Chronic Kidney Disease, Hyperkalemia
Conditions
Keywords
potassium chronic kidney disease CKD children
Brief summary
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)
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTRenastart
Renastart: specially formulated to meet the unique nutritional needs of children from birth to 10 years with chronic kidney disease (CKD).
Sponsors
Vitaflo International, Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 10 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 10 years or under at the time of enrolment into the study. 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
1. Receiving total parenteral nutrition (TPN). 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in serum potassium level | Baseline, week 8, week 16 | To evaluate the nutritional suitability of Renastart, specifically in relation to management of hyperkalemia via blood tests |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in height (cm) | Baseline, week 8, week 16 | To monitor the maintenance / improvement of growth over the course of the study. |
| Change in mass (kg) | Baseline, week 8, week 16 | To monitor the maintenance / improvement of growth over the course of the study. |
| Palatability | Throughout the 16 weeks | To evaluate the palatability of Renastart when taken orally via a patient questionnaire. |
| Gastrointestinal tolerance | Throughout the 16 weeks | To evaluate the GI tolerance of Renastart when taken orally or by enteral feeding tube via a patient questionnaire. |
| Compliance | Throughout the 16 weeks | To evaluate patient compliance with Renastart administration when taken orally or by enteral feeding tube via a patient questionnaire. |
Countries
Germany
Outcome results
None listed