A study of an oral nutrition supplement (ONS) in childre
- Conditions
- Health Condition 1: null- Acute URTI in children
- Registration Number
- CTRI/2014/07/004717
- Lead Sponsor
- Abbott Nutrition International India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 256
Subject
1.Is an age of 24-72 months (inclusive)(both gender)
2.Identified as having current acute upper respiratory tract infection
3.Has a weight-for-age between 3rd â?? 15th percentile according to WHO Growth Charts
4.Indentified as a picky eater
5.Is able to consume foods and beverages orally
6.Is willing to abstain from additional non-study provided protein supplements or nutritional supplements throughout the study period
Subject
1.Has a known allergy or intolerance to the study product or ingredients or is on a special diet and cannot consume the study product.
2.Has a current illness requiring hospitalization.
3.Has a gastrointestinal infection and/or acute diarrhea at the time of inclusion in the study
4.Is currently taking medication that could affect absorption/metabolism of study product or weight of the child. Exception: Topical/ocular steroids will be permitted during the study
5.Is 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. (as per history and documentation in the medical records).
6.has active tuberculosis, acute hepatitis B or C or HIV, malignancy (as per history and documentation in the medical records)
7.Has a history of diabetes mellitus (as per history and documentation in the medical records)
8.has been on antibiotic therapy within the last two weeks before start of the study (before study Day 1)
9.Has dysphagia, aspiration risk, difficulty in swallowing due to acquired / congenital abnormalities that would hamper oral intake of the study product. (as per history and documentation in the medical records)
10.Has a clinically significant nutritional deficiency requiring specific treatment with any other nutritional supplement (not study product) as diagnosed by the investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method change in weight-for-age WHO z-score from Day 1 to Day 90Timepoint: from Day 1 to Day 90
- Secondary Outcome Measures
Name Time Method 1.Change in weight-for-age WHO percentile <br/ ><br>2.No. of recurrent acute URI per month during the study period. <br/ ><br>3.No. of sick days per month assessed by the presence of any acute URTI during the study period. <br/ ><br>4.No.of unscheduled visits per month due to development of acute URI during the study period. <br/ ><br>5.No.of days required to recover from current episode of infection <br/ ><br>6.Avg.energy consumption <br/ ><br>7.Avg.energy consumption during period illness. <br/ ><br>8.Change in appetite score <br/ ><br>Timepoint: from Day 1 to Day 90