Compliance With Dietary Recommendations in Children at Risk for Undernutrition

Abbott

Status and phase: Completed; Phase 3

Conditions: Under-nutrition; Children

Treatments: Other: nutritional supplement

Study type: Interventional

Funder types: Industry

Identifiers

NCT01658267

AK86

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 36 to 48 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Nutritional Supplement

Experimental group

Description:

Instructions and techniques to improve the quality of the diet to meet the child's daily nutritional requirements will be provided.

Treatment:

Other: nutritional supplement