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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ONS + dietary counseling | Experimental | ONS/day + dietary counseling |
|
| Dietary counseling | Active Comparator | Dietary counseling |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutrition supplement + dietary counseling | Other | Nutritionally balanced nutritional supplement providing 1.0 kcal/ml. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Weight | Change in weight-for-age from Day 1 to Day 90 | Study Day (SD) 1 to 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory Infections | Number and duration of recurrent acute upper respiratory tract infections per month during the study period. | Study Day (SD) 1 to 90 |
| Sick Days | Number of sick days per month assessed by the presence of any acute upper respiratory tract infections during the study period. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vinita Satyavrat, MD | Abbott Nutrition | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Theresa's Hospital | Hyderabad | Andhra Pradesh | 500018 | India | ||
| Praveen Cardiac Centre |
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| ID | Term |
|---|---|
| D015596 | Nutrition Assessment |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| Dietary Counseling | Other | Dietary counseling provided at each study visit by study dietitian. |
|
| Study Day (SD) 1 to 90 |
| Doctor Visits | Number of unscheduled visits per month due to development of acute upper respiratory tract infections during the study period. | Study Day (SD) 1 to 90 |
| Dietary Intake | Average energy consumption (values and changes from baseline). | Study Day (SD) 1 to 90 |
| Appetite Score | Change in appetite score (values and changes from baseline) | Study Day (SD) 3, 10, 30, 60 and 90 |
| Vijayawada |
| Andhra Pradesh |
| 520002 |
| India |
| Sangini Hospital | Ahmedabad | Gujarat | 380006 | India |
| Kasturba Medical College and Hospital | Manipal | Karnataka | 567104 | India |
| Noble Hospital | Pune | Maharashtra | 411013 | India |
| TN Medical College & BYL Nair Hospital | Mumbai | Mumbai | 400 008 | India |
| Seth GS Medical College and KEM Hospital | Mumbai-12 | Mumbai | India |
| Institute of Child Health | Kolkata | West Bengal | 700 017 | India |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |