Clinical Trial: High vs Standard Energy Children's Drink Study

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Nutricia UK Ltd

Current Primary Outcome: Nutrient intake [ Time Frame: 4 weeks (28 days) ]

Dietary intake, including the intake of all foods and fluids, will be recorded and analysed throughout the study.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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) ]
  • Tolerance: How well the child tolerates the oral nutritional supplements (including changes to gastrointestinal symptoms) [ Time Frame: 4 weeks (28 days) ]
  • 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) ]
  • Anthropometry [ Time Frame: 4 weeks (28 days) ]
    Changes to weight, height and head circumference in children less than 2yrs of age.
  • Safety assessed by adverse events, to be recorded throughout study. [ Time Frame: 4 weeks (28 days) ]


Original Secondary Outcome: Same as current

Information By: Nutricia UK Ltd

Dates:
Date Received: April 14, 2015
Date Started: August 2015
Date Completion:
Last Updated: October 24, 2016
Last Verified: October 2016