Children - Malnutrition Clinical Trial
Official title:
Oral Nutritional Supplementation in Picky Eating Children
This study will investigate the effect of two oral nutritional supplements (ONS) along with dietary counseling vs dietary counseling alone on growth among picky eating children from India, aged > 24 months to ≤ 48 months over a period of 90 days.
Study Objective:
To investigate the effect of two oral nutritional supplements (ONS) along with dietary
counseling vs dietary counseling alone on growth among picky eating children from India, aged
> 24 months to ≤ 48 months over a period of 90 days.
Number of Subjects / Length of Participation:
Approximately 321 subjects (107 subjects per group) will be enrolled from estimated 8-10
study centers to obtain at least 255 evaluable subjects (85 subjects per group), assuming 20%
attrition rate. Expected total duration for the study is approximately 12 months.
Study Design :
- Prospective, randomized, double blinded study, with two parallel treatment groups and an
open-labeled control group multicenter clinical study Eligible subjects will be
randomized into three groups
- Experimental Group 1: Oral nutritional supplement and dietary counseling. (List No
S691/Z0)
- Experimental Group 2: Oral nutritional supplement and dietary counseling. (List No-
P968/Z0)
- Control Group: Dietary counseling.
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