Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:08 AM
Study NCT ID:
NCT02523027
Status:
COMPLETED
Last Update Posted:
2018-03-14
First Post:
2015-08-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Oral Nutritional Supplementation in Picky Eating Children
Sponsor:
Abbott Nutrition
Organization:
Study Overview
Official Title:
Oral Nutritional Supplementation in Picky Eating Children
Status:
COMPLETED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: