Effects of Oral Nutritional Supplementation With Dietary Counseling in 24-60 Months Old Children at Risk of Undernutrition

Abbott Nutrition1 site in 1 country330 target enrollmentJanuary 14, 2022

ConditionsUndernutrition

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Undernutrition
Sponsor: Abbott Nutrition
Enrollment: 330
Locations: 1
Primary Endpoint: Weight-for-Age Z-Score
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This prospective, randomized, controlled study will evaluate the effects of oral nutritional supplementation plus dietary counseling versus dietary counseling alone in children at nutritional risk.

Registry

clinicaltrials.gov

Start Date

January 14, 2022

End Date

December 18, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Abbott Nutrition

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Children 24-60 months old
•Undernourished or at risk of undernutrition according to the WHO Growth Standards.
•Child's parent(s)/legal guardian (LG) is willing to abstain from giving additional non-study ONS other than the study product during the study intervention period.
•Child's parent(s)/LG is able and willing to follow study procedures and record data in parent diary and complete any forms or assessments needed throughout the study.
•Child's parent(s)/LG is not planning to relocate during the study period.
•Child's parent(s)/LG has voluntarily signed and dated an Informed Consent Form (ICF), approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) or other applicable privacy regulation authorization prior to any participation in the study.

Exclusion Criteria

•Participant participates in another study that has not been approved as a concomitant study.
•Child is known to have galactosemia, be allergic or intolerant to any ingredient found in the study product.
•Child is currently drinking an Abbott product(s).
•Child had a history of preterm delivery, defined as a birth before 37 completed weeks of gestation as reported by parent(s)/LG.
•Child had birth weight \< 2500 g or \> 4000 g.
•Child whose either parent has BMI ≥ 27.5 kg/m2
•Child has continuous oral nutrition supplement (ONS) usage for at least 15 days in the past 1 month prior to screening. The standard ONS formula usually has an energy density of at least 1 kcal/mL, containing protein, carbohydrate and/or fat, as well as a wide range of micronutrients to supplement or use as the sole source of nutrition.
•Child has current acute or chronic infections including but not restricted to respiratory infections, diarrhea, acute and chronic Hepatitis B or C, HIV infection or tuberculosis.
•Child has been diagnosed with the following according to medical records or report by parent(s)/LG or the clinician's judgment:
•Severe gastrointestinal disorders such as celiac disease, short bowel syndrome, pancreatic insufficiency, or cystic (Exception: Intestinal parasites infection)