None listed
Conditions
Interventions
Intervention1: 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
Sponsors
Ju Yeong NS Co. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Height (change in amount)Timepoint: screening, baseline, week 8, week 16, and week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 Timepoint: 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, ?-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 HormoneTimepoint: 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 | — |
Countries
India
Contacts
Public ContactSubham Dutta
Syncorp Health Pvt Ltd
Outcome results
None listed