Disease Associated Underweight Clinical Trial
— MIntSOfficial title:
Effects of Oral Nutrition Supplements in Children With Disease Associated Underweight
| NCT number | NCT02383329 |
| Other study ID # | AUTh112Med |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | December 2015 |
| Est. completion date | May 2018 |
| Verified date | November 2018 |
| Source | Aristotle University Of Thessaloniki |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 224 |
| Est. completion date | May 2018 |
| Est. primary completion date | May 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 24 Months to 12 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | UZ Brussel | Brussel | |
| Croatia | Children's Hospital Zagreb | Zagreb | |
| France | Hospital Jeanne de Flandre, Pediatrics Department, CHRU | Lille | |
| France | CHU Tours | Tours | |
| Greece | Agia Sofia Children's Hospital | Athens | |
| Greece | 1st Paediatric Dept, Hippokration Hospital, AUTH | Thessaloniki | |
| Greece | 3rd Paediatric Dept, Hippokration Hospital, AUTH | Thessaloniki | |
| Greece | Aristotle University of Thessaloniki, School of Medicine | Thessaloniki | |
| Iran, Islamic Republic of | Mofid Children Hospital | Tehran | |
| Iran, Islamic Republic of | Tehran University of Medical Sciences Tehran, Children Medical Center | Tehran | |
| Norway | Department of Pediatrics, Women and Children's Division, Oslo University Hospital | Oslo | |
| Poland | Medical University of Warsaw | Warszawa | |
| Poland | The Children's Memorial Health Institute | Warszawa | |
| Russian Federation | Kazan State Medical University | Kazan | Respublika Tatarstan |
| Russian Federation | Russian Medical Academy of Postgraduate Education | Moscow | |
| Turkey | Ankara University School of Medicine | Ankara | |
| Turkey | Hacettepe University, Ankara | Ankara | |
| Turkey | Inönü University School of Medicine | Inönü | |
| Turkey | Dokuz Eylul University, | Izmir | Inciralti-izmir |
| Lead Sponsor | Collaborator |
|---|---|
| Dr. Michael Chourdakis | 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 |
Belgium, Croatia, France, Greece, Iran, Islamic Republic of, Norway, Poland, Russian Federation, Turkey,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | BMI z-score | The change in BMI z-score over the intervention period of 3 months | 3 months | |
| Secondary | Weight change | The change in WFH-weight for height (z-scores) over the intervention period of 3 months | 3 months | |
| Secondary | Infectious complications | Frequency of infectious complications (number of days with temperature >38,5°C, number of infections requiring antibiotic use) | 3 months | |
| Secondary | Hospital admissions | Admission for hospital inpatient treatments (number of days of hospital stay, number of admissions) | 3 months | |
| Secondary | 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 | 3 months |