Effects of Oral Nutrition Supplements in Children With Disease Associated Underweight

Summary

The purpose of this study is to test whether the provision of ONS to malnourished children across Europe, in addition to standard counselling, will improve weight gain and other outcomes.

The hypothesis to be tested is:

• Supplementation with ONS in malnourished paediatric patients will lead to increased WFH gain, as well as less malnutrition related complications (e.g. infections).

Primary outcome • The change in BMI z-score over the intervention period of 3 months

Secondary outcomes

• The change in WFH-weight for height (z-scores) over the intervention period of 3 months

Conditions

• Disease Associated Underweight

Interventions

DIETARY_SUPPLEMENT

The ONS provided to the children intervention group will be a ready to drink age adapted oral nutrition supplement providing 1,5 kcal/ml

The ONS provided to the children intervention group will be a ready to drink age adapted oral nutrition supplement providing 1,5 kcal/ml

Sponsors & Collaborators

• Children's Hospital Zagreb

  collaborator OTHER

• Universitair Ziekenhuis Brussel

  collaborator OTHER

• General Hospital Of Thessaloniki Ippokratio

  collaborator OTHER

• Medical University of Warsaw

  collaborator OTHER

• Russian Medical Academy of Postgraduate Education

  collaborator OTHER

• Oxford University Hospitals NHS Trust

  collaborator OTHER

• Dokuz Eylul University

  collaborator OTHER

• Ludwig-Maximilians - University of Munich

  collaborator OTHER

• Aghia Sophia Children's Hospital of Athens

  collaborator OTHER

• Hacettepe University

  collaborator OTHER

• Children's Memorial Health Institute, Poland

  collaborator OTHER

• University Hospital, Lille

  collaborator OTHER

• Oslo University Hospital

  collaborator OTHER

• University Hospital, Tours

  collaborator OTHER

• Dr. Michael Chourdakis

  lead OTHER

Principal Investigators

• Michael Chourdakis, MD PhD · AUTH

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

24 Months

Max Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-12-31

Primary Completion

2018-05-31

Completion

2018-05-31

Countries

• Belgium
• Croatia
• France
• Greece
• Iran
• Norway
• Poland
• Russia
• Turkey (Türkiye)

Study Locations