Compliance With Dietary Recommendations in Children at Risk for Undernutrition

Phase 3

Completed

• Conditions: Under-nutrition; Children

• 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

Primary Outcome Measures

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

Trial Locations

Locations (2)

Asian Hospital and Medical Center; 🇵🇭 Manilla, Philippines

The Medical City; 🇵🇭 Manilla, Philippines

Asian Hospital and Medical Center

🇵🇭Manilla, Philippines