Undernutrition
Conditions
Brief summary
The objective of this randomized, controlled trial is to evaluate the effects of consuming a pediatric oral nutritional supplement (ONS) plus dietary counseling for 120 days on anthropometric growth, strength, and nutritional status, compared with dietary counseling alone in undernourished children in the United States.
Interventions
OTHEROral Nutritional Supplement
ONS plus dietary counseling
OTHERDietary counseling
dietary counseling
Sponsors
Abbott Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
36 Months to 107 Months
Healthy volunteers
No
Inclusion criteria
* Child is 36 months - 107 months of age. * Child is undernourished as determined by BMI for age z-score or Mid-upper-arm circumference z-score * Child's caregiver has voluntarily signed and dated an informed consent form (ICF), approved by an IRB, and provided Health Insurance Portability and Accountability Act (HIPAA) or other applicable privacy regulation authorization prior to any participation in the study. * Child's caregiver is willing to abstain from providing non-study oral nutrition supplements during the study period duration. * Child's caregiver is able and willing to follow study procedures and record data in parent diaries and complete any forms or assessments needed during the study. * Child is willing to consume the study product for the duration of the study, if randomized to intervention group
Exclusion criteria
* Child has a height-for-age z-score ≥ 0. * Child is currently drinking an oral nutritional supplement (ONS) on a regular basis (≥ 15 days in the past month) * Child is participating in another study that has not been approved as a concomitant study by AN. * Child has been diagnosed with the following: * Galactosemia, or an allergy or intolerance to any ingredient found in the study product * Acute or chronic infections including but not restricted to respiratory infections, diarrhea, Hepatitis B or C, HIV infection or tuberculosis * Severe gastrointestinal disorders such as celiac disease, short bowel syndrome, pancreatic insufficiency, or cystic fibrosis * Neoplastic, renal, hepatic or cardiovascular, hormonal or metabolic disorders, Down's syndrome or significant, uncorrected cardiac anomalies that may impact growth * Infantile anorexia nervosa, developmental disability, including physical disorders such as cerebral palsy, or a developmental delay that is considered too severe for participation * Disorders of hemoglobin structure, function or synthesis * Clinically significant nutritional deficiency requiring specialty nutritional therapy * 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 (WAZ) | baseline to 120 days | Change in weight-for-age z-score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mid-upper-arm circumference (MUAC) | baseline to 120 days | Measured in cm |
| Weight | baseline to 120 days | Measured in Kg |
| Anthropometric Measurement Calculations | baseline to 120 days | Standard z-scores and percentiles including weight-for-age, height-for-age, weight-for-height, BMI-for-age and mid-upper-arm-circumference-for-age |
| Dietary Diversity | baseline to 120 days | Measured by 24-hour dietary recall |
| Appetite | baseline to 120 days | Visual analog scale from Ate Very Little to Ate A Lot |
| Height | baseline to 120 days | Measured in cm |
Other
| Measure | Time frame | Description |
|---|---|---|
| Parental Stress Scale | baseline to 120 days | 18 questions scaled from Strongly disagree to Strongly Agree |
| Child Eating Behavior Questionnaire | baseline to 120 days | 35 questions 5-Point Likert Scale from Never to Always |
| Hand Grip Strength | baseline to 120 days | Measured in kg |
| Children's Sleep Habit Questionnaire | baseline to 120 days | 7 Parent reported questions related to child's sleep habits |
| Triceps Skinfold | baseline to 120 days | Measured in mm |
| Caregiver Opinion Questionnaire | baseline to 120 days | 3 Parent reported questions related to child's nutrition |
| Nutrition Biomarkers | baseline to 120 days | Blood chemistry analysis of vitamin A, vitamin B12, vitamin D, vitamin E, folate, and vitamin K |
| Adverse Event Reporting | baseline to 120 days | Standard adverse event reporting |
| Health Care Utilization | baseline to 120 days | Number of unscheduled visits or missed school days (child) or work days (parent) |
| Sleep Data | baseline to 120 days | Average daily number of hours |
| Activity Data | baseline to 120 days | Average daily number of minutes |
| Physical Activity | baseline to 120 days | Visual analog scale from Not Active to Very Active |
Countries
United States
Outcome results
None listed