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CTRI Number  CTRI/2023/12/060519 [Registered on: 19/12/2023] Trial Registered Prospectively
Last Modified On: 28/12/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To evaluate the effectiveness and safety of Milk Basic Protein for height growth in children 
Scientific Title of Study   A 24-week, multi-center, randomized, double-blind, placebo-controlled, three-armed, parallel design study to evaluate the efficacy and safety of Milk Basic Protein for height growth in children. 
Trial Acronym  Not Applicable 
Secondary IDs if Any  
Secondary ID  Identifier 
21PR0093-008 version 2.0 Dated. 17 Oct 2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Abhishek Chavan 
Designation  MD (Paediatrics) 
Affiliation  Noble care Childrens Hospital 
Address  Noble care Childrens Hospital BC No 178 Near Traffic Police station, Havelock Rd Belagavi Karnataka 590001

Belgaum
KARNATAKA
590001
India 
Phone  9900291629  
Fax    
Email  abhishek.chavan34@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jang Yul Kwak 
Designation  Director 
Affiliation  Syncorp Health Pvt Ltd 
Address  Building 06, 3rd Floor, 2nd Main Rd, Opposite To British Biologicals Sarvobhogam Nagar, Arekere Bangalore KARNATAKA India Bangalore KARNATAKA 560076 India

Bangalore
KARNATAKA
560076
India 
Phone  8970888899  
Fax    
Email  deankwak@syncorp.in  
 
Details of Contact Person
Public Query  
Name  Subham Dutta 
Designation  VP,Business Operations 
Affiliation  Syncorp Health Pvt Ltd 
Address  Building 06, 3rd Floor, 2nd Main Rd, Opposite To British Biologicals Sarvobhogam Nagar, Arekere Bangalore KARNATAKA India Bangalore KARNATAKA 560076 India

Bangalore
KARNATAKA
560076
India 
Phone  08049774772  
Fax    
Email  subham.dutta@syncorphealth.com  
 
Source of Monetary or Material Support  
Ju Yeong NS Co. Ltd, 1403 1412 Building A 201 Songpa daero Songpa gu Seoul Munjeong dong Songpa Tera Tower 2 
 
Primary Sponsor  
Name  Ju Yeong NS Co. Ltd. 
Address  1403 1412 Building A 201 Songpa daero Songpa gu Seoul Munjeong dong Songpa Tera Tower 2  
Type of Sponsor  Other [Miscellaneous Food Manufacturing] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jyothi S Doshetty   Belagavi Institute of Medical Sciences, Belagavi  Dr B R Ambedkar Rd, Sadashiv Nagar, Belagavi, Karnataka 590019
Belgaum
KARNATAKA 		 9611714885

drjyothipgbelgaum@gmail.com 
Dr Abhishek Chavan  Noble Care Childrens Hospital  Noble Care Childrens Hospital BC No 178 Near Traffic Police station Havelock Rd Belagavai Karanataka 590001
Belgaum
KARNATAKA 		 9900291629

abhishek.chavan34@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Belagavi Institute of Medical Sciences, Belagavi  Approved 
Ethiclin Private Limited IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Children within the range of 3rd percentile (inclusive of 3rd) and 50th percentile (exclusive of 50th) of height according to the Indian Academy of Pediatrics Growth Chart for the same gender and age. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo (Dextrose anhydrous)  Dose: 0 mg as Milk Basic Protein Dosage form: brown oval chewable tablet Route of administration: Oral Intervention: 24 weeks 
Intervention  Test Product A-Low Dose (Milk Basic Protein 40 mg/day)  Dose: 40 mg as Milk Basic Protein Dosage form: brown oval chewable tablet Route of administration: oral Intervention: 24 weeks 
Intervention  Test Product B-High Dose (Milk Basic Protein 80 mg/day)  Dose: 80 mg as Milk Basic Protein Dosage form: brown oval chewable tablet Route of administration: Oral Intervention: 24 weeks 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  11.00 Year(s)
Gender  Both 
Details  1.Children between the age of 6 and 11 years (both inclusive) at screening.
2.Children within the range of 3rd percentile (inclusive of 3rd) and 50th percentile (exclusive of 50th) of height according to the Indian Academy of Pediatrics Growth Chart for the same gender and age.
3.Children who did not develop secondary sexual characteristics according to investigator’s diagnosis (Tanner Stage1 only).
4.School going children who voluntarily decide to participate after hearing a detailed explanation and fully understanding this study agree to abide the precautions by the written consent of both children their own and legal guardian.
 
