Disease Associated UnderweightMIntSNCT02383329
Effects of Oral Nutrition Supplements in Children With Disease Associated Underweight
A study testing The ONS provided to the children intervention group will be a ready to drink age adapted oral nutrition supplement providing 1,5 kcal/ml in people with Disease Associated Underweight, run by Dr. Michael Chourdakis at 19 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 24 months to 12 years
- Conditions the study is for
- Disease Associated Underweight
- What is being tested?
- The ONS provided to the children intervention group will be a ready to drink age adapted oral nutrition supplement providing 1,5 kcal/ml
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 19 sitesin 9 countries
- Study dates
- Dec 2015to May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 months to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Show all 10Show fewer
- 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
- -
Trial locations and contacts
19 sites in 9 countries.
19 sites in 9 countries
Greece4 sites
Agia Sofia Children's Hospital
Athens
Aristotle University of Thessaloniki, School of Medicine
Thessaloniki, 54124
1st Paediatric Dept, Hippokration Hospital, AUTH
Thessaloniki
3rd Paediatric Dept, Hippokration Hospital, AUTH
Thessaloniki
Turkey (Türkiye)4 sites
Hacettepe University, Ankara
Ankara, 06100
Ankara University School of Medicine
Ankara
Inönü University School of Medicine
İnönü
Dokuz Eylul University,
Izmir, Inciralti-izmir, 35340
France2 sites
Hospital Jeanne de Flandre, Pediatrics Department, CHRU
Lille
CHU Tours
Tours, 37000
Iran2 sites
Tehran University of Medical Sciences Tehrān, Children Medical Center
Tehran, 1419733151
Mofid Children Hospital
Tehran
Poland2 sites
Medical University of Warsaw
Warsaw, 01-184
The Children's Memorial Health Institute
Warsaw, 04-730
Russia2 sites
Kazan State Medical University
Kazan', Tatarstan Republic, 420012
Russian Medical Academy of Postgraduate Education
Moscow, 125480
Norway1 site
Department of Pediatrics, Women and Children's Division, Oslo University Hospital
Oslo
About this study
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
- Conditions
- Disease Associated Underweight
- Being tested
- The ONS provided to the children intervention group will be a ready to drink age adapted oral nutrition supplement providing 1,5 kcal/ml
- Keywords
- malnutrition, Underweight, Oral Nutrition Supplements, Children
- Medical subject headings
- Malnutrition, Thinness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The ONS provided to the children intervention group will be a ready to drink age adapted oral nutrition supplement providing 1,5 kcal/mlDietary 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
| Study group | Role | What they receive |
|---|---|---|
| Oral Nutritional Supplement (ONS) | Experimental | Diet consultation for the child/family + ONS Receives: 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 Oran Nutritional Supplement (ONS) | No intervention | Diet consultation for the child/family |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI z-score
The change in BMI z-score over the intervention period of 3 months
Measured: 3 months
Secondary outcomes (4)
Weight change
The change in WFH-weight for height (z-scores) over the intervention period of 3 months
Measured: 3 months
Infectious complications
Frequency of infectious complications (number of days with temperature >38,5°C, number of infections requiring antibiotic use)
Measured: 3 months
Hospital admissions
Admission for hospital inpatient treatments (number of days of hospital stay, number of admissions)
Measured: 3 months
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2015 (estimated)
- Study startDec 2015
- Primary completionMay 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disease Associated UnderweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Michael Chourdakis
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor-investigator, Dr. Michael Chourdakis, Aristotle University Of Thessaloniki
- Investigators
- Michael Chourdakis, MD PhD, Principal investigator, AUTH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02383329
- Sponsor's protocol ID
- AUTh112Med
- Acronym
- MIntS
- Status last verified
- Nov 2018
- First submitted
- 2 Mar 2015
- Last updated
- 6 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Oral Nutrition Supplements in Children With Disease Associated Underweight
- ClinicalTrials.gov ID
- NCT02383329
- Acronym / sponsor ID
- MIntS / AUTh112Med
- Conditions
- Disease Associated Underweight
- Keywords
- malnutrition, Underweight, Oral Nutrition Supplements, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Dr. Michael ChourdakisUniversity, hospital or other
- 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
- Study start
- Dec 2015 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 9 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Nutritional Supplement (ONS) | Experimental | 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/mlDiet consultation for the child/family + ONS |
| No Oran Nutritional Supplement (ONS) | No intervention | –Diet consultation for the child/family |
Who may qualify
- Ages
- 24 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The ONS provided to the children intervention group will be a ready to drink age adapted oral nutrition supplement providing 1,5 kcal/mlThe 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 | Oral Nutritional Supplement (ONS) |
Primary outcome
BMI z-score
Time frame: 3 months
The change in BMI z-score over the intervention period of 3 months
4 secondary outcomes
Weight change
Time frame: 3 months
Infectious complications
Time frame: 3 months
Hospital admissions
Time frame: 3 months
Gastrointestinal complications
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Chourdakis, MD PhD principal investigator
AUTH
19 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The ONS provided to the children intervention group will be a ready to drink age adapted oral nutrition supplement providing 1,5 kcal/ml in people with Disease Associated Underweight, run by Dr. Michael Chourdakis at 19 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Greece, Turkey (Türkiye), France, Iran, Poland and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMI z-score (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2018.