Undernutrition
Conditions
Brief summary
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.
Interventions
OTHEROral Nutrition Supplement (ONS) Group
Oral nutritional supplement specifically designed for nutritionally-at risk children and dietary counseling
OTHERControl Group
Dietary counseling
Sponsors
Abbott Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
24 Months to 60 Months
Healthy volunteers
No
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: 1. Severe gastrointestinal disorders such as celiac disease, short bowel syndrome, pancreatic insufficiency, or cystic (Exception: Intestinal parasites infection) 2. 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 3. Infantile anorexia nervosa, developmental disability, including physical disorders such as cerebral palsy, or developmental delay 4. Disorders of hemoglobin structure, function or synthesis 5. Clinically significant nutritional deficiency requiring specific treatment with another nutritional supplement (other than the study product) as diagnosed by the investigator. 6. Any other clinically significant medical condition, which in the investigator's opinion, makes him or her unsuitable for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight-for-Age Z-Score | Baseline to 120 Days | Change in weight-for-age z-score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Height | Baseline to 240 Days | Measured in cm |
| Mid-Upper-Arm Circumference (MUAC) | Baseline to 240 Days | Measured in cm |
| Weight-for-Height Measurement Calculations | Baseline to 240 Days | Weight-for-height standard z-scores and percentiles |
| BMI-for-Age Measurement Calculations | Baseline to 240 Days | BMI-for-age standard z-scores and percentiles |
| Weight | Baseline to 240 Days | Measured in Kg |
| MUAMC Measurement Calculations | Baseline to 240 Days | Mid-upper-arm-circumference-for-age standard z-scores and percentiles |
| Dietary Intake | Baseline to 240 Days | Measured by 24-hour dietary recall |
| Appetite | Baseline to 240 Days | Visual analog scale from Ate Very Little to Ate Very Much |
| Height-for-Age Measurement Calculations | Baseline to 240 Days | Height-for-age standard z-scores and percentiles |
Other
| Measure | Time frame | Description |
|---|---|---|
| Blood Biomarkers Amino Acid | Baseline to 240 Days | Blood chemistry analysis of amino acid biomarkers |
| Body Composition | Baseline to 240 Days | Measured by duel-energy x-ray absorptiometry |
| Hand Grip Strength | Baseline to 240 Days | Measured in kg |
| Blood Biomarkers Bone | Baseline to 240 Days | Blood chemistry analysis of bone biomarkers |
| Bone Quality | Baseline to 240 Days | Measured by duel-energy x-ray absorptiometry |
| Lower Leg Length | Baseline to 240 Days | Measured in cm |
| Adverse Event Reporting | Baseline to 240 Days | Parent reported adverse events |
| Healthcare Utilization | Baseline to 240 Days | Number of sick days, healthcare visits, missed days school, missed days work |
| Physical Activity | Baseline to 240 Days | Visual analog scale Not Active to Very Active |
| Child's Healthy Growth | Baseline to 240 Days | Parent completed assessment of child's growth |
| Product Palatability | Study Day 1 to Study Day 240 | 1, 5-point scale from Dislike it very much to Like to very much |
| Child's Sleep Assessment | Baseline to 240 Days | Parent reported sleep habits |
| Early Childhood Behavior Questionnaire | Baseline to 240 Days | 6, 7-point Likert scale questions scored from Never to Always |
Countries
Vietnam
Outcome results
None listed