Effects of Oral Nutritional Supplementation in Children at Risk of Undernutrition

Study Overview
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Brief Summary
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This prospective, randomized, controlled study will evaluate the effects of oral nutritional supplementation plus dietary counseling versus dietary counseling alone in children at nutritional risk.

Official Title
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Effects of Oral Nutritional Supplementation With Dietary Counseling in 24-60 Months Old Children at Risk of Undernutrition

Conditions
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Undernutrition

Intervention / Treatment
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* Other: Oral Nutrition Supplement (ONS) Group
* Other: Control Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children 24-60 months old Undernourished or at risk of undernutrition according to the WHO Growth Standards. Child's parent(s)/legal guardian (LG) is willing to abstain from giving additional non-study ONS other than the study product during the study intervention period. Child's parent(s)/LG 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 parent(s)/LG is not planning to relocate during the study period. Child's parent(s)/LG has voluntarily signed and dated an Informed Consent Form (ICF), approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) or other applicable privacy regulation authorization prior to any participation in the study. Exclusion Criteria: Participant participates in another study that has not been approved as a concomitant study. Child is known to have galactosemia, be allergic or intolerant to any ingredient found in the study product. Child is currently drinking an Abbott product(s). Child had a history of preterm delivery, defined as a birth before 37 completed weeks of gestation as reported by parent(s)/LG. Child had birth weight < 2500 g or > 4000 g. Child whose either parent has BMI ≥ 27.5 kg/m2 Child has continuous oral nutrition supplement (ONS) usage for at least 15 days in the past 1 month prior to screening. The standard ONS formula usually has an energy density of at least 1 kcal/mL, containing protein, carbohydrate and/or fat, as well as a wide range of micronutrients to supplement or use as the sole source of nutrition. Child has current acute or chronic infections including but not restricted to respiratory infections, diarrhea, acute and chronic Hepatitis B or C, HIV infection or tuberculosis. Child has been diagnosed with the following according to medical records or report by parent(s)/LG or the clinician's judgment: Severe gastrointestinal disorders such as celiac disease, short bowel syndrome, pancreatic insufficiency, or cystic (Exception: Intestinal parasites infection) Neoplastic, renal, hepatic or cardiovascular, hormonal or metabolic disorders, congenital disease or genetic disorders such as atrial or ventricular wall defects, Down's syndrome, or thalassemia Infantile anorexia nervosa, developmental disability, including physical disorders such as cerebral palsy, or developmental delay Disorders of hemoglobin structure, function or synthesis Clinically significant nutritional deficiency requiring specific treatment with another nutritional supplement (other than the study product) as diagnosed by the investigator. 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
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Minimum Age: 24 Months
Maximum Age: 60 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

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral Nutritional Supplement (ONS) Group<br>Two servings per day in addition to dietary counseling | Other: Oral Nutrition Supplement (ONS) Group<br>* Oral nutritional supplement specifically designed for nutritionally-at risk children and dietary counseling<br>|
| Active Comparator: Control Group<br>Dietary counseling | Other: Control Group<br>* Dietary counseling<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight-for-Age Z-Score | Change in weight-for-age z-score | Baseline to 120 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight | Measured in Kg | Baseline to 240 Days | 
| Height | Measured in cm | Baseline to 240 Days | 
| Mid-Upper-Arm Circumference (MUAC) | Measured in cm | Baseline to 240 Days | 
| Weight-for-Height Measurement Calculations | Weight-for-height standard z-scores and percentiles | Baseline to 240 Days | 
| BMI-for-Age Measurement Calculations | BMI-for-age standard z-scores and percentiles | Baseline to 240 Days | 
| Height-for-Age Measurement Calculations | Height-for-age standard z-scores and percentiles | Baseline to 240 Days | 
| MUAMC Measurement Calculations | Mid-upper-arm-circumference-for-age standard z-scores and percentiles | Baseline to 240 Days | 
| Dietary Intake | Measured by 24-hour dietary recall | Baseline to 240 Days | 
| Appetite | Visual analog scale from Ate Very Little to Ate Very Much | Baseline to 240 Days |