ClinicalTrials.gov
ClinicalTrials.gov Menu

Compliance With Dietary Recommendations in Children at Risk for Undernutrition

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01658267
Recruitment Status : Completed
First Posted : August 7, 2012
Last Update Posted : January 21, 2015
Sponsor:
Information provided by (Responsible Party):
Abbott Nutrition

Study Description
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Children Under-nutrition Other: nutritional supplement Phase 3

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.

Study Design
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Compliance with recommendation of a nutritional supplement consumption [ Time Frame: 48 weeks ]

Eligibility Criteria
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


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
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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