Oral Nutritional Supplementation in Picky Eating Children

Study Overview
=================
Brief Summary
-----------------
This study will investigate the effect of two oral nutritional supplements (ONS) along with dietary counseling vs dietary counseling alone on growth among picky eating children from India, aged > 24 months to ≤ 48 months over a period of 90 days.

Detailed Description
-----------------
Study Objective: To investigate the effect of two oral nutritional supplements (ONS) along with dietary counseling vs dietary counseling alone on growth among picky eating children from India, aged > 24 months to ≤ 48 months over a period of 90 days. Number of Subjects / Length of Participation: Approximately 321 subjects (107 subjects per group) will be enrolled from estimated 8-10 study centers to obtain at least 255 evaluable subjects (85 subjects per group), assuming 20% attrition rate. Expected total duration for the study is approximately 12 months. Study Design : Prospective, randomized, double blinded study, with two parallel treatment groups and an open-labeled control group multicenter clinical study Eligible subjects will be randomized into three groups Experimental Group 1: Oral nutritional supplement and dietary counseling. (List No S691/Z0) Experimental Group 2: Oral nutritional supplement and dietary counseling. (List No- P968/Z0) Control Group: Dietary counseling.

Official Title
-----------------
Oral Nutritional Supplementation in Picky Eating Children

Conditions
-----------------
Children - Malnutrition

Intervention / Treatment
-----------------
* Dietary Supplement: Oral nutritional supplement (List No S691/Z0)
* Dietary Supplement: Oral nutritional supplement
* Other: Dietary Counselling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Child is > 24 months and ≤ 48 months of age at visit 1. Child of either gender (Male and Female). Child has a weight-for-height between 3rd - 15th percentiles according to current WHO Growth Charts at visit 1. (WHO Growth Chart 2007) Child is a picky eater, defined as meeting at least two of the following criteria. A child, who: eats only a limited number of foods is unwilling to try new foods refuses to eat vegetables and/or foods from other food groups shows strong food likes and dislikes has behaviors that disrupt mealtime Child is a habitual milk drinker at least 1 glass (approximately 200mL) of milk daily. Child is able to consume foods and beverages orally. Child's Legal Guardian (LG) or parent(s) is willing to abstain from giving additional non-study nutritional supplements including vitamin/mineral supplements, micronutrient fortified beverages, oral nutritional supplements other than the study product during the study intervention period. Child's Legal Guardian (LG) or parent(s) has voluntarily signed and dated an informed consent form (ICF), approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) prior to any participation in the study. Child's Legal Guardian (LG) or parent(s) is able and willing to follow study procedures and record data in parent diary and complete any forms or assessments needed throughout the study. Child's Legal Guardian (LG) or parent(s)is not planning to relocate during the study period Exclusion Criteria: Child has been diagnosed with Lactose Intolerance & Galactosemia according to medical records or Legal Guardian (LG) /parent report. Child has been diagnosed or is known to be allergic or intolerant to any ingredient found in the study product according to medical records or Legal Guardian (LG)/parent report. Child has a current acute or chronic infection including respiratory infection, diarrhea, acute or chronic, Hepatitis B or C, HIV infection or tuberculosis according to medical records or Legal Guardian (LG)/parent report. Child has been diagnosed with presence of severe gastrointestinal disorders including celiac disease, short bowel syndrome, pancreatic insufficiency, or cystic fibrosis according to medical records or Legal Guardian (LG)/parent report. Child has been diagnosed with neoplastic, renal, hepatic or cardiovascular disease according to medical records or Legal Guardian (LG) /parent report. Child has been diagnosed with hormonal or metabolic disorders according to medical records or Legal Guardian (LG) /parent report. Child has been diagnosed with congenital disease or genetic disorders such as atrial or ventricular wall defects, or Down's syndrome according to medical records or Legal Guardian (LG) /parent report. Child has been diagnosed with infantile anorexia nervosa according to medical records or Legal Guardian (LG) /parent report. Child has been diagnosed with a developmental disability, including physical disorders such as cerebral palsy, or developmental delay according to medical records or Legal Guardian (LG) /parent report. Child has been diagnosed with disorders of hemoglobin structure, function or synthesis according to medical records or Legal Guardian (LG) /parent report. Child has a clinically significant nutritional deficiency requiring specific treatment with another nutritional supplement (other than the study product) as diagnosed by the investigator. Child has any other clinically significant medical condition, which in the investigator's opinion, makes him or her unsuitable for inclusion in the study.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 4 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group 1:<br>Oral nutritional supplement (List No S691/Z0) and dietary counseling | Dietary Supplement: Oral nutritional supplement (List No S691/Z0)<br>* (List No S691/Z0)<br>Other: Dietary Counselling<br>* Regular dietary counseling conducted by a trained hospital dietitian.<br>|
| Experimental: Experimental Group 2<br>Oral nutritional supplement (List No- P968/Z0) and dietary counseling. | Dietary Supplement: Oral nutritional supplement<br>* (List No- P968/Z0)<br>Other: Dietary Counselling<br>* Regular dietary counseling conducted by a trained hospital dietitian.<br>|
| No Intervention: Control Group<br>Dietary Counselling only. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in WHO weight-for-height percentile |  | Day 1 to Day 90 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in weight-for-height WHO z-score |  | Day 1 to Day 90 | 
| Change in weight-for-age WHO z-score and percentile |  | Day 1 to Day 90 | 
| Change in height-for-age WHO z-score and percentile |  | Day 1 to Day 90 | 
| Change in BMI-for-age WHO z-score and percentile |  | Day 1 to Day 90 | 
| Change in Mid Upper Arm Circumference-for-age WHO z-score and percentile |  | Day 1 to Day 90 | 
| Average energy macronutrients (Carbohydrates, Fats, & Proteins) and micronutrients consumption via 24 hr dietary recall |  | Days 1, 7, 30, 60 and 90 | 
| Change in appetite score |  | Days 1, 7, 30, 60 and 90 | 
| Palatability scores for the oral nutritional supplements |  | Days 7, 30, 60 and 90 | 
| Change in weight-for-height WHO z-score and percentile |  | Day 1 to Day 90 | 
| Average energy macronutrients (Carbohydrates, Fats, & Proteins) and micronutrients consumption via 24 hr dietary recall |  | Day 1, 7, 30, 60 and 90 |