High vs Standard Energy Children's Drink Study

Growth Failure Clinical Trial

Official title:

The Effect of Standard Versus High Energy Density, Low Volume Oral Nutritional Supplements in Children Requiring Nutritional Support - a Pilot Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02419599
• Other study ID #: FC125
• Status: Completed
• Phase: N/A
• First received: April 14, 2015
• Last updated: October 30, 2017
• Start date: August 2015
• Est. completion date: August 2016

Study information

• Verified date: October 2017
• Source: Nutricia UK Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Failure to Thrive
• Growth Failure

Intervention

Other:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nutricia UK Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nutrient intake	Dietary intake, including the intake of all foods and fluids, will be recorded and analysed throughout the study.	4 weeks (28 days)
Secondary	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.		4 weeks (28 days)
Secondary	Tolerance: How well the child tolerates the oral nutritional supplements (including changes to gastrointestinal symptoms)		4 weeks (28 days)
Secondary	Acceptability: How acceptable the oral nutritional supplement is to the child and their parent/carer, including taste, texture, ease of use, etc.		4 weeks (28 days)
Secondary	Anthropometry	Changes to weight, height and head circumference in children less than 2yrs of age.	4 weeks (28 days)
Secondary	Safety assessed by adverse events, to be recorded throughout study.		4 weeks (28 days)