Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-25 @ 5:05 AM
NCT ID:
NCT02523027
Brief Summary:
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.
Detailed Description:
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.
Study:
NCT02523027
Study Brief:
Protocol Section:
NCT02523027