Nutritional Supplementation in Children at Risk of Undernutrition

Study Overview
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Brief Summary
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This is a prospective, multicenter, single-arm intervention study. The expected duration of study participation for each participant is approximately 120 days. The current study aims to investigate the effectiveness of an ONS formula in children at risk or with undernutrition in Thailand.

Official Title
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Effects of Oral Nutritional Supplementation in 12-71 Months Old Children at Risk of Undernutrition

Conditions
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Malnutrition, Child

Intervention / Treatment
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* Other: Oral Nutritional Supplement (ONS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Child is between 1 year 0 days to 5 years 364 days old at enrolment Undernourished or at risk of undernutrition, defined as: WHZ <- 1 and HAZ <-1 for children up to 4 years 364 days, according to the WHO Growth Standards; or BMIAZ <-1 and HAZ <-1 for children 5 years 0 days and older, according to the WHO Growth Reference Standards Child is not currently breastfed Child's parent(s)/LG is willing to abstain from giving additional non-study Oral Nutritional Supplement (ONS) other than the study product during the study intervention period Child is a singleton 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: Child 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 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 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: Severe gastrointestinal disorders such as celiac disease, short bowel syndrome, pancreatic insufficiency, or cystic fibrosis 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) 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: 1 Year
Maximum Age: 5 Years

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


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 Nutritional Supplement (ONS)<br>* ONS plus dietary counseling<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Height-for-age-Z-score | Change in Height-for-age-Z-score | Baseline to 120 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight | Measured in Kg | Baseline to 30 days and 120 days | 
| Height | Measured in cm | Baseline to 30 days and 120 days | 
| Mid-Upper-Arm Circumference (MUAC) | Measured in cm | Baseline to 30 days and 120 days | 
| Weight-for-Height Measurement Calculations | Weight-for-height standard z scores and percentiles | Baseline to 30 days and 120 days | 
| Weight-for-Age Measurement Calculations | Weight-for-age standard z scores and percentiles | Baseline to 30 days and 120 days | 
| BMI-for-Age Measurement Calculations | BMI-for-age standard z scores and percentiles | Baseline to 30 days and 120 days | 
| Height-for-Age Measurement Calculations | Height-for-age standard z scores and percentiles | Baseline to 30 days and 120 days | 
| MUAC-for-Age Measurement Calculations | MUAC-for-age standard z scores and percentiles | Baseline to 30 days and 120 days | 
| Dietary Intake | Measured by 24-hour dietary recall | Baseline to 30 days and 120 days | 
| Appetite | Visual analog scale from 0 (Ate Very Little) to 10 (Ate Very Much) with high scores being favorable | Baseline to 30 days and 120 days | 
| Physical Activity | Visual analog scale from 0 (Not Active) to 10 (Very Active) with high scores being favorable | Baseline to 30 days and120 days |