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

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ClinicalTrials.gov Identifier: NCT02383329
Recruitment Status : Completed
First Posted : March 9, 2015
Last Update Posted : November 6, 2018
Sponsor:
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
Information provided by (Responsible Party):
Dr. Michael Chourdakis, Aristotle University Of Thessaloniki

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


Condition or disease Intervention/treatment Phase
Disease Associated Underweight 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 Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 224 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effects of Oral Nutrition Supplements in Children With Disease Associated Underweight
Actual Study Start Date : December 2015
Actual Primary Completion Date : May 2018
Actual Study Completion Date : May 2018

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. BMI z-score [ Time Frame: 3 months ]
    The change in BMI z-score over the intervention period of 3 months


Secondary Outcome Measures :
  1. Weight change [ Time Frame: 3 months ]
    The change in WFH-weight for height (z-scores) over the intervention period of 3 months

  2. Infectious complications [ Time Frame: 3 months ]
    Frequency of infectious complications (number of days with temperature >38,5°C, number of infections requiring antibiotic use)

  3. Hospital admissions [ Time Frame: 3 months ]
    Admission for hospital inpatient treatments (number of days of hospital stay, number of admissions)

  4. Gastrointestinal complications [ Time Frame: 3 months ]
    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



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Ages Eligible for Study:   24 Months to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02383329


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

Responsible Party: Dr. Michael Chourdakis, Lecturer of Medical Nutrition, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier: NCT02383329     History of Changes
Other Study ID Numbers: AUTh112Med
First Posted: March 9, 2015    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018

Keywords provided by Dr. Michael Chourdakis, Aristotle University Of Thessaloniki:
malnutrition
Underweight
Oral Nutrition Supplements
Children

Additional relevant MeSH terms:
Thinness
Body Weight
Signs and Symptoms