Effects of Oral Nutrition Supplements in Children With Disease Associated Underweight (MIntS)

Dr. Michael Chourdakis

Status: Completed

Conditions: Disease Associated Underweight

Treatments: 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

Study type: Interventional

Funder types: Other

Identifiers

NCT02383329

AUTh112Med

Details and patient eligibility

About

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

Enrollment: 224 patients

Sex: All

Ages: 24 months to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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224 participants in 2 patient groups

Oral Nutritional Supplement (ONS)

Experimental group

Description:

Diet consultation for the child/family + ONS

Treatment:

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 group

Description:

Diet consultation for the child/family