A Multicenter Study to Evaluate the Nutritional Suitability of Renastart (Renastart)
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|ClinicalTrials.gov Identifier: NCT02825784|
Recruitment Status : Recruiting
First Posted : July 7, 2016
Last Update Posted : September 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Chronic Kidney Disease Hyperkalemia||Dietary Supplement: Renastart||Not Applicable|
A multicenter, open label, uncontrolled study to evaluate the acceptability, tolerability, and nutritional suitability of a medical food (Renastart, Vitaflo International Ltd) specially formulated to meet the unique nutritional needs of children from birth to 10 years with chronic kidney disease (CKD)
Primary Objective To investigate the nutritional suitability of Renastart in children aged 10 years and under with CKD, particularly with respect to the dietary management of hyperkalemia and the maintenance / improvement of growth.
Secondary Objectives To investigate the acceptance, compliance, palatability, and tolerance of Renastart in children aged under 10 years with CKD.
A total of 15 children with CKD will be enrolled in the study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Open Label, Uncontrolled Study to Evaluate the Acceptability, Tolerability and Nutritional Suitability of Renastart: Specially Formulated to Meet the Unique Nutritional Needs From Birth to 10 Years With Chronic Kidney Disease|
|Actual Study Start Date :||January 6, 2017|
|Estimated Primary Completion Date :||December 31, 2018|
|Estimated Study Completion Date :||December 31, 2018|
Compared to cows' milk and/or standard pediatric enteral feeds, Renastart has the following additional nutritional features that are beneficial in children with CKD: lower phosphorus, calcium and vitamin A. The powder presentation allows flexibility with dilutions to facilitate the provision of adequate energy and protein to support growth in children with CKD.
For each subject, the recommended daily intake of Renastart is determined by the dietitian in collaboration with the local PI and primary nephrologist based on individual nutritional requirements, specifically dietary intake of potassium and serum potassium levels.
Renastart is to be given by the clinician and based on clinical and nutritional needs. Standard preparation guidelines can be found on the Renastart label.
Dietary Supplement: Renastart
Renastart: specially formulated to meet the unique nutritional needs of children from birth to 10 years with chronic kidney disease (CKD).
- Change in serum potassium level [ Time Frame: Baseline, week 8, week 16 ]To evaluate the nutritional suitability of Renastart, specifically in relation to management of hyperkalemia via blood tests
- Change in height (cm) [ Time Frame: Baseline, week 8, week 16 ]To monitor the maintenance / improvement of growth over the course of the study.
- Change in mass (kg) [ Time Frame: Baseline, week 8, week 16 ]To monitor the maintenance / improvement of growth over the course of the study.
- Palatability [ Time Frame: Throughout the 16 weeks ]To evaluate the palatability of Renastart when taken orally via a patient questionnaire.
- Gastrointestinal tolerance [ Time Frame: Throughout the 16 weeks ]To evaluate the GI tolerance of Renastart when taken orally or by enteral feeding tube via a patient questionnaire.
- Compliance [ Time Frame: Throughout the 16 weeks ]To evaluate patient compliance with Renastart administration when taken orally or by enteral feeding tube via a patient questionnaire.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02825784
|Contact: Tom Barker||0151 709 9020 ext 273||TomBarker@Vitaflo.co.uk|
|Contact: Maura O'Donnell||0151 702 4933||Maura.ODonnell@Vitaflo.co.uk|
|Contact: Bernd Hoppe +49 228 287 33194 Bernd.Hoppe@Ukb.Uni-Bonn.De|
|Contact: Christina Taylan +49 221 478 4319 Christina.Taylan@Uk-Koeln.De|
|Contact: Rainer Büscher +49 201 723 2738 Rainer.Buescher@Uk-Essen.De|
|Principal Investigator:||Bernd Hoppe||Universitätsklinik Bonn|