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CTRI Number  CTRI/2023/04/051566 [Registered on: 12/04/2023] Trial Registered Prospectively
Last Modified On: 07/05/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Single Arm Study 
Public Title of Study   Effect of an oral nutrition supplement on growth in Indian children in age group 3-6.9 years at nutritional risk 
Scientific Title of Study   Effect of an oral nutrition supplement on growth in Indian children in age group 3-6.9 years at nutritional risk: A prospective, randomized, open label, controlled, parallel study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ms Neelambari Bhosale 
Designation  Head Clinical Operations 
Affiliation  JCDC-CRO (Jehangir Clinical Development Centre) 
Address  Jehangir Clinical Development Centre Pvt Ltd Jehangir Hospital Premises, 32 Sassoon Road, Pune 411001, Maharashtra, India.

Pune
MAHARASHTRA
411001
India 
Phone    
Fax    
Email  neelambari@jcdc.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Anuradha Khadilkar 
Designation  Consultant Paediatrics 
Affiliation  Jehangir Clinical Development Centre Pvt Ltd 
Address  Jehangir Clinical Development Centre Pvt Ltd Jehangir Hospital Premises, 32 Sassoon Road, Pune 411001, Maharashtra, India.

Pune
MAHARASHTRA
411001
India 
Phone  9850244305  
Fax    
Email  anuradhavkhadilkar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Aquil Faruqui 
Designation  Head Strategic Partnerships 
Affiliation  JCDC-CRO(Jehangir Clinical Development Centre) www.jcdc.co.in 
Address  Jehangir Clinical Development Centre Pvt Ltd Jehangir Hospital Premises, 32 Sassoon Road, Pune 411001, Maharashtra, India.

Pune
MAHARASHTRA
411001
India 
Phone  9820033370  
Fax    
Email  aquil.faruqui@jcdc.co.in  
 
Source of Monetary or Material Support  
Abbott Healthcare Pvt Ltd, Floor 15, Godrej BKC, Bandra (E), Mumbai 400051. 
 
Primary Sponsor  
Name  Abbott Healthcare Pvt Ltd 
Address  Floor 15, Godrej BKC, Bandra (E), Mumbai 400051 
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 Anuradha Khadilkar  Jehangir Clinical Development Centre Pvt Ltd  Jehangir Hospital Premises, 32 Sassoon Road, Pune- 411001, Maharashtra, India. Pune MAHARASHTRA
Pune
MAHARASHTRA 		 9850244305

anuradhavkhadilkar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee Jehangir Clinical Development Centre Pvt Ltd  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E639||Nutritional deficiency, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Dietary counseling  •Dietary counseling will be provided for subjects in both the arms as per their age, physical status, and daily physical activities. •The dietary advice, given by the study center nutritionist to the parents or LAR of the subjects.  
Intervention  Oral nutritional supplement (Pediasure) and Dietary counselling  Dosage Form: To prepare a 45.5 g serving, 1 product sachet should be completely added to 190 mL of water to make a 225ml of drink. Dosage Frequency: All subjects in the interventional arm will be administered the study product twice daily (45.5 g per serve) in addition to his/her regular diet, for which the subjects’ parent or LAR will receive dietary advice. The mixture will be thoroughly stirred until the study product completely dissolves and should be consumed immediately by the subject. Subjects in the control arm will not receive any product. The subject’s parent or LAR will be given dietary 23 advice and will be instructed to follow a regular diet for the subject throughout the study duration  
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  6.90 Year(s)
Gender  Both 
Details  A subject will be considered eligible for inclusion in this study only if ALL of the following criteria apply:
1. Subject (male or female) aged 3.0-6.9 years, and residing in India
2. Subject to remain in the same locality for the duration of the study (up to 6 months)
3. Subject has a Height for age less than 25th percentile according to current WHO Growth Charts (WHO Growth Chart 2007)
4. Subject has a weight for height less than 25th percentile according to current WHO Growth Charts (WHO Growth Chart 2007)
5. Subject is able to consume foods and beverages orally
6. Child is a picky eater, defined as meeting at least two of the following criteria. A child, who a. eats only a limited number of foods b.is unwilling to try new foods c. refuses to eat vegetables and or foods from other food groups d. shows strong food likes and dislikes 16 e. has behaviors that disrupt mealtime
7. Child is a habitual milk drinker at least 1 glass (approx. 200ml) of milk daily.
8. Subject with good general and mental health in the investigator’s opinion 9. Subject’s parent or LAR understand and are willing, able and likely to comply with all study procedures and restrictions
10. Subject’s parent or LAR are willing to accommodate frequent home visits or telephonic communication by the study personnel.
11. Subject’s parent or LAR are willing to sign the ICF.
 
