A Multicenter, Open Label, Uncontrolled Study to Evaluate the Acceptability, Tolerability and Nutritional Suitability of Renastart: Specially Formulated to Meet the Unique Nutritional Needs From Birth to 10 Years With Chronic Kidney Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 3
- 主要终点
- Change in serum potassium level
研究概览
简要总结
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)
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 10 years or under at the time of enrolment into the study.
- •Diagnosed with Chronic Kidney Disease
- •Requirement for a low potassium diet, as evidence by elevated serum potassium levels (> normal reference value which is 3.5-5.0 mmol/L)
- •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)
- •Written informed consent provided by parent/primary caregiver.
- •Assent provided by child, if appropriate.
排除标准
- •Receiving total parenteral nutrition (TPN).
- •Intolerance or allergy to cow's milk or any other ingredients in Renastart.
- •Prior intolerance of Renastart formula.
- •Any disorders which in the investigator's opinion may cause significant gastrointestinal malabsorption.
- •Liver failure.
- •Active infection or presenting with any signs or symptoms of an infectious disease at screening.
- •Concurrent enrollment into another clinical trial.
结局指标
主要结局
Change in serum potassium level
时间窗: Baseline, week 8, week 16
To evaluate the nutritional suitability of Renastart, specifically in relation to management of hyperkalemia via blood tests
次要结局
- Change in mass (kg)(Baseline, week 8, week 16)
- Compliance(Throughout the 16 weeks)
- Change in height (cm)(Baseline, week 8, week 16)
- Gastrointestinal tolerance(Throughout the 16 weeks)
- Palatability(Throughout the 16 weeks)