Oral Nutritional Supplementation in Children at Risk of Undernutrition
Effects of Oral Nutritional Supplementation With Dietary Counseling in Children at Risk of Undernutrition
1 other identifier
interventional
279
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2022
Typical duration for not_applicable
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 3, 2021
CompletedFirst Posted
Study publicly available on registry
December 16, 2021
CompletedStudy Start
First participant enrolled
April 18, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 11, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 11, 2024
CompletedJuly 16, 2024
July 1, 2024
2.2 years
December 3, 2021
July 14, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Weight-for-age z-score (WAZ)
Change in weight-for-age z-score
baseline to 120 days
Secondary Outcomes (6)
Anthropometric Measurement Calculations
baseline to 120 days
Mid-upper-arm circumference (MUAC)
baseline to 120 days
Weight
baseline to 120 days
Height
baseline to 120 days
Dietary Diversity
baseline to 120 days
- +1 more secondary outcomes
Other Outcomes (12)
Hand Grip Strength
baseline to 120 days
Nutrition Biomarkers
baseline to 120 days
Adverse Event Reporting
baseline to 120 days
- +9 more other outcomes
Study Arms (2)
Oral Nutritional Supplement (ONS) Group
EXPERIMENTALTwo servings per day in addition to dietary counseling
Control Group
OTHERdietary counseling
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbott Nutritionlead
Study Sites (17)
Midway Medical Clinic
Oneonta, Alabama, 35121, United States
HealthStar Research Glenwood
Glenwood, Arkansas, 71943, United States
HealthStar Research, LLC
Hot Springs, Arkansas, 71913, United States
L.A. Universal Research Center, Inc.
Los Angeles, California, 90057, United States
Kissimmee Clinical Research
Kissimmee, Florida, 34743, United States
Dade Research Center, LLC
Miami, Florida, 33126, United States
D&H National Research Centers
Miami, Florida, 33155, United States
Suncoast Research, Assoc., LLC
Miami, Florida, 33173, United States
Springs Medical Research
Owensboro, Kentucky, 42303, United States
Velocity Clinical Research
Covington, Louisiana, 70433, United States
Southern Clinical Research
Zachary, Louisiana, 70791, United States
Alivation Research (Primary Care)
Lincoln, Nebraska, 68526, United States
Javara Inc. 3380
Winston-Salem, North Carolina, 27103, United States
Tribe Clinical Research LLC.
Greenville, South Carolina, 29607, United States
Javara, Inc. 3377
Dallas, Texas, 75230, United States
Proactive Clinical Research
Edinburg, Texas, 78539, United States
Gentle Pediatrics
Sugar Land, Texas, 77479, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jennifer Williams, MPH
Abbott Nutrition
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 3, 2021
First Posted
December 16, 2021
Study Start
April 18, 2022
Primary Completion
June 11, 2024
Study Completion
June 11, 2024
Last Updated
July 16, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share