High vs standard energy children’s drink study FC125
Research type
Research Study
Full title
The effect of standard versus high energy, low volume oral nutritional supplements in children requiring nutritional support – a pilot trial
IRAS ID
178139
Contact name
Katy Sorensen
Contact email
Duration of Study in the UK
2 years, 1 months, 30 days
Research summary
Due to acute and/or chronic disease, some children cannot get all the nutrition they need from food and drink and require extra nutrition such as oral nutritional supplements (ONS). There are currently some ONS available on NHS prescription for children, usually 1-1.5kcal/ml, 200ml. Some children have increased nutritional requirements or need small volumes of fluid due to a medical condition, and therefore would benefit from a high energy density, low volume ONS instead.
Nutricia is a medical nutrition company and has developed a new high energy (2.4kcal/ml), low volume (125ml) ONS (Fortini Compact). Nutricia is conducting a study to support the use of this ONS in clinical practice and to support an application to the Advisory Committee of Borderline Substances for the product to be available on NHS prescription.
The study will investigate the effects of the high energy density, low volume ONS versus standard energy density ONS, in children aged 1-12yrs requiring nutritional support. The trial will be conducted in several NHS sites across the UK and will recruit fifty eligible children. Each will be randomised into one of two study arms. Group A will be asked to take the high energy density, low volume ONS for 4 weeks (28 days); Group B will be asked to take a standard energy paediatric ONS for 4 weeks (28 days), the exact type and quantity of which will be the Investigating Dietitian's discretion. The primary outcome is nutrient intake, with secondary outcomes of ONS compliance, tolerance, acceptability, anthropometry and safety. Data will be collected using questionnaires. There are no invasive measures in this study.
Nutricia will be funding the research. The aim is to collect data to support this new ONS and obtain approval by the ACBS for use on NHS prescription. The ONS are 'Foods for Special Medical Purposes' and are MHRA exempt.
REC name
London - Surrey Research Ethics Committee
REC reference
15/LO/0802
Date of REC Opinion
10 Jun 2015
REC opinion
Further Information Favourable Opinion