 
ExclusionCriteria 
Details  Subject’s meeting any of the following criteria are not eligible for the study:
1. Subject has been diagnosed with Lactose Intolerance & Galactosemia according to medical records or parent or LAR report.
2. Subject has been diagnosed or is known to be allergic or intolerant to any ingredient found in the study product according to medical records or parent or LAR report.
3. Subject has been diagnosed with a developmental disability, including pathological reason for stunted & wasting, physical disorders such as cerebral palsy, or developmental delay according to medical records or parent or LAR report.
4. Subject with recent history (within 3 months prior to signing ICF) of surgery, serious infections or injuries
5. Subject who is immunocompromised (e.g. HIV infection, AIDS, congenital immunodeficiency) or has known congenital diseases or malformations (e.g. gastrointestinal malformations) or has a history of endocrine abnormality or has chronic illnesses or conditions (e.g. jaundice, asthma, diabetes, cancer, tuberculosis, diarrhea, etc) or medications (e.g. systemic corticosteroids) which could interfere with the study objectives
6. Subject who needs to be fed with a special diet OR who needs to be fed with a diet which is different from that advised by the study center nutritionist OR current taking a nutritional supplement (MVM with average consumption of greater than or equal to 10 percent) in the past 3 months prior to screening
7. Subject on restrictions that prevent adherence to the diet plan, which is advised by the study center nutritionist during dietary advice 17
8. Subject with known food allergies as reported by parent or LAR
9. Subject currently participating, or has participated in a drug or device study or a nutritional program run by the local government or NGO within a period of 30 days prior to screening 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Change in height-for-age WHO percentile  at 6 months compared to baseline 
 
Secondary Outcome  
Outcome  TimePoints 
1. Change in height-for-age WHO percentile
2. Change in height-for-age WHO z-score
3. Change in weight-for-height WHO percentile
4. Change in weight-for-height WHO percentile
5. Change in weight-for-height WHO z-score
6. Change in WHO BMI for age z-score and percentile
7. Change in weight for age WHO z- score and percentile
8. Change in mid upper arm circumference-for-age WHO z-score and percentile
9. Number of sick days
10. Number of sick episodes
11. Change in calorie intake
 		 at 3 months compared to baseline.
at 3 and 6 months compared to baseline.
at 3 months compared to baseline.
at 6 months compared to baseline.
at 3 and 6 months compared to baseline.
at 3 and 6 months compared to baseline
at 3 and 6 months compared to baseline
at 3 and 6 months compared to baseline

at 3 and 6 months
at 3 and 6 months
at 3 and 6 months compared to baseline
 
 
Target Sample Size   Total Sample Size="234"
Sample Size from India="234" 
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)   23/06/2023 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  		 The study is being conducted to evaluate the effect of an oral nutrition supplement on growth in Indian children in age group 3-6.9 years at nutritional risk. The study will investigate the effect of oral nutritional supplement (ONS) along with dietary counselling vs only dietary counselling on anthropometric growth parameters among preschool children from India, aged ≥ 3 to 6.9 years. 
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