 
ExclusionCriteria 
Details  1.Children who are sensitive or allergic to the investigational product.
2.Children who are being treated or have a history of chromosomal abnormalities, genetic abnormalities, skeletal dysplasia, achondroplasia/hypoplasia, etc.
3.Children with growth retardation due to endocrine diseases (growth hormone deficiency, hypothyroidism, type 1 diabetes, pituitary tumor, etc.) and chronic diseases.
4.Children who have been diagnosed with precocious puberty through the investigator’s medical examination, physical examination, and hormone test.
5.Children with bone age (months) differing from the chronological age by more than 18 months.
6.Children with severe anemia (6-11 years: children with hemoglobin less than 8 g/dL).
7.Children with weight less than 5th percentile of weight according to the Indian Academy of Pediatrics Growth Chart for the same gender and age.
8.Children with a history of intrauterine growth retardation (IUGR).
9.Children with birth weight less than 2.5 kg
10.Children who are diagnosed with or have a history of gastrointestinal disorders that may affect the absorption of the test food (e.g., gastrointestinal ulcer, gastritis, gastric spasm, gastroesophageal reflux disease, Chron’s disease) and gastrointestinal surgery (excluded for children with a history of appendectomy or hernia surgery).
11.Children who are being treated or have a corresponding disease with clinically significant liver, pancreas, kidney, nervous system, respiratory system, endocrine system, blood/tumor, mental disease, cardiovascular system, urinary system. Especially, children who have a history of serious heart disease, manic/hypomanic or bipolar disorder, major psychiatric disorders such as depression, anxiety disorder, suicidal tendency, and schizophrenia.
12.Children who took medicines, health functional food, or herb medicine related to height growth within 3 months prior to screening.
13.Children treated with hormone replacement therapy, calcitonin, phosphonate, or growth hormone within 6 months prior to screening.
14.Children who are diagnosed with ADHD or in treatment with drug (e.g., methylphenidate, etc.) within 3 months prior to screening.
15.Children who show any of the following results in clinical pathology tests
- AST or ALT 2.5 times greater than the upper limit of the normal range
- Serum Creatinine 2.5 times greater than the upper limit of the normal range.
16.Glycated hemoglobin (HbA1c) level greater than 6.5%.
17.Uncontrolled hypertension (systolic blood pressure greater than or equal to 130 mmHg, diastolic blood pressure greater than or equal to 80 mmHg) and heart rate greater than or equal to 140 bpm.
18.Children who participated in other clinical trials within 3 months prior to screening.
19.Children, judged by the principal investigator, who are inappropriate to participate in this study due to other reasons including diagnostic test results.
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Height (change in amount)  screening, baseline, week 8, week 16, and week 24 
 
Secondary Outcome  
Outcome  TimePoints 
1 Height change in rate
2 Height Growth Velocity
3 Height for Age z score change in amount and rate
4 Height for Age z score for Bone Age change in amount and rate
5 Growth Indicator
Insulin like Growth Factor 1 change in amount and rate
Insulin like Growth Factor Binding Protein 3 change in amount and rate
IGF 1 IGFBP 3 Ratio change in amount and rate
Growth Hormone change in amount and rate
6 Bone Age by X ray change in amount and rate
 		 1. screening, baseline, week 8, week 16, and week 24
2. week 8, week 16, and week 24
3. baseline, week 8, week 16 and week 24
4. baseline and week 24
5. screening and week 24
6. screening and week 24 
1. Occurrence of Adverse Events
2. Weight and Body Mass Index
3 Vital Signs
Systolic Blood Pressure, Diastolic Blood Pressure, Heart Rate, Body Temperature
4 Complete Blood Tests
WBC, RBC, Hemoglobin, Hematocrit, Platelets, Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil
5 Blood Chemistry
AST, ALT, γ-GTP, ALP, Total Bilirubin, Total Cholesterol, Triglyceride, HDL-C, LDL-C, Serum Creatinine, Glucose, HbA1c, BUN, Uric Acid, Albumin
6 Urinalysis
pH, Protein, Glucose, WBC, RBC, Nitrite, Specific Gravity, Ketone, Urobilinogen, Bilirubin
7 Hormone Test
Estradiol (girls only), Testosterone (boys only), Luteinizing Hormone, Follicle-Stimulating Hormone, Thyroid-Stimulating Hormone 		 1. Screening, Baseline, week 8, week 16, and week 24
2. screening, baseline and week 24
3. screening, baseline, week 8, week 16, and week 24
4. screening and week 24
5. screening and week 24
6. screening and week 24
7. screening and week 24 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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 3 
Date of First Enrollment (India)   29/12/2023 
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="11"
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   The aim of this clinical trial is to objectively demonstrate that Milk Basic Protein intake can support height growth in children, and based on the previous studies conducted Milk Basic Protein is expected to have a greater benefit than the risks including the side effects. The administration of nutritional interventions to undernourished children can promote catch-up growth more effectively in the very young. Therefore, efforts to prevent further growth faltering and promote catch-up growth should be given to children who have missed the growth.  Milk Basic Protein is a functional ingredient recognized to be may help to maintain healthy bone with in vitro studies showing increased osteoblast and chondrocyte proliferation, and animal studies showing increased bone mineral density and growth plate length. It is speculated that Milk Basic Protein can also help stimulate height growth in children. Individuals with a history of milk and dairy allergies should use caution when consuming the product. No prior clinical study has been conducted on the effect of Milk Basic Protein on children’s height growth. 
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