Back to resultsCompliance With Dietary Recommendations in Children at Risk for Undernutrition
Primary Purpose
Children, Under-nutrition
Status
Completed
Phase
Phase 3
Locations
Philippines
Study Type
Interventional
Intervention
nutritional supplement
Sponsored by
About this trial
This is an interventional treatment trial for Children
Eligibility Criteria
Inclusion Criteria:
- Child is between 36 and 48 months of age.
- Child has weight-for-height greater than or equal to 5th and less than or equal to the 25th percentile.
- Child is capable of oral feeding.
- Child's parent(s)or Legal Guardian is willing to abstain from giving additional non-study nutritional supplements to the child throughout the study period.
Exclusion Criteria:
- Child whose either parent has BMI greater than or equal to 27.5 kg/m2.
- Child allergic or intolerant to any ingredient found in the study product.
- Child who was delivered pre-term.
- Child was born small for gestational
- Child had birth weight < 2500 g or > 4000 g.
- Child has current acute or chronic infections.
- Child demonstrates presence of severe gastrointestinal disorders.
- Child has a diagnosis of neoplastic diseases, renal, hepatic and cardiovascular diseases.
- Child has a diagnosis of hormonal or metabolic disorders.
- Child has a congenital disease or genetic disorder.
- Child is diagnosed with infantile anorexia nervosa.
- Child has a developmental disability or physical disorder.
- Child has disorders of hemoglobin structure, function or synthesis.
- Child is participating in another study that has not been approved as a concomitant study.
Sites / Locations
- Asian Hospital and Medical Center
- The Medical City
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Nutritional Supplement
Arm Description
Instructions and techniques to improve the quality of the diet to meet the child's daily nutritional requirements will be provided.
Outcomes
Primary Outcome Measures
Compliance with recommendation of a nutritional supplement consumption
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01658267
Brief Title
Compliance With Dietary Recommendations in Children at Risk for Undernutrition
Official Title
Compliance With Dietary Recommendations in Meeting Nutritional Requirements in Children at Risk of Undernutrition
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Nutrition
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study will assess compliance with dietary recommendations, in conjunction with a nutritional supplement to meet the nutritional requirements in children and the effects of the compliance on promoting growth in children who are at risk of under-nutrition.
Detailed Description
This study will assess compliance with dietary recommendations, in conjunction with an oral nutritional supplement to meet the nutritional requirements in children older than 36 (>36) to less than or equal 48 (≤48) months of age, and the effects of the compliance on promoting catch-up growth and normal healthy growth in children who are at risk of under-nutrition.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Children, Under-nutrition
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nutritional Supplement
Arm Type
Experimental
Arm Description
Instructions and techniques to improve the quality of the diet to meet the child's daily nutritional requirements will be provided.
Intervention Type
Other
Intervention Name(s)
nutritional supplement
Other Intervention Name(s)
Pediasure S229
Intervention Description
2 servings per day
Primary Outcome Measure Information:
Title
Compliance with recommendation of a nutritional supplement consumption
Time Frame
48 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
36 Months
Maximum Age & Unit of Time
48 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Child is between 36 and 48 months of age.
Child has weight-for-height greater than or equal to 5th and less than or equal to the 25th percentile.
Child is capable of oral feeding.
Child's parent(s)or Legal Guardian is willing to abstain from giving additional non-study nutritional supplements to the child throughout the study period.
Exclusion Criteria:
Child whose either parent has BMI greater than or equal to 27.5 kg/m2.
Child allergic or intolerant to any ingredient found in the study product.
Child who was delivered pre-term.
Child was born small for gestational
Child had birth weight < 2500 g or > 4000 g.
Child has current acute or chronic infections.
Child demonstrates presence of severe gastrointestinal disorders.
Child has a diagnosis of neoplastic diseases, renal, hepatic and cardiovascular diseases.
Child has a diagnosis of hormonal or metabolic disorders.
Child has a congenital disease or genetic disorder.
Child is diagnosed with infantile anorexia nervosa.
Child has a developmental disability or physical disorder.
Child has disorders of hemoglobin structure, function or synthesis.
Child is participating in another study that has not been approved as a concomitant study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dieu Huynh, MD, PhD
Organizational Affiliation
Abbott Nutrition, Singapore
Official's Role
Study Chair
Facility Information:
Facility Name
Asian Hospital and Medical Center
City
Manilla
Country
Philippines
Facility Name
The Medical City
City
Manilla
Country
Philippines
12. IPD Sharing Statement
Learn more about this trial
Compliance With Dietary Recommendations in Children at Risk for Undernutrition
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