CTRI/2015/10/006330
Completed
Phase 4
A study of an oral nutritional supplementation in picky eating children
Abbott Nutrition International India0 sites321 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Abbott Nutrition International India
- Enrollment
- 321
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\)Child is \> 24 months and \<\= 48 months of age at visit 1\.
- •2\)Child of either gender (Male and Female).
- •3\)Child has a weight\-for\-height between 3rd â?? 15th percentiles according to current WHO Growth Charts at visit 1\. (WHO Growth Chart 2007\)
- •4\)Child is a picky eater, defined as meeting at least two of the following criteria. A child, who
- •a.eats only a limited number of foods
- •b.is unwilling to try new foods
- •c.refuses to eat vegetables and/or foods from other food groups
- •d.shows strong food likes and dislikes
- •e.has behaviors that disrupt mealtime
- •5\)Child is a habitual milk drinker at least 1 glass (approx. 200ml) of milk daily.
Exclusion Criteria
- •1\)Child has been diagnosed with Lactose Intolerance \& Galactosemia according to medical records or LG/parent report.
- •2\)Child has been diagnosed or is known to be allergic or intolerant to any ingredient found in the study product according to medical records or LG/parent report.
- •3\)Child has a current acute or chronic infection including but not restricted to respiratory infection, diarrhea, Hepatitis B or C, HIV infection or tuberculosis according to medical records or LG/parent report based on the clinicianâ??s judgment.
- •4\)Child has been diagnosed with presence of severe gastrointestinal disorders including celiac disease, short bowel syndrome, pancreatic insufficiency, or cystic fibrosis according to medical records or LG/parent report.
- •5\)Child has been diagnosed with neoplastic, renal, hepatic or cardiovascular disease according to medical records or LG/parent report.
- •6\)Child has been diagnosed with hormonal or metabolic disorders according to medical records or LG/parent report.
- •7\)Child has been diagnosed with congenital disease or genetic disorders such as atrial or ventricular wall defects, or Downâ??s syndrome according to medical records or LG/parent report.
- •8\)Child has been diagnosed with infantile anorexia nervosa according to medical records or LG/parent report.
- •9\)Child has been diagnosed with a developmental disability, including physical disorders such as cerebral palsy, or developmental delay according to medical records or LG/parent report.
- •10\)Child has been diagnosed with disorders of hemoglobin structure, function or synthesis according to medical records or LG/parent report.
Outcomes
Primary Outcomes
Not specified
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