Oral Nutritional Supplementation in Children at Risk of Undernutrition

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Oral Nutritional Supplementation With Dietary Counseling in Children at Risk of Undernutrition

Conditions
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Undernutrition

Intervention / Treatment
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* Other: Oral Nutritional Supplement
* Other: Dietary counseling


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 36 Months
Maximum Age: 107 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 Nutritional Supplement<br>* ONS plus dietary counseling<br>Other: Dietary counseling<br>* dietary counseling<br>|
| Other: Control Group<br>dietary counseling | Other: Dietary counseling<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 (WAZ) | Change in weight-for-age z-score | baseline to 120 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anthropometric Measurement Calculations | 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 | baseline to 120 days | 
| Mid-upper-arm circumference (MUAC) | Measured in cm | baseline to 120 days | 
| Weight | Measured in Kg | baseline to 120 days | 
| Height | Measured in cm | baseline to 120 days | 
| Dietary Diversity | Measured by 24-hour dietary recall | baseline to 120 days | 
| Appetite | Visual analog scale from Ate Very Little to Ate A Lot | baseline to 120 days |