Compliance With Dietary Recommendations in Children at Risk for Undernutrition

Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01658267
• Other study ID #: AK86
• Status: Completed
• Phase: Phase 3
• First received: July 30, 2012
• Last updated: January 19, 2015
• Start date: October 2011
• Est. completion date: October 2012

Study information

• Verified date: January 2015
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Health authority: Philippines: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 36 Months to 48 Months

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Children
• Malnutrition
• Under-nutrition

Intervention

Other:
• nutritional supplement
2 servings per day

Locations

Country	Name	City	State
Philippines	Asian Hospital and Medical Center	Manilla
Philippines	The Medical City	Manilla

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compliance with recommendation of a nutritional supplement consumption		48 weeks	No