Clinical trial NCT02419599: High vs Standard Energy Children's Drink Study
Official title: The Effect of Standard Versus High Energy Density, Low Volume Oral Nutritional Supplements in Children Requiring Nutritional Support - a Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Growth Failure
Lead sponsor: Nutricia UK Ltd
Sponsor class: INDUSTRY
First posted: 2015-04-17
Enrollment: 51
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study is a pilot trial investigating the effects of a high energy drink for children, in comparison to standard energy drink for children.

Detailed description: A four week, multi-centre, randomised controlled trial investigating the effects of a high energy density, low volume oral nutritional supplement versus standard energy density oral nutritional supplements in children aged 1-12yrs old requiring nutritional support. Fifty eligible children will be recruited and randomised to receive either the high energy density oral nutritional supplement or the standard energy density oral nutritional supplement for four weeks. The primary outcome is nutrient intake, with secondary outcomes of compliance, tolerance, acceptability, anthropometry and safety.

Eligibility criteria: Inclusion Criteria:

* Male or female
* Aged 1-12yrs
* Faltering growth and/or requiring oral nutritional supplements to meet nutritional requirements
* Expected to receive at least one bottle of the study product per day
* Able to take study products orally during the study period
* Written informed consent from parent/carer

Exclusion Criteria:

* Requirement for 100% of their nutrition via enteral tube and/or parenteral feeding.
* Children with major hepatic or renal dysfunction
* Children with galactosaemia or severe lactose intolerance
* Requirement for elemental or semi-elemental feeds
* Investigator concern around willingness/ability of child/parent/carer to comply with protocol requirements
* Participation in other studies within 2 weeks of study

Primary outcomes:
measure: Nutrient intake
timeFrame: 4 weeks (28 days)
Secondary outcomes:
measure: Compliance: Compliance with oral nutritional supplements in Group A and Group B; how much of the oral nutritional supplement is taken in comparison to the amount advised by the Dietitian.
timeFrame: 4 weeks (28 days)
measure: Tolerance: How well the child tolerates the oral nutritional supplements (including changes to gastrointestinal symptoms)
timeFrame: 4 weeks (28 days)
measure: Acceptability: How acceptable the oral nutritional supplement is to the child and their parent/carer, including taste, texture, ease of use, etc.
timeFrame: 4 weeks (28 days)
measure: Anthropometry
timeFrame: 4 weeks (28 days)
measure: Safety assessed by adverse events, to be recorded throughout study.
timeFrame: 4 weeks (28 days)
Other outcomes:
Locations:
Study officials:
References:
citation: Hubbard GP, Fry C, Sorensen K, Casewell C, Collins L, Cunjamalay A, Simpson M, Wall A, Van Wyk E, Ward M, Hallowes S, Duggan H, Robison J, Gane H, Pope L, Clark J, Stratton RJ. Energy-dense, low-volume paediatric oral nutritional supplements improve total nutrient intake and increase growth in paediatric patients requiring nutritional support: results of a randomised controlled pilot trial. Eur J Pediatr. 2020 Sep;179(9):1421-1430. doi: 10.1007/s00431-020-03620-9. Epub 2020 Mar 13.