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

Growth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02056275
• Other study ID #: DA01
• Status: Completed
• Phase: N/A
• First received: February 4, 2014
• Last updated: March 5, 2015
• Start date: August 2013
• Est. completion date: April 2014

Study information

• Verified date: October 2014
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 256
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 24 Months to 72 Months

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Growth

Intervention

Other:
• Nutrition supplement + dietary counseling
Nutritionally balanced nutritional supplement providing 1.0 kcal/ml.
• Dietary Counseling
Dietary counseling provided at each study visit by study dietitian.

Locations

Country	Name	City	State
India	Sangini Hospital	Ahmedabad	Gujarat
India	St. Theresa's Hospital	Hyderabad	Andhra Pradesh
India	Institute of Child Health	Kolkata	West Bengal
India	Kasturba Medical College and Hospital	Manipal	Karnataka
India	TN Medical College & BYL Nair Hospital	Mumbai
India	Seth GS Medical College and KEM Hospital	Mumbai-12	Mumbai
India	Noble Hospital	Pune	Maharashtra
India	Praveen Cardiac Centre	Vijayawada	Andhra Pradesh

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight	Change in weight-for-age from Day 1 to Day 90	Study Day (SD) 1 to 90	No
Secondary	Respiratory Infections	Number and duration of recurrent acute upper respiratory tract infections per month during the study period.	Study Day (SD) 1 to 90	No
Secondary	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	No
Secondary	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	No
Secondary	Dietary Intake	Average energy consumption (values and changes from baseline).	Study Day (SD) 1 to 90	No
Secondary	Appetite Score	Change in appetite score (values and changes from baseline)	Study Day (SD) 3, 10, 30, 60 and 90	No