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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

Tracking Information
First Submitted Date  ICMJE March 2, 2015
First Posted Date  ICMJE March 9, 2015
Last Update Posted Date November 6, 2018
Actual Study Start Date  ICMJE December 2015
Actual Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 5, 2018)
BMI z-score [ Time Frame: 3 months ]
The change in BMI z-score over the intervention period of 3 months
Original Primary Outcome Measures  ICMJE
 (submitted: March 4, 2015)
weight change [ Time Frame: 3 months ]
The change in WFH-weight for height (z-scores) over the intervention period of 3 months
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 5, 2018)
  • Weight change [ Time Frame: 3 months ]
    The change in WFH-weight for height (z-scores) over the intervention period of 3 months
  • Infectious complications [ Time Frame: 3 months ]
    Frequency of infectious complications (number of days with temperature >38,5°C, number of infections requiring antibiotic use)
  • Hospital admissions [ Time Frame: 3 months ]
    Admission for hospital inpatient treatments (number of days of hospital stay, number of admissions)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: March 4, 2015)
BMI z-score [ Time Frame: 3 months ]
The change in BMI z-score over the intervention period of 3 months
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Oral Nutrition Supplements in Children With Disease Associated Underweight
Official Title  ICMJE Effects of Oral Nutrition Supplements in Children With Disease Associated Underweight
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

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Disease Associated Underweight
Intervention  ICMJE 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
Study Arms  ICMJE
  • Experimental: Oral Nutritional Supplement (ONS)
    Diet consultation for the child/family + ONS
    Intervention: 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 Intervention: No Oran Nutritional Supplement (ONS)
    Diet consultation for the child/family
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 30, 2018)
224
Original Estimated Enrollment  ICMJE
 (submitted: March 4, 2015)
213
Actual Study Completion Date  ICMJE May 2018
Actual Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

    -

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 24 Months to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Croatia,   France,   Greece,   Iran, Islamic Republic of,   Norway,   Poland,   Russian Federation,   Turkey
Removed Location Countries United Kingdom
 
Administrative Information
NCT Number  ICMJE NCT02383329
Other Study ID Numbers  ICMJE AUTh112Med
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Michael Chourdakis, Aristotle University Of Thessaloniki
Study Sponsor  ICMJE Dr. Michael Chourdakis
Collaborators  ICMJE
  • 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  ICMJE
Principal Investigator: Michael Chourdakis, MD PhD AUTH
PRS Account Aristotle University Of Thessaloniki
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP