Oral Nutritional Supplementation in Children at Risk of Undernutrition
- Conditions
- Undernutrition
- Interventions
- Other: Dietary counselingOther: Oral Nutritional Supplement
- Registration Number
- NCT05161000
- Lead Sponsor
- Abbott Nutrition
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 279
- 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
-
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Group Dietary counseling dietary counseling Oral Nutritional Supplement (ONS) Group Oral Nutritional Supplement Two servings per day in addition to dietary counseling Oral Nutritional Supplement (ONS) Group Dietary counseling Two servings per day in addition to dietary counseling
- Primary Outcome Measures
Name Time Method Weight-for-age z-score (WAZ) baseline to 120 days Change in weight-for-age z-score
- Secondary Outcome Measures
Name Time Method Appetite baseline to 120 days Visual analog scale from Ate Very Little to Ate A Lot
Mid-upper-arm circumference (MUAC) baseline to 120 days Measured in cm
Height baseline to 120 days Measured in cm
Dietary Diversity baseline to 120 days Measured by 24-hour dietary recall
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
Weight baseline to 120 days Measured in Kg
Trial Locations
- Locations (17)
Javara, Inc. 3377
🇺🇸Dallas, Texas, United States
L.A. Universal Research Center, Inc.
🇺🇸Los Angeles, California, United States
Springs Medical Research
🇺🇸Owensboro, Kentucky, United States
Dade Research Center, LLC
🇺🇸Miami, Florida, United States
D&H National Research Centers
🇺🇸Miami, Florida, United States
Suncoast Research, Assoc., LLC
🇺🇸Miami, Florida, United States
Midway Medical Clinic
🇺🇸Oneonta, Alabama, United States
HealthStar Research Glenwood
🇺🇸Glenwood, Arkansas, United States
HealthStar Research, LLC
🇺🇸Hot Springs, Arkansas, United States
Kissimmee Clinical Research
🇺🇸Kissimmee, Florida, United States
Velocity Clinical Research
🇺🇸Covington, Louisiana, United States
Southern Clinical Research
🇺🇸Zachary, Louisiana, United States
Alivation Research (Primary Care)
🇺🇸Lincoln, Nebraska, United States
Tribe Clinical Research LLC.
🇺🇸Greenville, South Carolina, United States
Javara Inc. 3380
🇺🇸Winston-Salem, North Carolina, United States
Proactive Clinical Research
🇺🇸Edinburg, Texas, United States
Gentle Pediatrics
🇺🇸Sugar Land, Texas, United States