A Study of an Oral Nutrition Supplement (ONS) in Children.

Study Overview
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Brief Summary
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To assess the effect of oral nutritional supplementation with dietary counseling versus dietary counseling alone on growth of preschool children over a period of 90 days.

Official Title
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A Study of an Oral Nutrition Supplement (ONS) in Children.

Conditions
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Growth

Intervention / Treatment
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* Other: Nutrition supplement + dietary counseling
* Other: Dietary Counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age of 24-72 months (inclusive), both genders. Diagnosed with current acute upper respiratory tract infection. Weight-for-age between 3rd - 15th percentile according to WHO Growth Charts. Identified as a picky eater. Able to consume foods and beverages orally. Willing to abstain from additional non-study provided protein supplements or nutritional supplements throughout the study period. Exclusion Criteria: Current illness requiring hospitalization. Gastrointestinal infection and/or acute diarrhea at the time of inclusion in the study. Currently taking medication that could affect absorption/metabolism of study product or weight of the child. Diagnosed with recurrent respiratory infections due to cystic fibrosis, immunodeficiency syndromes, and congenital abnormalities of the respiratory tract, congenital lung and ciliary abnormalities, an unsuspected foreign body and asthma. Active tuberculosis, acute hepatitis B or C, or HIV, malignancy. History of diabetes mellitus. Received antibiotic therapy within the last two weeks before start of the study. Dysphagia, aspiration risk, difficulty in swallowing due to acquired / congenital abnormalities that would hamper oral intake of the study product. Clinically significant nutritional deficiency requiring specific treatment with any other nutritional supplement (not study product).

Ages Eligible for Study
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Minimum Age: 24 Months
Maximum Age: 72 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ONS + dietary counseling<br>ONS/day + dietary counseling | Other: Nutrition supplement + dietary counseling<br>* Nutritionally balanced nutritional supplement providing 1.0 kcal/ml.<br>* Other names: Commercially available nutritional supplement.;|
| Active Comparator: Dietary counseling<br>Dietary counseling | Other: Dietary Counseling<br>* Dietary counseling provided at each study visit by study dietitian.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight | Change in weight-for-age from Day 1 to Day 90 | Study Day (SD) 1 to 90 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory Infections | Number and duration of recurrent acute upper respiratory tract infections per month during the study period. | Study Day (SD) 1 to 90 | 
| Sick Days | Number of sick days per month assessed by the presence of any acute upper respiratory tract infections during the study period. | Study Day (SD) 1 to 90 | 
| Doctor Visits | Number of unscheduled visits per month due to development of acute upper respiratory tract infections during the study period. | Study Day (SD) 1 to 90 | 
| Dietary Intake | Average energy consumption (values and changes from baseline). | Study Day (SD) 1 to 90 | 
| Appetite Score | Change in appetite score (values and changes from baseline) | Study Day (SD) 3, 10, 30, 60 and 90 |