A Multicenter Study to Evaluate the Nutritional Suitability of Renastart
NCT ID: NCT02825784
Last Updated: 2024-02-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
12 participants
INTERVENTIONAL
2017-01-06
2019-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Renastart
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.
Renastart
Renastart: specially formulated to meet the unique nutritional needs of children from birth to 10 years with chronic kidney disease (CKD).
Interventions
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Renastart
Renastart: specially formulated to meet the unique nutritional needs of children from birth to 10 years with chronic kidney disease (CKD).
Eligibility Criteria
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Inclusion Criteria
2. Diagnosed with Chronic Kidney Disease
3. Requirement for a low potassium diet, as evidence by elevated serum potassium levels (\> normal reference value which is 3.5-5.0 mmol/L)
4. Requirement for a low potassium enteral formula to provide a minimum of 20% of daily energy (kcal) requirements. (calculated according to individual child's needs and according to local clinical practice)
5. Written informed consent provided by parent/primary caregiver.
6. Assent provided by child, if appropriate.
Exclusion Criteria
2. Intolerance or allergy to cow's milk or any other ingredients in Renastart.
3. Prior intolerance of Renastart formula.
4. Any disorders which in the investigator's opinion may cause significant gastrointestinal malabsorption.
5. Liver failure.
6. Active infection or presenting with any signs or symptoms of an infectious disease at screening.
7. Concurrent enrollment into another clinical trial.
10 Years
ALL
No
Sponsors
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Vitaflo International, Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Bernd Hoppe
Role: PRINCIPAL_INVESTIGATOR
Universitätsklinik Bonn
Locations
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Universitatsklinikum Bonn
Bonn, , Germany
Universitatsklinikum Koln
Cologne, , Germany
Universitatsklinikum Essen
Essen, , Germany
Countries
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Other Identifiers
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NA-REN-072013-03
Identifier Type: -
Identifier Source: org_study_id
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