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Compliance With Dietary Recommendations in Children at Risk for Undernutrition
This study has been completed.
Sponsor:
Abbott Nutrition
Information provided by (Responsible Party):
Abbott Nutrition
ClinicalTrials.gov Identifier:
NCT01658267
First received: July 30, 2012
Last updated: January 19, 2015
Last verified: January 2015
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Children Under-nutrition | Other: nutritional supplement | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Compliance With Dietary Recommendations in Meeting Nutritional Requirements in Children at Risk of Undernutrition |
Resource links provided by NLM:
Further study details as provided by Abbott Nutrition:
Primary Outcome Measures:
- Compliance with recommendation of a nutritional supplement consumption [ Time Frame: 48 weeks ]
| Enrollment: | 200 |
| Study Start Date: | October 2011 |
| Study Completion Date: | October 2012 |
| Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Nutritional Supplement
Instructions and techniques to improve the quality of the diet to meet the child's daily nutritional requirements will be provided.
|
Other: nutritional supplement
2 servings per day
Other Name: Pediasure S229
|
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.
Eligibility| Ages Eligible for Study: | 36 Months to 48 Months (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01658267
Please refer to this study by its ClinicalTrials.gov identifier: NCT01658267
Locations
| Philippines | |
| Asian Hospital and Medical Center | |
| Manilla, Philippines | |
| The Medical City | |
| Manilla, Philippines | |
Sponsors and Collaborators
Abbott Nutrition
Investigators
| Study Chair: | Dieu Huynh, MD, PhD | Abbott Nutrition, Singapore |
More Information
| Responsible Party: | Abbott Nutrition |
| ClinicalTrials.gov Identifier: | NCT01658267 History of Changes |
| Other Study ID Numbers: |
AK86 |
| Study First Received: | July 30, 2012 |
| Last Updated: | January 19, 2015 |
Additional relevant MeSH terms:
|
Malnutrition Nutrition Disorders |
ClinicalTrials.gov processed this record on July 21, 2017