Health Condition 1: null- Acute URTI in children
Conditions
Interventions
Intervention1: Oral Nutritional supplement with dietary couseling: Pediasure
For children ages 24-48 months at Visit 1, a minimum of one - 224 mL serving of supplement per day for period of 90 days.
Sponsors
Abbott Nutrition International India
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change in weight-for-age WHO z-score from Day 1 to Day 90Timepoint: from Day 1 to Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Change in weight-for-age WHO percentile 2.No. of recurrent acute URI per month during the study period. 3.No. of sick days per month assessed by the presence of any acute URTI during the study period. 4.No.of unscheduled visits per month due to development of acute URI during the study period. 5.No.of days required to recover from current episode of infection 6.Avg.energy consumption 7.Avg.energy consumption during period illness. 8.Change in appetite score Timepoint: from Day 1 to Day 90 | — |
Countries
India
Contacts
Public ContactDilip Nair
Abbott Nutrition International India
Outcome results
None listed