A Phase 2/3 interventional study of Oral nutritional supplement (List No S691/Z0) and Oral nutritional supplement in Children - Malnutrition, sponsored by Abbott Nutrition. Completed at 11 sites in India. Open to participants aged 2 Years to 4 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-14.
Sponsored by Abbott Nutrition · Phase 2/3, Interventional, and Supportive care
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 :
1,587 studies on the registry are indexed under Malnutrition; 237 are open to participants now.
This study's enrollment of 321 is above the median of 90 across 1,134 interventional studies indexed under Malnutrition.
Browse Malnutrition studies →Abbott Nutrition is the lead sponsor of 153 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Child is a picky eater, defined as meeting at least two of the following criteria. A child, who:
Exclusion Criteria:
Oral nutritional supplement (List No S691/Z0) and dietary counseling
Dietary Supplement: Oral nutritional supplement (List No S691/Z0) · Other: Dietary Counselling
Oral nutritional supplement (List No- P968/Z0) and dietary counseling.
Dietary Supplement: Oral nutritional supplement · Other: Dietary Counselling
Dietary Counselling only.
(List No S691/Z0)
(List No- P968/Z0)
Regular dietary counseling conducted by a trained hospital dietitian.
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
Plan to share: No
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This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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