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Compliance With Dietary Recommendations in Children at Risk for Undernutrition

This study has been completed.
Sponsor:
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
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Abbott Nutrition:

Primary Outcome Measures:
  • Compliance with recommendation of a nutritional supplement consumption [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
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)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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

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
Health Authority: Philippines: Ethics Committee

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on September 27, 2016