Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
51 participants
INTERVENTIONAL
2015-08-31
2016-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Group A
The group who will receive high energy density, low volume oral nutritional supplement, to be taken for 4 weeks (28 days)
HE ONS
High energy density, low volume oral nutritional supplement (HE ONS) in addition to appropriate nutritional management
Group B
The group who will receive the standard energy density oral nutritional supplement, to be taken for 4 weeks (28 days)
SE ONS
Standard energy density oral nutritional supplement (SE ONS) in addition to appropriate nutritional management
Interventions
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HE ONS
High energy density, low volume oral nutritional supplement (HE ONS) in addition to appropriate nutritional management
SE ONS
Standard energy density oral nutritional supplement (SE ONS) in addition to appropriate nutritional management
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
1 Year
12 Years
ALL
No
Sponsors
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Nutricia UK Ltd
INDUSTRY
Responsible Party
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References
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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.
Other Identifiers
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FC125
Identifier Type: -
Identifier Source: org_study_id