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Completed

NCT Number: NCT02383329

Effects of Oral Nutrition Supplements in Children With Disease Associated Underweight

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

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Key information

Conditions

Disease Associated Underweight Body Weight Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Thinness

Age range

24 month–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZ Brussel, Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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Treatment and study plan

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

Primary outcomes

  1. BMI z-score

    Time frame: 3 months

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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Dr. Michael Chourdakis

Other

Collaborators

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

Registry information

Acronym: MIntS

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Mar 9, 2015
Registry last updated
Nov 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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