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CompletedNCT01658267Updated Jan 21, 2015

Compliance With Dietary Recommendations in Children at Risk for Undernutrition

A Phase 3 interventional study of nutritional supplement in Children and Under-nutrition, sponsored by Abbott Nutrition. Completed at 2 sites in Philippines. Open to participants aged 36 Months to 48 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-01-21.

Sponsored by Abbott Nutrition · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
200
Allocation
Not applicable
Ages
36 Months to 48 Months
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Children
  • Under-nutrition

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03

In context

Malnutrition

1,587 studies on the registry are indexed under Malnutrition; 237 are open to participants now.

This study's enrollment of 200 is above the median of 90 across 1,134 interventional studies indexed under Malnutrition.

Browse Malnutrition studies →

Lead sponsor

Abbott Nutrition is the lead sponsor of 153 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
36 Months to 48 Months
Sexes eligible
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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
200 participants (actual)

Study arms

  • 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

Interventions

  • Othernutritional supplement

    2 servings per day

    Also known as: Pediasure S229

06

What researchers measure

Primary outcomes

  1. Compliance with recommendation of a nutritional supplement consumption

    Time frame: 48 weeks

07

Study locations

2 sites
  • Asian Hospital and Medical Center
    Manilla, Philippines
  • The Medical City
    Manilla, Philippines
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 21, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01658267
Lead sponsor
Abbott Nutrition
Responsible party
Sponsor
First posted
Aug 7, 2012
Start date
Oct 2011
Primary completion
Oct 2012
Completion
Oct 2012
Last update
Jan 21, 2015

Study contacts

Dieu Huynh, MD, PhD
study chair · Abbott Nutrition, Singapore

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.

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