Long-term Effects of the New Nordic Renal Diet on Phosphorus and Lipid Homeostasis in Patients With Chronic Kidney Disease, Stages 3 and 4 - A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Difference in change in 24-hour urine phosphorus excretion from baseline to week 26 between the two study groups
研究概览
简要总结
As Chronic Kidney Disease (CKD) progresses normophosphatemia is maintained by increasing the per nephron urinary phosphorus excretion. Clinically, hyperphosphatemia is associated with high mortality, vascular calcification, endothelial dysfunction and progression of left ventricular hypertrophy. Currently the treatment of hyperphosphatemia is first being initiated in stage 5 and consists of dietetic guidance to avoid dietary phosphate and treatment with oral phosphate binders. However, studies have shown important side effects to phosphate binders in terms of progression of vascular calcifications. Therefore, it might be beneficial to start the dietetic treatment with a reduction of dietary phosphate earlier in the disease stage.
The aim of this project is to develop a New Nordic Renal Diet (NNRD) for CKD patients' stage 3-4 and to examine the long-term effects in a period of 26-weeks. NNRD has a high content of vegetable foods, less animal products and more local food items with a lesser content of phosphorus.
详细描述
This study is a randomized controlled trial performed at Department of Nephrology Rigshospitalet, Copenhagen Denmark. Sixty patients will be randomized to either 26 weeks on the NNRD (intervention) or 26 weeks on their habitual diet (control). The patients will be randomized by blinded drawing by lot. The study participants can leave the trial at any time during the study period, without any explanation. The investigator can at any time pull a patient out of the trial, if there is concern for the patient's safety or if there is a breach in terms of following the protocol. The principal investigator is required to document and report dropouts from the study.
The project group has entered a cooperation agreement with Danish chefs. The agreement involves that a team consisting of highly talented chefs will create the recipes for the intervention. The recipes will be created in close collaboration with the principal investigator who will use her expertise within Clinical Nutrition to combine the international nutrients guidelines and culinarian experiences. Moreover, the agreement holds that they will find the raw materials needed for the recipes and deliver them weekly to the patients' homes throughout the study period in packages containing the recipes and raw materials. There will be no financial costs for the patients. The patients in the intervention group are expected to follow the recipes five days of the week during the study period. The final two days of the week, the patients must plan their own meals. However, still following the recommended guidelines upon the NNRD whole food approach delivered from the principal investigator, who is a phd.-student and also a registered clinical dietitian and MSc in clinical nutrition (Nikita Misella Hansen).
Sample size calculation and statistical analysis:
The sample size calculation is based on results from previous studies performed by this study group. Within 6 months of participating in this study we expect a decrease in eGFR to be about 1 ml/min/1.73 m2. This will have no influence on the total amount of 24-h urine phosphorus excretion (primary endpoint), as CKD progresses normophosphatemia is maintained by increasing the per nephron urinary phosphorus excretion stimulated by an increase in FGF23 and PTH leading to progressively increasing plasma levels of FGF23 and SHP the "phospho-toxicity model hypothesis" to a compensation from PTH and FGF23. In a randomized controlled study with a type-1-error risk of 0.05 (alfa, two tailed) and a power of 80% (beta) with a standard deviation of 24-h urine phosphorus excretion of 200 mg and a minimum clinical relevant difference of 300 mg the study population is estimated to 21 in each group. In case of drop-outs we will include 30 participants in each group. Therefore, total number of patients to be included in this study is 60.
Timeline for the study:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Estimated glomerular filtration rate (eGFR) 20-45 ml/min
- •Medically stable for two months prior to study start
- •Written and verbally information is given
- •Read, speak and understands Danish
- •Written consent
排除标准
- •Treatment with phosphate binders
- •Metabolic disorders that requires specific dietary regulation
- •Treatment with chemotherapy within the past 6 months
- •Pregnancy and breastfeeding
- •Food allergies
结局指标
主要结局
Difference in change in 24-hour urine phosphorus excretion from baseline to week 26 between the two study groups
时间窗: Baseline, day: 14, 30, 60, 90, 120, 150, 180 and three months after study completion
24-hour urine sample
次要结局
- Difference in changes from baseline to week 26 between study groups in urinary excretion of calcium - creatinine, -urea and protein(Baseline, day: 14, 30, 60, 90, 120, 150, 180 and three months after study completion)
- Difference in changes from baseline to week 26 between study groups in blood lipids(Baseline, day: 14, 30, 60, 90, 120, 150, 180 and three months after study completion)
- Difference in changes from baseline to week 26 between study groups in SuPAR and GDF15(Baseline, day: 14, 30, 60, 90, 120, 150, 180 and three months after study completion)
- Difference in change in metabolic acidosis from baseline to week 26 between the two study groups(Baseline, day: 14, 30, 60, 90, 120, 150, 180 and three months after study completion)
- Difference in changes from baseline to week 26 between study groups in FGF23, Fractional excretion of phosphorus, P-phosphate, P-calcium, P-PTH, P-1,25OH2vitamin D3 and P-albumin(Baseline, day: 14, 30, 60, 90, 120, 150, 180 and three months after study completion)
- Difference in changes from baseline to week 26 between study groups in blood pressure, both systolic and diastolic blood pressure(Baseline, day: 30, 60, 90, 120, 150, 180 and three months after study completion)
- Difference in changes from baseline to week 26 between study groups in quality of life(Baseline and study completion (day 180))
- Difference in changes from baseline to week 26 between study groups in glomerular filtration rate, as judged by P-creatinine(Baseline, day: 14, 30, 60, 90, 120, 150, 180 and three months after study completion)
- Difference in changes from baseline to week 26 between study groups in weight(Baseline, day: 30, 60, 90, 120, 150, 180 and three months after study completion)
- Difference in changes from baseline to week 26 between study groups in hip- and waist circumferences(Baseline, day: 30, 60, 90, 120, 150, 180 and three months after study completion)
- Difference in changes from baseline to week 26 between study groups in bone mineral density using DEXA scan (Dual-energy X-ray absorptiometry)(Baseline and study completion (day 180))
- Dietary satisfaction in the intervention group(Day 30, 60, 90, 120, 150, 180)
研究者
Bo Feldt-Rasmussen
Professor, MD, DMSc
Rigshospitalet, Denmark