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

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.

Study Overview

• Status: Completed
• Conditions: Growth
• Intervention / Treatment: Other: Nutrition supplement + dietary counseling; Other: Dietary Counseling

• Study Type: Interventional
• Enrollment (Actual): 256
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Mumbai, India, 400 008
    • TN Medical College & BYL Nair Hospital
  • Andhra Pradesh
    • Hyderabad, Andhra Pradesh, India, 500018
      • St. Theresa's Hospital
    • Vijayawada, Andhra Pradesh, India, 520002
      • Praveen Cardiac Centre
  • Gujarat
    • Ahmedabad, Gujarat, India, 380006
      • Sangini Hospital
  • Karnataka
    • Manipal, Karnataka, India, 567104
      • Kasturba Medical College and Hospital
  • Maharashtra
    • Pune, Maharashtra, India, 411013
      • Noble Hospital
  • Mumbai
    • Mumbai-12, Mumbai, India
      • Seth GS medical college and KEM Hospital
  • West Bengal
    • Kolkata, West Bengal, India, 700 017
      • Institute of Child Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 6 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ONS + dietary counseling; ONS/day + dietary counseling	Other: Nutrition supplement + dietary counseling; Nutritionally balanced nutritional supplement providing 1.0 kcal/ml.; Other Names: Commercially available nutritional supplement.
ACTIVE_COMPARATOR: Dietary counseling	Other: Dietary Counseling; Dietary counseling provided at each study visit by study dietitian.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	Change in weight-for-age from Day 1 to Day 90	Study Day (SD) 1 to 90

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Abbott Nutrition
• Investigators: Study Chair: Vinita Satyavrat, MD, Abbott Nutrition

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (ACTUAL): April 1, 2014
• Study Completion (ACTUAL): April 1, 2014

Study Registration Dates

• First Submitted: February 4, 2014
• First Submitted That Met QC Criteria: February 4, 2014
• First Posted (ESTIMATE): February 5, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): March 6, 2015
• Last Update Submitted That Met QC Criteria: March 5, 2015
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: DA01