Compliance With Dietary Recommendations in Children at Risk for Undernutrition

NCT01658267 | Completed Phase 3 DMC

• 1 other identifier: AK86
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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.

Conditions

Children; Under-nutrition

Outcome Measures

Primary Outcomes (1)

• Compliance with recommendation of a nutritional supplement consumption

  48 weeks

Study Arms (1)

Nutritional Supplement

EXPERIMENTAL

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

Other: nutritional supplement

Interventions

nutritional supplement OTHER

2 servings per day

Also known as: Pediasure S229

Nutritional Supplement

Eligibility Criteria

• Age: 36 Months - 48 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott Nutrition: lead

Study Sites (2)

Asian Hospital and Medical Center

Manila, Philippines

Location

The Medical City

Manila, Philippines

Location

MeSH Terms

Interventions

Dietary Supplements

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Dieu Huynh, MD, PhD

  Abbott Nutrition, Singapore

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2012
• First Posted: August 7, 2012
• Study Start: October 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: January 21, 2015

Record last verified: 2015-01

Locations

PH (2)