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

Abbott

Status: Completed

Conditions: Growth

Treatments: Other: Dietary Counseling; Other: Nutrition supplement + dietary counseling

Study type: Interventional

Funder types: Industry

Identifiers

NCT02056275

DA01

Details and patient eligibility

About

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.

Enrollment: 256 patients

Sex: All

Ages: 24 to 72 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Current illness requiring hospitalization.
2. Gastrointestinal infection and/or acute diarrhea at the time of inclusion in the study.
3. Currently taking medication that could affect absorption/metabolism of study product or weight of the child.
4. 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.
5. Active tuberculosis, acute hepatitis B or C, or HIV, malignancy.
6. History of diabetes mellitus.
7. Received antibiotic therapy within the last two weeks before start of the study.
8. Dysphagia, aspiration risk, difficulty in swallowing due to acquired / congenital abnormalities that would hamper oral intake of the study product.
9. Clinically significant nutritional deficiency requiring specific treatment with any other nutritional supplement (not study product).

Trial design

256 participants in 2 patient groups

ONS + dietary counseling

Experimental group

Description:

ONS/day + dietary counseling

Treatment:

Other: Nutrition supplement + dietary counseling

Dietary counseling

Active Comparator group

Description:

Dietary counseling

Treatment:

Other: Dietary Counseling