A Study of an Oral Nutrition Supplement (ONS) in Children.
|ClinicalTrials.gov Identifier: NCT02056275|
Recruitment Status : Completed
First Posted : February 5, 2014
Last Update Posted : March 6, 2015
|Condition or disease||Intervention/treatment||Phase|
|Growth||Other: Nutrition supplement + dietary counseling Other: Dietary Counseling||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||256 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study of an Oral Nutrition Supplement (ONS) in Children.|
|Study Start Date :||August 2013|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||April 2014|
Experimental: ONS + dietary counseling
ONS/day + dietary counseling
Other: Nutrition supplement + dietary counseling
Nutritionally balanced nutritional supplement providing 1.0 kcal/ml.
Other Name: Commercially available nutritional supplement.
Active Comparator: Dietary counseling
Other: Dietary Counseling
Dietary counseling provided at each study visit by study dietitian.
- Weight [ Time Frame: Study Day (SD) 1 to 90 ]Change in weight-for-age from Day 1 to Day 90
- Respiratory Infections [ Time Frame: Study Day (SD) 1 to 90 ]Number and duration of recurrent acute upper respiratory tract infections per month during the study period.
- Sick Days [ Time Frame: 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.
- Doctor Visits [ Time Frame: 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.
- Dietary Intake [ Time Frame: Study Day (SD) 1 to 90 ]Average energy consumption (values and changes from baseline).
- Appetite Score [ Time Frame: Study Day (SD) 3, 10, 30, 60 and 90 ]Change in appetite score (values and changes from baseline)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02056275
|St. Theresa's Hospital|
|Hyderabad, Andhra Pradesh, India, 500018|
|Praveen Cardiac Centre|
|Vijayawada, Andhra Pradesh, India, 520002|
|Ahmedabad, Gujarat, India, 380006|
|Kasturba Medical College and Hospital|
|Manipal, Karnataka, India, 567104|
|Pune, Maharashtra, India, 411013|
|Seth GS Medical College and KEM Hospital|
|Mumbai-12, Mumbai, India|
|Institute of Child Health|
|Kolkata, West Bengal, India, 700 017|
|TN Medical College & BYL Nair Hospital|
|Mumbai, India, 400 008|
|Study Chair:||Vinita Satyavrat, MD||Abbott Nutrition|