Compliance With Dietary Recommendations in Children at Risk for Undernutrition
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ClinicalTrials.gov Identifier: NCT01658267 |
Recruitment Status
:
Completed
First Posted
: August 7, 2012
Last Update Posted
: January 21, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Children Under-nutrition | Other: nutritional supplement | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 200 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Compliance With Dietary Recommendations in Meeting Nutritional Requirements in Children at Risk of Undernutrition |
Study Start Date : | October 2011 |
Actual Primary Completion Date : | October 2012 |
Actual Study Completion Date : | October 2012 |
Arm | Intervention/treatment |
---|---|
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
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- Compliance with recommendation of a nutritional supplement consumption [ Time Frame: 48 weeks ]

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Ages Eligible for Study: | 36 Months to 48 Months (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01658267
Philippines | |
Asian Hospital and Medical Center | |
Manilla, Philippines | |
The Medical City | |
Manilla, Philippines |
Study Chair: | Dieu Huynh, MD, PhD | Abbott Nutrition, Singapore |
Responsible Party: | Abbott Nutrition |
ClinicalTrials.gov Identifier: | NCT01658267 History of Changes |
Other Study ID Numbers: |
AK86 |
First Posted: | August 7, 2012 Key Record Dates |
Last Update Posted: | January 21, 2015 |
Last Verified: | January 2015 |
Additional relevant MeSH terms:
Malnutrition Nutrition Disorders |