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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: May 8, 2013
Last verified: May 2013
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: diet counseling and 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

  Eligibility

Ages Eligible for Study:   36 Months to 48 Months
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
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

No publications provided

Responsible Party: Abbott Nutrition
ClinicalTrials.gov Identifier: NCT01658267     History of Changes
Other Study ID Numbers: AK86
Study First Received: July 30, 2012
Last Updated: May 8, 2013
Health Authority: Philippines: Institutional Review Board

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on May 16, 2013