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CTRI Number  CTRI/2024/12/078745 [Registered on: 30/12/2024] Trial Registered Prospectively
Last Modified On: 04/12/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   A Clinical Trial to Evaluate the Effects of Nutritional Supplements in Children Aged 2 to 6 Years with Mild to Moderate Acute Malnutrition in the Sub-Urban Regions of India 
Scientific Title of Study   Effect Of Indigenously Prepared Nutritional Supplement In Children With Mild To Moderate Acute Malnutrition In India Sub-Urban Region - A Prospective Facility-Based Study 
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 Sakshi Dabir 
Designation  Principal Investigator 
Affiliation  Niramay (NGO) 
Address  Niramay (NGO), C/123, Chandranil Housing Society, Near Ramkrishna Math, Sinhagad Road, Pune

Pune
MAHARASHTRA
411030
India 
Phone    
Fax    
Email  niramay.pune@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Pranit Ambulkar 
Designation  Assistant General Manager R & D  
Affiliation  Netsurf Communication Pvt Ltd. 
Address  Netsurf Communication Pvt Ltd., Sr. No. 107, Plot No 2, Laxman Nagar, Baner, Pune

Pune
MAHARASHTRA
411045
India 
Phone  9785587317  
Fax    
Email  pranit.a@netsurfdirect.com  
 
Details of Contact Person
Public Query
 
Name  Dr Mangesh Shende 
Designation  Chief Executive Officer 
Affiliation  Akshar Global Clinical Research Private Limited 
Address  AKSHAR GLOBAL CLINICAL RESEARCH PVT. LTD.,322, Shreeya Amalga, Avalon Hotel Cross Road, Thaltej, Ahmedabad

Ahmadabad
GUJARAT
380054
India 
Phone  9978078056  
Fax    
Email  mangesh.shende@agcro.com  
 
Source of Monetary or Material Support  
Netsurf Communication Pvt Ltd. 
 
Primary Sponsor  
Name  Netsurf Communication Pvt Ltd. 
Address  Netsurf Communication Pvt Ltd., Sr. No. 107, Plot No 2, Laxman Nagar, Baner, Pune – 411045  
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 Sakshi Dabir  Niramay (NGO)  Niramay (NGO)C/123, Chandranil Housing Society, Near Ramkrishna Math, Sinhagad Road, Pune 411030.
Pune
MAHARASHTRA 
7249887861

niramay.pune@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Central Independent Ethics Committee-CIEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E440||Moderate protein-calorie malnutrition,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  15 gram Nutritional supplement with 150 ml of milk for 90 days  15 gram Nutritional supplement with 150 ml of milk in the morning for 90 days 
Comparator Agent  150 ml of milk for 90 days   150 ml of milk in the morning for 90 days  
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  6.00 Year(s)
Gender  Both 
Details  The subjects should follow following inclusion criteria to participate in the study-
1. Children in between 2 -6 years of either sex.
2. Guardian/ parent is willing to provide consent and follow the schedule of the study.
3. Patient evaluated with Grade acute mild to moderate stage of Malnutrition
4. Patients with PEM
 
 
ExclusionCriteria 
Details  The subjects should not present any of the following exclusion criteria-
1. Children who have Systemic diseases like Tuberculosis, Diabetes,
any other grave infectious illness requiring active management.
2. PEM due to Gross congenital problems, Malignancies, Mal-absorption syndrome or inborn errors of metabolism will be excluded.
3. Children evaluated with other grades of PEM, i.e. normal, grade 3.
4. and severe acute malnutrition
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The primary objectives of the study will be to evaluate-
• Growth- Change in weight and height (WHO z-score)
• Improvement-Change in mid arm circumference  
Screening Visit (up to -7 days) to Visit 3 (Day 90 ± 5 days)
 
 
Secondary Outcome  
Outcome  TimePoints 
The secondary objectives of the study will be to evaluate-
• No. of days required to recover from episode of infection
• Eating Behavior Questionnaire (CEBQ)
• Emotional Quotient Questionnaire (EQQ)
• Assessment of Overall Improvement by parent & investigator
 
Screening Visit (up to -7 days) to Visit 3 (Day 90 ± 5 days) 
 
Target Sample Size   Total Sample Size="1000"
Sample Size from India="1000" 
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)   01/01/2025 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

Screening of kids of age between 2 to 6 visiting around 300 Anganwadi in sub-urban area in north Pune will be screened for acute malnutrition with help of NGO ‘Niramay’ and Anganwadi workers. Those falling under acute mild and moderate malnutrition, based on the consent given by the parents will be enrolled for trial group. Those not willing to consume trial supplement, but willing to enroll for health evaluation and guidance regarding home based dietary modification will be enrolled for control group for comparison.

 

On screening visit, a written informed consent will be obtained from subject’s guardian/parents for their participation in the study. Subject’s demographic details will be taken. Subject will undergo clinical examination (general and systemic examination). Subject’s medical, surgical and treatment history will be taken. Subject’s current medication if any will be noted in the case record from (CRF).

 

The subject will be considered for further evaluation as per the inclusion and exclusion criteria.

 

Subject will be called for below visit schedule:

 

·       Screening Visit (up to -7 days)

·       Baseline Visit (Day 1)

·       Visit 1 (Day 30 ± 5 days)

·       Visit 2 (Day 60 ± 5 days)

·       Visit 3 (Day 90 ± 5 days)

 

 

Subject will undergo clinical examination (general and systemic examination). Subject’s anthropometric parameters along with Growth- Change in weight and height (WHO z-score) and Improvement-Change in mid arm circumference at screening and 90 days will be assessed.

 

No. of days required to recover from episode of infection will be recorded. Subject’s change in appetite score, Child Eating Behaviour Questionnaire, emotional Quotient Questionnaire will be assessed. Global assessment of overall improvement will be done by subject’s parent and investigator on last follow up visit. Palatability with dosage compliance will be assessed by the investigator and by subject of test product from baseline to end of the study. All the subjects will be closely monitored for any adverse event/Serious Adverse Event starting from baseline visit till the end of the study visit. After completion of 90 days of study treatment, all the subjects will be asked to stop trial product/medications and take advice of investigator for further treatment.

 
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