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

Not Applicable

Completed

• Conditions: Growth
• Interventions: Other: Nutrition supplement + dietary counseling; Other: Dietary Counseling

• Registration Number: NCT02056275
• Lead Sponsor: Abbott Nutrition

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2014-02-04
• Study First Submitted QC: 2014-02-04
• Study First Posted: 2014-02-05
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2014-10
• Last Update Submitted: 2015-03-05
• Last Update Posted: 2015-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 256

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ONS + dietary counseling	Nutrition supplement + dietary counseling	ONS/day + dietary counseling
Dietary counseling	Dietary Counseling	Dietary counseling

Primary Outcome Measures

Name	Time	Method
Weight	Study Day (SD) 1 to 90	Change in weight-for-age from Day 1 to Day 90

Secondary Outcome Measures

Name	Time	Method
Sick Days	Study Day (SD) 1 to 90	Number of sick days per month assessed by the presence of any acute upper respiratory tract infections during the study period.
Dietary Intake	Study Day (SD) 1 to 90	Average energy consumption (values and changes from baseline).
Doctor Visits	Study Day (SD) 1 to 90	Number of unscheduled visits per month due to development of acute upper respiratory tract infections during the study period.
Respiratory Infections	Study Day (SD) 1 to 90	Number and duration of recurrent acute upper respiratory tract infections per month during the study period.
Appetite Score	Study Day (SD) 3, 10, 30, 60 and 90	Change in appetite score (values and changes from baseline)

Trial Locations

Locations (8)

Praveen Cardiac Centre; 🇮🇳 Vijayawada, Andhra Pradesh, India

Sangini Hospital; 🇮🇳 Ahmedabad, Gujarat, India

St. Theresa's Hospital; 🇮🇳 Hyderabad, Andhra Pradesh, India

Seth GS Medical College and KEM Hospital; 🇮🇳 Mumbai-12, Mumbai, India

Institute of Child Health; 🇮🇳 Kolkata, West Bengal, India

Kasturba Medical College and Hospital; 🇮🇳 Manipal, Karnataka, India

Noble Hospital; 🇮🇳 Pune, Maharashtra, India

TN Medical College & BYL Nair Hospital; 🇮🇳 Mumbai, India