A Multicenter Study to Evaluate the Nutritional Suitability of Renastart

Vitaflo

Status: Completed

Conditions: Chronic Kidney Disease; Hyperkalemia

Treatments: Dietary Supplement: Renastart

Study type: Interventional

Funder types: Industry

Identifiers

NCT02825784

NA-REN-072013-03

Details and patient eligibility

About

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)

Full 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.

Enrollment: 12 patients

Sex: All

Ages: Under 10 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Renastart

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Renastart