Effects of Oral Nutrition Supplements in Children With Disease Associated Underweight (MIntS)

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

Study Overview

• Status: Completed
• Conditions: Disease Associated Underweight
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 224
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussel, Belgium
    • UZ Brussel
• Croatia
  • Zagreb, Croatia
    • Children's Hospital Zagreb
• France
  • Lille, France
    • Hospital Jeanne de Flandre, Pediatrics Department, CHRU
  • Tours, France, 37000
    • CHU Tours
• Greece
  • Athens, Greece
    • Agia Sofia Children's Hospital
  • Thessaloniki, Greece, 54124
    • Aristotle University Of Thessaloniki, School of Medicine
  • Thessaloniki, Greece
    • 1st Paediatric Dept, Hippokration Hospital, AUTH
  • Thessaloniki, Greece
    • 3rd Paediatric Dept, Hippokration Hospital, AUTH
• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of, 1419733151
    • Tehran University of Medical Sciences Tehrān, Children Medical Center
  • Tehran, Iran, Islamic Republic of
    • Mofid Children Hospital
• Norway
  • Oslo, Norway
    • Department of Pediatrics, Women and Children's Division, Oslo University Hospital
• Poland
  • Warszawa, Poland, 01-184
    • Medical University of Warsaw
  • Warszawa, Poland, 04-730
    • The Children's Memorial Health Institute
• Russian Federation
  • Moscow, Russian Federation, 125480
    • Russian Medical Academy of Postgraduate Education
  • Respublika Tatarstan
    • Kazan, Respublika Tatarstan, Russian Federation, 420012
      • Kazan State Medical University
• Turkey
  • Ankara, Turkey
    • Ankara University School of Medicine
  • Ankara, Turkey, 06100
    • Hacettepe University, Ankara
  • Inönü, Turkey
    • Inönü University School of Medicine
  • Inciralti-izmir
    • Izmir, Inciralti-izmir, Turkey, 35340
      • Dokuz Eylul University,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Children treated at the participating paediatric centres during the study period (inpatients or outpatients)
2. Age between 24 months to 12 years at inclusion
3. WFH at inclusion <- 1,5 SD - >-2,5 SD (based on WHO) OR Decrease in WFH z-score of ≥1 SD within the last 3 months, and underlying disease with high risk of undernutrition
4. Children who would be considered candidates for oral nutrition intervention (but do not need tube feeding)
5. Written informed consent of parents/caregivers

Exclusion Criteria:

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

9. Expected hospital stay at inclusion longer than 7 days

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral Nutritional Supplement (ONS); 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; 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 Intervention: No Oran Nutritional Supplement (ONS); Diet consultation for the child/family

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BMI z-score	The change in BMI z-score over the intervention period of 3 months	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight change	The change in WFH-weight for height (z-scores) over the intervention period of 3 months	3 months
Infectious complications	Frequency of infectious complications (number of days with temperature >38,5°C, number of infections requiring antibiotic use)	3 months
Hospital admissions	Admission for hospital inpatient treatments (number of days of hospital stay, number of admissions)	3 months
Gastrointestinal complications	Frequency of gastrointestinal complications (number of days with diarrhoea/vomiting as reported by carers). Other GI symptoms could be recorded, as potential reason for lower food intake	3 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2015
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: March 2, 2015
• First Submitted That Met QC Criteria: March 4, 2015
• First Posted (Estimate): March 9, 2015

Study Record Updates

• Last Update Posted (Actual): November 6, 2018
• Last Update Submitted That Met QC Criteria: November 5, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Children; malnutrition; Underweight; Oral Nutrition Supplements
• Additional Relevant MeSH Terms: Body Weight; Thinness
• Other Study ID Numbers: AUTh112Med