Growth
Conditions
Brief 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.
Interventions
OTHERNutrition supplement + dietary counseling
Nutritionally balanced nutritional supplement providing 1.0 kcal/ml.
OTHERDietary Counseling
Dietary counseling provided at each study visit by study dietitian.
Sponsors
Abbott Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
24 Months to 72 Months
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight | Study Day (SD) 1 to 90 | Change in weight-for-age from Day 1 to Day 90 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory Infections | Study Day (SD) 1 to 90 | Number and duration of recurrent acute upper respiratory tract infections per month during the study period. |
| Sick Days | 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 | 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 | Study Day (SD) 1 to 90 | Average energy consumption (values and changes from baseline). |
| Appetite Score | Study Day (SD) 3, 10, 30, 60 and 90 | Change in appetite score (values and changes from baseline) |
Countries
India
Outcome results
None listed