Clinical trial NCT02056275: A Study of an Oral Nutrition Supplement (ONS) in Children.
Official title: A Study of an Oral Nutrition Supplement (ONS) in Children.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Growth
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2014-02-05
Enrollment: 256
Sex: ALL
Minimum age (years): 24
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Weight
timeFrame: Study Day (SD) 1 to 90
Secondary outcomes:
measure: Respiratory Infections
timeFrame: Study Day (SD) 1 to 90
measure: Sick Days
timeFrame: Study Day (SD) 1 to 90
measure: Doctor Visits
timeFrame: Study Day (SD) 1 to 90
measure: Dietary Intake
timeFrame: Study Day (SD) 1 to 90
measure: Appetite Score
timeFrame: Study Day (SD) 3, 10, 30, 60 and 90
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: St. Theresa's Hospital
state: Andhra Pradesh
city: Vijayawada
country: India
facility: Praveen Cardiac Centre
state: Andhra Pradesh
city: Ahmedabad
country: India
facility: Sangini Hospital
state: Gujarat
city: Manipal
country: India
facility: Kasturba Medical College and Hospital
state: Karnataka
city: Pune
country: India
facility: Noble Hospital
state: Maharashtra
city: Mumbai-12
country: India
facility: Seth GS Medical College and KEM Hospital
state: Mumbai
city: Kolkata
country: India
facility: Institute of Child Health
state: West Bengal
city: Mumbai
country: India
facility: TN Medical College & BYL Nair Hospital
Study officials:
affiliation: Abbott Nutrition
name: Vinita Satyavrat, MD
role: STUDY_CHAIR
References: