Oral Nutritional Supplementation in Children at Risk of Undernutrition
NCT ID: NCT05161000
Last Updated: 2024-07-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
279 participants
INTERVENTIONAL
2022-04-18
2024-06-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Oral Nutritional Supplement (ONS) Group
Two servings per day in addition to dietary counseling
Oral Nutritional Supplement
ONS plus dietary counseling
Dietary counseling
dietary counseling
Control Group
dietary counseling
Dietary counseling
dietary counseling
Interventions
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Oral Nutritional Supplement
ONS plus dietary counseling
Dietary counseling
dietary counseling
Eligibility Criteria
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Inclusion Criteria
* 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 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.
36 Months
107 Months
ALL
No
Sponsors
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Abbott Nutrition
INDUSTRY
Responsible Party
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Principal Investigators
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Jennifer Williams, MPH
Role: STUDY_CHAIR
Abbott Nutrition
Locations
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Midway Medical Clinic
Oneonta, Alabama, United States
HealthStar Research Glenwood
Glenwood, Arkansas, United States
HealthStar Research, LLC
Hot Springs, Arkansas, United States
L.A. Universal Research Center, Inc.
Los Angeles, California, United States
Kissimmee Clinical Research
Kissimmee, Florida, 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
Springs Medical Research
Owensboro, Kentucky, United States
Velocity Clinical Research
Covington, Louisiana, United States
Southern Clinical Research
Zachary, Louisiana, United States
Alivation Research (Primary Care)
Lincoln, Nebraska, United States
Javara Inc. 3380
Winston-Salem, North Carolina, United States
Tribe Clinical Research LLC.
Greenville, South Carolina, United States
Javara, Inc. 3377
Dallas, Texas, United States
Proactive Clinical Research
Edinburg, Texas, United States
Gentle Pediatrics
Sugar Land, Texas, United States
Countries
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Other Identifiers
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AL48
Identifier Type: -
Identifier Source: org_study_id
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