Effects of Oral Nutrition Supplements in Children With Disease Associated Underweight

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02383329
• Date of registration: 02/03/2015
• Prospective Registration: Yes
• Primary sponsor: Dr. Michael Chourdakis
• Public title: Effects of Oral Nutrition Supplements in Children With Disease Associated Underweight MIntS
• Scientific title: Effects of Oral Nutrition Supplements in Children With Disease Associated Underweight
• Date of first enrolment: December 2015
• Target sample size: 224
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02383329
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Belgium, Croatia, France, Greece, Iran, Islamic Republic of, Norway, Poland, Russian Federation, Turkey, United Kingdom

Contacts

• Name: Michael Chourdakis, MD PhD
• Affiliation: AUTH

Key inclusion & exclusion 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

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Age minimum: 24 Months
Age maximum: 12 Years
Gender: All

Health Condition(s) or Problem(s) studied

Disease Associated Underweight

Intervention(s)

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 Outcome(s)

BMI z-score [Time Frame: 3 months]

Secondary Outcome(s)

Gastrointestinal complications [Time Frame: 3 months]

Hospital admissions [Time Frame: 3 months]

Infectious complications [Time Frame: 3 months]

Weight change [Time Frame: 3 months]

Secondary ID(s)

AUTh112Med

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Children's Hospital Zagreb

Medical University of Warsaw

Oslo University Hospital

University Hospital, Lille

Aghia Sophia Children's Hospital of Athens

Hacettepe University

Children's Memorial Health Institute, Poland

Universitair Ziekenhuis Brussel

General Hospital Of Thessaloniki Ippokratio

Oxford University Hospitals NHS Trust

Russian Medical Academy of Postgraduate Education

Dokuz Eylul University

University Hospital, Tours

Ludwig-Maximilians - University of Munich