Ignite Creation Date:
2024-05-06 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 12:50 PM
Study NCT ID:
NCT03602937
Status:
COMPLETED
Last Update Posted:
2024-02-16
First Post:
2018-04-23
Brief Title:
Evaluation of Renastep
Sponsor:
Vitaflo International Ltd
Organization:
Vitaflo International Ltd
Study Overview
Official Title:
A Study to Evaluate the Acceptability and Nutritional Suitability 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
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Renastep
Brief Summary:
Evaluation of Renastep is a 28-day long prospective nutritional study that will recruit 15 patients aged between 3 and 18 years of age with Chronic Kidney Disease Participants will incorporate Renastep into their renal specific diet during which time they will record gastrointestinal symptoms adherence to recommended intakes and thoughts on its palatability A Baseline CRF completed by the Investigator at the start of the trial will record demographic information GI history and the most recent renal bio-marker results Bio-marker results recorded as part of routine care over the course of the study will be captured in the End of Study CRF
The study is designed to generate acceptability data that will be used to support an application to the Advisory Committee on Borderline Substances for Renastep to be reimbursable on prescription within the NHS
The study is designed to generate acceptability data that will be used to support an application to the Advisory Committee on Borderline Substances for Renastep to be reimbursable on prescription within the NHS
Detailed Description:
Renastep is designed for use in the dietary management of kidney disease between 3 and 18 years of age It is a high-energy liquid feed containing protein carbohydrate fat vitamins minerals trace elements and DHA It contains low levels of potassium phosphorus calcium chloride and vitamin A compared with a standard paediatric enteral feed
Vitaflo International Ltd has developed Renastep following a request from the Paediatric Renal Interest Nutrition Group PRING They requested a low potassium and phosphate high energy liquid feed for the dietary management of children with kidney disease that can be used as a sip feed or as a part of a modular tube feed
There is currently no product designed specifically for use in this age group Current dietetic practice involves either prescribing a powdered infant formula in variable concentrations or manipulating an adult renal sip feed to construct a modular feed meeting the particular individual requirements of a paediatric patient with chronic kidney disease This can be time consuming complicated can frequently involve preparation error leading to over or underconcentration of key nutrients and increases the risk of microbial contamination As Renastep is a ready to use product designed specifically for children with kidney disease it can be expected that it will be more easily incorporated into the dietary management of the patient than the current options available This has also been requested by the children and their families Renastep could replace unsafe current practices that are the only option available to clinicians
In order for Renastep to be prescribed within the NHS it must first be subject to an application to the Advisory Committee on Borderline Substances ACBS The ACBS require data on the products acceptability in terms of gastrointestinal tolerance palatability and participants adherence to recommended intakes The ACBS require such acceptability studies to be conducted in at least 15 patients for whom the product is designed This stipulation is the reason for conducting the trial within patients aged 3 - 18 years of age with Chronic Kidney Disease
The study will last for 28 days Participants will self-report study data in Daily Diary forms that include 7 days of gastrointestinal data daily records of how much of the product has been taken compared to the amount prescribed and a final evaluation of the products palatability The investigator will complete a Baseline CRF at the first visit to record demographic information GI history and the most recent urea phosphorus and potassium results This will be supplemented by an End of Study CRF which will record urea phosphorus and potassium results recorded during the trial period as part of usual clinical care Information relating to gastrointestinal tolerance of Renastep over the 28-day study period will also be recorded by the Investigator in the End of Study CRF
All study data will be anonymised and reviewed by the local investigator prior to it being forwarded to the sponsor Vitaflo International Ltd
Vitaflo International Ltd has developed Renastep following a request from the Paediatric Renal Interest Nutrition Group PRING They requested a low potassium and phosphate high energy liquid feed for the dietary management of children with kidney disease that can be used as a sip feed or as a part of a modular tube feed
There is currently no product designed specifically for use in this age group Current dietetic practice involves either prescribing a powdered infant formula in variable concentrations or manipulating an adult renal sip feed to construct a modular feed meeting the particular individual requirements of a paediatric patient with chronic kidney disease This can be time consuming complicated can frequently involve preparation error leading to over or underconcentration of key nutrients and increases the risk of microbial contamination As Renastep is a ready to use product designed specifically for children with kidney disease it can be expected that it will be more easily incorporated into the dietary management of the patient than the current options available This has also been requested by the children and their families Renastep could replace unsafe current practices that are the only option available to clinicians
In order for Renastep to be prescribed within the NHS it must first be subject to an application to the Advisory Committee on Borderline Substances ACBS The ACBS require data on the products acceptability in terms of gastrointestinal tolerance palatability and participants adherence to recommended intakes The ACBS require such acceptability studies to be conducted in at least 15 patients for whom the product is designed This stipulation is the reason for conducting the trial within patients aged 3 - 18 years of age with Chronic Kidney Disease
The study will last for 28 days Participants will self-report study data in Daily Diary forms that include 7 days of gastrointestinal data daily records of how much of the product has been taken compared to the amount prescribed and a final evaluation of the products palatability The investigator will complete a Baseline CRF at the first visit to record demographic information GI history and the most recent urea phosphorus and potassium results This will be supplemented by an End of Study CRF which will record urea phosphorus and potassium results recorded during the trial period as part of usual clinical care Information relating to gastrointestinal tolerance of Renastep over the 28-day study period will also be recorded by the Investigator in the End of Study CRF
All study data will be anonymised and reviewed by the local investigator prior to it being forwarded to the sponsor Vitaflo International Ltd
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None