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Completed

NCT Number: NCT01658267

Compliance With Dietary Recommendations in Children at Risk for Undernutrition

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.

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Key information

Age range

36 month–48 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Asian Hospital and Medical Center, Manila, Philippines

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nutritional Supplement

Other

2 servings per day

Other names: Pediasure S229

Primary outcomes

  1. Compliance with recommendation of a nutritional supplement consumption

    Time frame: 48 weeks

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Official study title

Compliance With Dietary Recommendations in Meeting Nutritional Requirements in Children at Risk of Undernutrition

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Aug 7, 2012
Registry last updated
Jan 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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