Compliance With Dietary Recommendations in Children at Risk for Undernutrition

Phase 3

Completed

• Conditions: Under-nutrition; Children
• Interventions: Other: nutritional supplement

• Registration Number: NCT01658267
• Lead Sponsor: Abbott 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.

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2012-07-30
• Study First Submitted QC: 2012-08-06
• Study First Posted: 2012-08-07
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-19
• Last Update Posted: 2015-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nutritional Supplement	nutritional supplement	Instructions and techniques to improve the quality of the diet to meet the child's daily nutritional requirements will be provided.

Primary Outcome Measures

Name	Time	Method
Compliance with recommendation of a nutritional supplement consumption	48 weeks

Trial Locations

Locations (2)

The Medical City; 🇵🇭 Manilla, Philippines

Asian Hospital and Medical Center; 🇵🇭 Manilla, Philippines