A Study of an Oral Nutrition Supplement (ONS) in Children.

Abbott Nutrition8 sites in 1 country256 target enrollmentAugust 2013

ConditionsGrowth

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Growth
Sponsor: Abbott Nutrition
Enrollment: 256
Locations: 8
Primary Endpoint: Weight
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To assess the effect of oral nutritional supplementation with dietary counseling versus dietary counseling alone on growth of preschool children over a period of 90 days.

Registry

clinicaltrials.gov

Start Date

August 2013

End Date

April 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Abbott Nutrition

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age of 24-72 months (inclusive), both genders.
•Diagnosed with current acute upper respiratory tract infection.
•Weight-for-age between 3rd - 15th percentile according to WHO Growth Charts.
•Identified as a picky eater.
•Able to consume foods and beverages orally.
•Willing to abstain from additional non-study provided protein supplements or nutritional supplements throughout the study period.

Exclusion Criteria

•Current illness requiring hospitalization.
•Gastrointestinal infection and/or acute diarrhea at the time of inclusion in the study.
•Currently taking medication that could affect absorption/metabolism of study product or weight of the child.
•Diagnosed with recurrent respiratory infections due to cystic fibrosis, immunodeficiency syndromes, and congenital abnormalities of the respiratory tract, congenital lung and ciliary abnormalities, an unsuspected foreign body and asthma.
•Active tuberculosis, acute hepatitis B or C, or HIV, malignancy.
•History of diabetes mellitus.
•Received antibiotic therapy within the last two weeks before start of the study.
•Dysphagia, aspiration risk, difficulty in swallowing due to acquired / congenital abnormalities that would hamper oral intake of the study product.
•Clinically significant nutritional deficiency requiring specific treatment with any other nutritional supplement (not study product).