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

Primary Purpose

Disease Associated Underweight

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
The ONS provided to the children intervention group will be a ready to drink age adapted oral nutrition supplement providing 1,5 kcal/ml
Sponsored by
Dr. Michael Chourdakis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Disease Associated Underweight focused on measuring malnutrition, Underweight, Oral Nutrition Supplements, Children

Eligibility Criteria

24 Months - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

    -

Sites / Locations

  • UZ Brussel
  • Children's Hospital Zagreb
  • Hospital Jeanne de Flandre, Pediatrics Department, CHRU
  • CHU Tours
  • Agia Sofia Children's Hospital
  • Aristotle University of Thessaloniki, School of Medicine
  • 1st Paediatric Dept, Hippokration Hospital, AUTH
  • 3rd Paediatric Dept, Hippokration Hospital, AUTH
  • Tehran University of Medical Sciences Tehrān, Children Medical Center
  • Mofid Children Hospital
  • Department of Pediatrics, Women and Children's Division, Oslo University Hospital
  • Medical University of Warsaw
  • The Children's Memorial Health Institute
  • Kazan State Medical University
  • Russian Medical Academy of Postgraduate Education
  • Dokuz Eylul University,
  • Hacettepe University, Ankara
  • Ankara University School of Medicine
  • Inönü University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Oral Nutritional Supplement (ONS)

No Oran Nutritional Supplement (ONS)

Arm Description

Diet consultation for the child/family + ONS

Diet consultation for the child/family

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Weight change
The change in WFH-weight for height (z-scores) over the intervention period of 3 months
Infectious complications
Frequency of infectious complications (number of days with temperature >38,5°C, number of infections requiring antibiotic use)
Hospital admissions
Admission for hospital inpatient treatments (number of days of hospital stay, number of admissions)
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

Full Information

First Posted
March 2, 2015
Last Updated
November 5, 2018
Sponsor
Dr. Michael Chourdakis
Collaborators
Children's Hospital Zagreb, Universitair Ziekenhuis Brussel, General Hospital Of Thessaloniki Ippokratio, Medical University of Warsaw, Russian Medical Academy of Postgraduate Education, Oxford University Hospitals NHS Trust, Dokuz Eylul University, Ludwig-Maximilians - University of Munich, Aghia Sophia Children's Hospital of Athens, Hacettepe University, Children's Memorial Health Institute, Poland, University Hospital, Lille, Oslo University Hospital, University Hospital, Tours
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1. Study Identification

Unique Protocol Identification Number
NCT02383329
Brief Title
Effects of Oral Nutrition Supplements in Children With Disease Associated Underweight
Acronym
MIntS
Official Title
Effects of Oral Nutrition Supplements in Children With Disease Associated Underweight
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
December 2015 (Actual)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
May 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Michael Chourdakis
Collaborators
Children's Hospital Zagreb, Universitair Ziekenhuis Brussel, General Hospital Of Thessaloniki Ippokratio, Medical University of Warsaw, Russian Medical Academy of Postgraduate Education, Oxford University Hospitals NHS Trust, Dokuz Eylul University, Ludwig-Maximilians - University of Munich, Aghia Sophia Children's Hospital of Athens, Hacettepe University, Children's Memorial Health Institute, Poland, University Hospital, Lille, Oslo University Hospital, University Hospital, Tours

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disease Associated Underweight
Keywords
malnutrition, Underweight, Oral Nutrition Supplements, Children

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
224 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oral Nutritional Supplement (ONS)
Arm Type
Experimental
Arm Description
Diet consultation for the child/family + ONS
Arm Title
No Oran Nutritional Supplement (ONS)
Arm Type
No Intervention
Arm Description
Diet consultation for the child/family
Intervention Type
Dietary Supplement
Intervention Name(s)
The ONS provided to the children intervention group will be a ready to drink age adapted oral nutrition supplement providing 1,5 kcal/ml
Intervention Description
The ONS provided to the children intervention group will be a ready to drink age adapted oral nutrition supplement providing 1,5 kcal/ml
Primary Outcome Measure Information:
Title
BMI z-score
Description
The change in BMI z-score over the intervention period of 3 months
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Weight change
Description
The change in WFH-weight for height (z-scores) over the intervention period of 3 months
Time Frame
3 months
Title
Infectious complications
Description
Frequency of infectious complications (number of days with temperature >38,5°C, number of infections requiring antibiotic use)
Time Frame
3 months
Title
Hospital admissions
Description
Admission for hospital inpatient treatments (number of days of hospital stay, number of admissions)
Time Frame
3 months
Title
Gastrointestinal complications
Description
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
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
24 Months
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children treated at the participating paediatric centres during the study period (inpatients or outpatients) Age between 24 months to 12 years at inclusion 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 Children who would be considered candidates for oral nutrition intervention (but do not need tube feeding) Written informed consent of parents/caregivers Exclusion Criteria: 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 Expected hospital stay at inclusion longer than 7 days -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Chourdakis, MD PhD
Organizational Affiliation
AUTH
Official's Role
Principal Investigator
Facility Information:
Facility Name
UZ Brussel
City
Brussel
Country
Belgium
Facility Name
Children's Hospital Zagreb
City
Zagreb
Country
Croatia
Facility Name
Hospital Jeanne de Flandre, Pediatrics Department, CHRU
City
Lille
Country
France
Facility Name
CHU Tours
City
Tours
ZIP/Postal Code
37000
Country
France
Facility Name
Agia Sofia Children's Hospital
City
Athens
Country
Greece
Facility Name
Aristotle University of Thessaloniki, School of Medicine
City
Thessaloniki
ZIP/Postal Code
54124
Country
Greece
Facility Name
1st Paediatric Dept, Hippokration Hospital, AUTH
City
Thessaloniki
Country
Greece
Facility Name
3rd Paediatric Dept, Hippokration Hospital, AUTH
City
Thessaloniki
Country
Greece
Facility Name
Tehran University of Medical Sciences Tehrān, Children Medical Center
City
Tehran
ZIP/Postal Code
1419733151
Country
Iran, Islamic Republic of
Facility Name
Mofid Children Hospital
City
Tehran
Country
Iran, Islamic Republic of
Facility Name
Department of Pediatrics, Women and Children's Division, Oslo University Hospital
City
Oslo
Country
Norway
Facility Name
Medical University of Warsaw
City
Warszawa
ZIP/Postal Code
01-184
Country
Poland
Facility Name
The Children's Memorial Health Institute
City
Warszawa
ZIP/Postal Code
04-730
Country
Poland
Facility Name
Kazan State Medical University
City
Kazan
State/Province
Respublika Tatarstan
ZIP/Postal Code
420012
Country
Russian Federation
Facility Name
Russian Medical Academy of Postgraduate Education
City
Moscow
ZIP/Postal Code
125480
Country
Russian Federation
Facility Name
Dokuz Eylul University,
City
Izmir
State/Province
Inciralti-izmir
ZIP/Postal Code
35340
Country
Turkey
Facility Name
Hacettepe University, Ankara
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Ankara University School of Medicine
City
Ankara
Country
Turkey
Facility Name
Inönü University School of Medicine
City
Inönü
Country
Turkey

12. IPD Sharing Statement

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Effects of Oral Nutrition Supplements in Children With Disease Associated Underweight

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