CTRI/2014/07/004717
Completed
Phase 3
A study of an oral nutrition supplement (ONS) in children
Abbott Nutrition International India0 sites256 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Acute URTI in children
- Sponsor
- Abbott Nutrition International India
- Enrollment
- 256
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
- •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.
Outcomes
Primary Outcomes
Not specified
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