Evaluation of Renastep
Research type
Research Study
Full title
A study to evaluate the acceptability of Renastep, a food for special medical purposes (FSMP) for use in the dietary management of patients from 3-18 years of age with Chronic Kidney Disease (CKD)
IRAS ID
236551
Contact name
Caroline Anderson
Contact email
Sponsor organisation
Vitaflo (International) Ltd
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Renastep is a new nutritional product designed to help with the dietary management of chronic kidney disease (CKD) in children. Kidney disease has a significant effect on metabolism and nutritional intake and it has been shown that early and appropriate nutritional intervention may improve both growth and mortality in CKD patients (National Kidney Foundation 2009, Kyle, Shekerdemian et al. 2015)). Children with CKD often have growth delay for a number of reasons, including poor nutritional intake. Normal growth and development is a goal of paediatric CKD management and despite optimal management most children do not reach their genetic height potential (Royle 2015).
Nutritional management requires attention to be paid to the following factors:
• Adequacy of energy intake
• Regulation of protein intake
• Dietary restrictions e.g. potassium, fluid and electrolytes
• Regulation of phosphorus and calcium intake
• Adequacy of micronutrient and iron intake (Royle 2015)Renastep has been developed with these factors in mind following a request from the Paediatric Renal Interest Nutrition Group (PRING). They requested a low potassium, high energy liquid feed for the dietary management of children with kidney disease that can be used a sip feed or as a part of a modular tube feed.
We will provide participants with a supply of Renastep and ask them to take a amount set by their dietitian each day. The study will last for 28 days. Using daily study diaries given to the participants, or their parent(s)/guardian(s) if under 16 years of age, the study will measure participants' gastrointestinal tolerance of the product, adherence to recommended intakes as well as views on its palatability/acceptability. This information will be used to support an application to the UK Advisory Committee on Borderline Substances (ACBS) for Renastep to be prescribable within the NHS.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
18/NW/0018
Date of REC Opinion
6 Feb 2018
REC opinion
Favourable Opinion