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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
321
(List No S691/Z0)
(List No- P968/Z0)
Regular dietary counseling conducted by a trained hospital dietitian.
Praveen Cardiac Centre
Vijayawada, Andhra Pradesh, India
St. Theresa's Hospital
Hyderabad, Erragadda, Sanath Nagar, India
Sangini Hospital
Ahmedabad, Gujarat, India
Change in WHO weight-for-height percentile
Time frame: Day 1 to Day 90
Change in weight-for-height WHO z-score
Time frame: Day 1 to Day 90
Change in weight-for-age WHO z-score and percentile
Time frame: Day 1 to Day 90
Change in height-for-age WHO z-score and percentile
Time frame: Day 1 to Day 90
Change in BMI-for-age WHO z-score and percentile
Time frame: Day 1 to Day 90
Change in Mid Upper Arm Circumference-for-age WHO z-score and percentile
Time frame: Day 1 to Day 90
Average energy macronutrients (Carbohydrates, Fats, & Proteins) and micronutrients consumption via 24 hr dietary recall
Time frame: Days 1, 7, 30, 60 and 90
Change in appetite score
Time frame: Days 1, 7, 30, 60 and 90
Palatability scores for the oral nutritional supplements
Time frame: Days 7, 30, 60 and 90
Change in weight-for-height WHO z-score and percentile
Time frame: Day 1 to Day 90
Average energy macronutrients (Carbohydrates, Fats, & Proteins) and micronutrients consumption via 24 hr dietary recall
Time frame: Day 1, 7, 30, 60 and 90
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
JSS Medical College & Hospital
Mysore, Karnataka, India
Jehangir Clinical Development Centre, Jehangir Hospital
Pune, Maharashtra, India
Medipoint Hospitals
Pune, Maharashtra, India
Noble Hospital
Pune, Maharashtra, India
Sterling Multispeciality Hospital
Pune, Maharashtra, India
Kanchi Kamakoti Child Trust Hospital
Chennai, Tamil Nadu, India
Ajanta Research Centre, Ajanta Hospital & IVF Centre
Lucknow, Uttar Pradesh, India
...and 1 more locations