Back to resultsHigh vs Standard Energy Children's Drink Study
Primary Purpose
Growth Failure
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
HE ONS
SE ONS
Sponsored by
About this trial
This is an interventional other trial for Growth Failure
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group A
Group B
Arm Description
The group who will receive high energy density, low volume oral nutritional supplement, to be taken for 4 weeks (28 days)
The group who will receive the standard energy density oral nutritional supplement, to be taken for 4 weeks (28 days)
Outcomes
Primary Outcome Measures
Nutrient intake
Dietary intake, including the intake of all foods and fluids, will be recorded and analysed throughout the study.
Secondary Outcome Measures
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.
Tolerance: How well the child tolerates the oral nutritional supplements (including changes to gastrointestinal symptoms)
Acceptability: How acceptable the oral nutritional supplement is to the child and their parent/carer, including taste, texture, ease of use, etc.
Anthropometry
Changes to weight, height and head circumference in children less than 2yrs of age.
Safety assessed by adverse events, to be recorded throughout study.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02419599
Brief Title
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
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nutricia UK Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Growth Failure
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
The group who will receive high energy density, low volume oral nutritional supplement, to be taken for 4 weeks (28 days)
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
The group who will receive the standard energy density oral nutritional supplement, to be taken for 4 weeks (28 days)
Intervention Type
Other
Intervention Name(s)
HE ONS
Intervention Description
High energy density, low volume oral nutritional supplement (HE ONS) in addition to appropriate nutritional management
Intervention Type
Other
Intervention Name(s)
SE ONS
Intervention Description
Standard energy density oral nutritional supplement (SE ONS) in addition to appropriate nutritional management
Primary Outcome Measure Information:
Title
Nutrient intake
Description
Dietary intake, including the intake of all foods and fluids, will be recorded and analysed throughout the study.
Time Frame
4 weeks (28 days)
Secondary Outcome Measure Information:
Title
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.
Time Frame
4 weeks (28 days)
Title
Tolerance: How well the child tolerates the oral nutritional supplements (including changes to gastrointestinal symptoms)
Time Frame
4 weeks (28 days)
Title
Acceptability: How acceptable the oral nutritional supplement is to the child and their parent/carer, including taste, texture, ease of use, etc.
Time Frame
4 weeks (28 days)
Title
Anthropometry
Description
Changes to weight, height and head circumference in children less than 2yrs of age.
Time Frame
4 weeks (28 days)
Title
Safety assessed by adverse events, to be recorded throughout study.
Time Frame
4 weeks (28 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32170451
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.
Results Reference
derived
Learn more about this trial
High vs Standard Energy Children's Drink Study
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