in improving the growth, cognition, performance, immunity and reducing the incidence of upper respiratory tract and gastrointestinal infections in children. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Protocol No: KIDSNUTRI/20/24 Version: 1.2, Date: 11-11-2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ananda Babu MBBS |
| Designation |
Consultant |
| Affiliation |
Sree Lakshmi Hospital |
| Address |
Room No 1 General Medicine Dept No 41 Karunanidhi Street Nehru Nagar Velachery
Room No 1 General Medicine Dept No 41 Karunanidhi Street Nehru Nagar Velachery
Chennai
TAMIL NADU
600042
India |
| Phone |
9566086072 |
| Fax |
|
| Email |
dranandbabu4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramesh Kannan |
| Designation |
Assistant professor |
| Affiliation |
Ki3 Private Limited |
| Address |
Room no:5, Department of Pharmacology,Vellore Medical College, Tamil Nadu
Vellore
TAMIL NADU
632004
India |
| Phone |
7708925866 |
| Fax |
|
| Email |
srkguruvarshan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gayathri Sivakumar |
| Designation |
Director |
| Affiliation |
Ki3 Private Limited |
| Address |
Room No 1, Ki3 Office, Regus Centre Level 2, Altius Block No 1, SIDCO Industrial Estate, Chennai
Room No 1, Ki3 Office, Regus Centre Level 2, Altius Block No 1, SIDCO Industrial Estate, Chennai
Chennai
TAMIL NADU
600032
India |
| Phone |
9003109416 |
| Fax |
|
| Email |
drgayathri@ki3services.com |
|
|
Source of Monetary or Material Support
|
| Naturo Health Matters Pvt. Ltd. |
|
|
Primary Sponsor
|
| Name |
Naturo Health Matters Pvt. Ltd. |
| Address |
12 A M C GARDEN ROAD 1ST FLOOR,
SETHBAGAN, KOLKATA, WEST BENGAL, 700030,
Kolkata, West Bengal-700030 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ramesh Kannan |
Grace in Trinity Hospital |
Consultation room, 54B, Avalurpet Road,
Chetpet
Chennai
TAMIL NADU |
9677786447
srkguruvarshan@gmail.com |
| Dr Ramesh Kannan |
PM Medical Centre |
Room no:10, Medicine OPD,PMMedical Centre, Wallajapet,Ranipet, Vellore
Vellore
TAMIL NADU |
9677786447
srkguruvarshan@gmail.com |
| Dr Ananda Babu MBBS |
Shree Lakshmi Hospital |
Room No 1 General Medicine Dept No 41 Karunanidhi Street Nehru Nagar Velachery
Chennai
TAMIL NADU |
9566086072
dranandbabu4@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Oxymed Ethics Committee |
Approved |
| PM ethics committee |
Approved |
| PM ethics committee |
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 |
Kids Nutri Immuno Supplement |
24 eligible participants will receive Kids Nutri Immuno Supplement daily orally for 8 weeks + standard of care treatment if required |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children with malnutrition will be enrolled in the study.
Performing a nutritional assessment that compares a childs measurements to standard values.
Height for age - Compared to the median of the WHO child growth standards, if the childs height is less than 2 standard deviations (SD) below, this is considered stunting.
Weight for height- If the childs weight is less than 2 SD below the median of the WHO child growth standards, this is considered wasting and by measuring Mid Upper Arm Circumference (MUAC).
Providing consent by understanding the study and willingness to participate as evidenced by subjects parents and or legal guardians voluntary written informed consent.
|
|
| ExclusionCriteria |
| Details |
Subject with a known allergy or intolerance to the study product or ingredients, on a special diet and cannot consume the study product.
Subject with a current illness requiring hospitalization, subject with GI infection and or acute diarrhea at the time of inclusion in the study.
Subject on medication that could affect absorption/metabolism of the study product.
If the subject is diagnosed with recurrent respiratory infections due to cystic fibrosis, active tuberculosis, acute hepatitis B or C or HIV, malignancy (as per history in the medical records)
Subject with a history of diabetes (as per history and documentation in the medical records)
Subject been on antibiotic therapy within the last 1 month before the start of the study (before study day 1)
Subject with dysphasia, aspiration risk, and difficulty in swallowing due to acquired or congenital abnormalities that would hamper oral intake of the study product (as per history and documentation in the medical records)
Subject with a clinically significant nutritional deficiency requiring specific treatment with any other nutritional supplement (not study product) as diagnosed by the investigator will also be excluded for the safety concern.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Anthropometric measurements (Height, Weight, BMI, Mid Arm Circumference) and assessment of WHO z score for the same.
Assessment of Emotional and Cognitive Intelligence Questionnaire based on the response from the subjects parent or guardian for cognition, social skills, motivation, self regulation, self awareness, and empathy. Academic performance will also be assessed between pre and post treatment.
Assessment of Child Eating Behaviour Questionnaire eating behaviour like food responsiveness, enjoyment of food, eating speed based on the response from the subjects parent or guardian
Montreal Cognitive Assessment will be assessed between pre and post treatment.
Incidence of URTI or GI health events during the study period
If infected during the study, with URTI or GI infections, the time taken for recovery will be monitored.
Number of school day losses
|
Day 0, Week 4 and week 8 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To monitor for any adverse events including lab abnormalities (CBC, RBS, RFT, LFT and Electrolytes) during the study period (baseline and post study lab parameters) |
Baseline and week 8 |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "24"
Final Enrollment numbers achieved (India)="24" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
31/12/2024 |
| Date of Study Completion (India) |
23/05/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
23/05/2025 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
24
children with malnutrition and history of recurrent upper respiratory tract and
gastrointestinal infections, will be enrolled in the study, For children aged 4–6 years, the
dosage is 15g once daily for 8 weeks. For children aged 7–12 years, the dosage
is 30g, which can be administered once or twice (two divided dosage) daily
depending on the requirement for 8 weeks. Growth, cognition, performance, immunity and the incidence
of upper respiratory tract and gastrointestinal infections will be assessed at each visits |