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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Nutritional Supplement (ONS) Group | Experimental | Two servings per day in addition to dietary counseling |
|
| Control Group | Active Comparator | Dietary counseling |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Nutrition Supplement (ONS) Group | Other | Oral nutritional supplement specifically designed for nutritionally-at risk children and dietary counseling |
|
| Measure | Description | Time Frame |
|---|---|---|
| Weight-for-Age Z-Score | Change in weight-for-age z-score | Baseline to 120 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Weight | Measured in Kg | Baseline to 240 Days |
| Height | Measured in cm | Baseline to 240 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Body Composition | Measured by duel-energy x-ray absorptiometry | Baseline to 240 Days |
| Bone Quality | Measured by duel-energy x-ray absorptiometry |
Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Yen Ling Mandy Ow, PhD | Abbott | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institute of Nutrition | HÃ Ná»™i | 11611 | Vietnam |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40660276 | Derived | Ow MYL, Tran NT, Berde Y, Nguyen TS, Tran VK, Jablonka MJ, Baggs GE, Huynh DTT. Efficacy of long-term oral nutritional supplementation with dietary counseling on growth, body composition and bone mineralization in children with or at risk for undernutrition: a randomized controlled trial. Nutr J. 2025 Jul 14;24(1):110. doi: 10.1186/s12937-025-01133-5. |
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| ID | Term |
|---|---|
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D044382 | Population Groups |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D003710 | Demography |
| D011154 | Population Characteristics |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
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| Control Group | Other | Dietary counseling |
|
| 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 |
| Baseline to 240 Days |
| Lower Leg Length | Measured in cm | Baseline to 240 Days |
| Adverse Event Reporting | Parent reported adverse events | Baseline to 240 Days |
| Healthcare Utilization | Number of sick days, healthcare visits, missed days school, missed days work | Baseline to 240 Days |
| Physical Activity | Visual analog scale Not Active to Very Active | Baseline to 240 Days |
| Child's Healthy Growth | Parent completed assessment of child's growth | Baseline to 240 Days |
| Product Palatability | 1, 5-point scale from Dislike it very much to Like to very much | Study Day 1 to Study Day 240 |
| Child's Sleep Assessment | Parent reported sleep habits | Baseline to 240 Days |
| Early Childhood Behavior Questionnaire | 6, 7-point Likert scale questions scored from Never to Always | Baseline to 240 Days |
| Blood Biomarkers Amino Acid | Blood chemistry analysis of amino acid biomarkers | Baseline to 240 Days |
| Blood Biomarkers Bone | Blood chemistry analysis of bone biomarkers | Baseline to 240 Days |
| Hand Grip Strength | Measured in kg | Baseline to 240 Days |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |