NCT02523027

Oral Nutritional Supplementation in Picky Eating Children

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 321 (actual)
• Sponsor: Abbott Nutrition · Industry
• Sex: All
• Age: 2 Years – 4 Years
• Healthy volunteers: Accepted

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.

Conditions

• Children - Malnutrition

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Oral nutritional supplement (List No S691/Z0)	(List No S691/Z0)
DIETARY_SUPPLEMENT	Oral nutritional supplement	(List No- P968/Z0)
OTHER	Dietary Counselling	Regular dietary counseling conducted by a trained hospital dietitian.

Timeline

• Start date: 2016-06-21
• Primary completion: 2017-02-17
• Completion: 2017-08-01
• First posted: 2015-08-14
• Last updated: 2018-03-14

Locations

11 sites across 1 country: India