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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
256
Nutritionally balanced nutritional supplement providing 1.0 kcal/ml.
Dietary counseling provided at each study visit by study dietitian.
St. Theresa's Hospital
Hyderabad, Andhra Pradesh, India
Praveen Cardiac Centre
Vijayawada, Andhra Pradesh, India
Sangini Hospital
Ahmedabad, Gujarat, India
Kasturba Medical College and Hospital
Manipal, Karnataka, India
Weight
Change in weight-for-age from Day 1 to Day 90
Time frame: Study Day (SD) 1 to 90
Respiratory Infections
Number and duration of recurrent acute upper respiratory tract infections per month during the study period.
Time frame: 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.
Time frame: 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.
Time frame: Study Day (SD) 1 to 90
Dietary Intake
Average energy consumption (values and changes from baseline).
Time frame: Study Day (SD) 1 to 90
Appetite Score
Change in appetite score (values and changes from baseline)
Time frame: Study Day (SD) 3, 10, 30, 60 and 90
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Noble Hospital
Pune, Maharashtra, India
TN Medical College & BYL Nair Hospital
Mumbai, Mumbai, India
Seth GS Medical College and KEM Hospital
Mumbai-12, Mumbai, India
Institute of Child Health
Kolkata, West Bengal, India