Effects of Oral Nutrition Supplements in Children With Disease Associated Underweight

NCT02383329 | Completed

• 1 other identifier: AUTh112Med
• Study Type: interventional
• Target: 224
• Locations: 9 countries
• Sites: 19

Brief 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

Keywords

malnutrition; Underweight; Oral Nutrition Supplements; Children

Outcome Measures

Primary Outcomes (1)

• BMI z-score

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

  3 months

Secondary Outcomes (4)

• Weight change

  3 months

• Infectious complications

  3 months

• Hospital admissions

  3 months

• Gastrointestinal complications

  3 months

Study Arms (2)

Oral Nutritional Supplement (ONS)

EXPERIMENTAL

Diet consultation for the child/family + ONS

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

No Oran Nutritional Supplement (ONS)

NO INTERVENTION

Diet consultation for the child/family

Interventions

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

Oral Nutritional Supplement (ONS)

Eligibility Criteria

• Age: 24 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children treated at the participating paediatric centres during the study period (inpatients or outpatients)
• Children who would be considered candidates for oral nutrition intervention (but do not need tube feeding)
• Written informed consent of parents/caregivers

You may not qualify if:

• Children in need of intensive care
• Inability to consume ONS (e.g. major gastrointestinal dysfunction)
• Children, for whom normal nutrition intervention would be inappropriate (e.g. food intolerance, allergy)
• Use of parenteral feeding and/or enteral tube-feeding
• Severe edema (\>0.5 cm pitting edema on the dorsum of the foot)
• Participation in another intervention study involving investigational or marketed products concomitantly or within two weeks prior to entry into the trial.
• Children having received enteral nutrition treatment for underweight in the previous month
• Oncology patients during chemo-, radio-therapy

Sponsors & Collaborators

• Dr. Michael Chourdakis: lead
• Children's Hospital Zagreb: collaborator
• Universitair Ziekenhuis Brussel: collaborator
• General Hospital Of Thessaloniki Ippokratio: collaborator
• Medical University of Warsaw: collaborator
• Russian Medical Academy of Postgraduate Education: collaborator
• Oxford University Hospitals NHS Trust: collaborator
• Dokuz Eylul University: collaborator
• Ludwig-Maximilians - University of Munich: collaborator
• Aghia Sophia Children's Hospital of Athens: collaborator
• Hacettepe University: collaborator
• Children's Memorial Health Institute, Poland: collaborator
• University Hospital, Lille: collaborator
• Oslo University Hospital: collaborator
• University Hospital, Tours: collaborator

Study Sites (19)

UZ Brussel

Brussels, Belgium

Location

Children's Hospital Zagreb

Zagreb, Croatia

Location

Hospital Jeanne de Flandre, Pediatrics Department, CHRU

Lille, France

Location

CHU Tours

Tours, 37000, France

Location

Agia Sofia Children's Hospital

Athens, Greece

Location

Aristotle University of Thessaloniki, School of Medicine

Thessaloniki, 54124, Greece

Location

1st Paediatric Dept, Hippokration Hospital, AUTH

Thessaloniki, Greece

Location

3rd Paediatric Dept, Hippokration Hospital, AUTH

Thessaloniki, Greece

Location

Tehran University of Medical Sciences Tehrān, Children Medical Center

Tehran, 1419733151, Iran

Location

Mofid Children Hospital

Tehran, Iran

Location

Department of Pediatrics, Women and Children's Division, Oslo University Hospital

Oslo, Norway

Location

Medical University of Warsaw

Warsaw, 01-184, Poland

Location

The Children's Memorial Health Institute

Warsaw, 04-730, Poland

Location

Kazan State Medical University

Kazan', Tatarstan Republic, 420012, Russia

Location

Russian Medical Academy of Postgraduate Education

Moscow, 125480, Russia

Location

Dokuz Eylul University,

Izmir, Inciralti-izmir, 35340, Turkey (Türkiye)

Location

Hacettepe University, Ankara

Ankara, 06100, Turkey (Türkiye)

Location

Ankara University School of Medicine

Ankara, Turkey (Türkiye)

Location

Inönü University School of Medicine

İnönü, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Malnutrition; Thinness

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Chourdakis, MD PhD

  AUTH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer of Medical Nutrition

Study Record Dates

• First Submitted: March 2, 2015
• First Posted: March 9, 2015
• Study Start: December 1, 2015
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: November 6, 2018

Record last verified: 2018-11

Locations

CR (1); IR (2); BE (1); RU (2); TU (4); NO (1); FR (2); PL (2); GR (4)