A Multicenter Study to Evaluate the Nutritional Suitability of Renastart

Vitaflo International, Ltd12 enrolled

Overview

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Kidney Disease Hyperkalemia

Interventions

RenastartDIETARY_SUPPLEMENT

Renastart: specially formulated to meet the unique nutritional needs of children from birth to 10 years with chronic kidney disease (CKD).

Eligibility

Sex: ALLMax age: 10 Years

Medical Language ↔ Plain English

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.

Locations (3)

Universitatsklinikum Bonn

Bonn, Germany

Universitatsklinikum Koln

Cologne, Germany

Universitatsklinikum Essen

Essen, Germany

Outcomes

Primary Outcomes

Change in serum potassium level

To evaluate the nutritional suitability of Renastart, specifically in relation to management of hyperkalemia via blood tests

Time frame: Baseline, week 8, week 16

Secondary Outcomes

Change in height (cm)

To monitor the maintenance / improvement of growth over the course of the study.

Time frame: Baseline, week 8, week 16

Change in mass (kg)

To monitor the maintenance / improvement of growth over the course of the study.

Time frame: Baseline, week 8, week 16

Palatability

To evaluate the palatability of Renastart when taken orally via a patient questionnaire.

Time frame: 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.

Time frame: Throughout the 16 weeks

Compliance

To evaluate patient compliance with Renastart administration when taken orally or by enteral feeding tube via a patient questionnaire.

Time frame: Throughout the 16 weeks

Data from ClinicalTrials.gov

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