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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)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Renastart | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Renastart | Dietary Supplement | Renastart: specially formulated to meet the unique nutritional needs of children from birth to 10 years with chronic kidney disease (CKD). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum potassium level | To evaluate the nutritional suitability of Renastart, specifically in relation to management of hyperkalemia via blood tests | Baseline, week 8, week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in height (cm) | To monitor the maintenance / improvement of growth over the course of the study. | Baseline, week 8, week 16 |
| Change in mass (kg) | To monitor the maintenance / improvement of growth over the course of the study. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bernd Hoppe | Universitätsklinik Bonn | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitatsklinikum Bonn | Bonn | Germany | ||||
| Universitatsklinikum Koln |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D006947 | Hyperkalemia |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| Baseline, week 8, week 16 |
| Palatability | To evaluate the palatability of Renastart when taken orally via a patient questionnaire. | Throughout the 16 weeks |
| Gastrointestinal tolerance | To evaluate the GI tolerance of Renastart when taken orally or by enteral feeding tube via a patient questionnaire. | Throughout the 16 weeks |
| Compliance | To evaluate patient compliance with Renastart administration when taken orally or by enteral feeding tube via a patient questionnaire. | Throughout the 16 weeks |
| Cologne |
| Germany |
| Universitatsklinikum Essen | Essen | Germany |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |