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

Abbott Nutrition17 sites in 1 country279 target enrollmentApril 18, 2022

ConditionsUndernutrition

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Undernutrition
Sponsor: Abbott Nutrition
Enrollment: 279
Locations: 17
Primary Endpoint: Weight-for-age z-score (WAZ)
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 18, 2022

End Date

June 11, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Abbott Nutrition

Responsible Party

Sponsor

Eligibility Criteria

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 ≥
•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