High vs Standard Energy Children's Drink Study
Status
Conditions
Treatments
Details and patient eligibility
About
This study is a pilot trial investigating the effects of a high energy drink for children, in comparison to standard energy drink for children.
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
51 participants in 2 patient groups
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal