Compliance With Dietary Recommendations in Children at Risk for Undernutrition

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01658267

Enrollment

200

Registered

2012-08-07

Start date

2011-10-31

Completion date

2012-10-31

Last updated

2015-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children, Under-nutrition

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.

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.

Interventions

OTHERnutritional supplement

2 servings per day

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

36 Months to 48 Months

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

* 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.

Design outcomes

Primary

Measure	Time frame
Compliance with recommendation of a nutritional supplement consumption	48 weeks

Countries

Philippines

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026