An interventional study of Intervention group; NNRD group in Chronic Kidney Disease(CKD), Hyperphosphatemia and Blood Pressure, sponsored by Bo Feldt-Rasmussen. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-12.
Sponsored by Bo Feldt-Rasmussen · Not applicable, Interventional, and Treatment
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.
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:
Baseline (day 0)
Written consent will be obtained, randomization will be performed, and the following data will be registered:
Day 30, 60, 90, 120, 150
Every 4th week during the study period of 26 weeks (a total of 6 times) all patients will be evaluated at the Department of Nephrology, University Hospital, Copenhagen. During these first 5 visits the following data will be gathered:
Day 180 (study completion)
During the last day of the study period, the patients will be asked to meet at Rigshospitalet one more time. Data as on day 30, 60, 90, 120 and 150 will be gathered, moreover the following information will be obtained:
3,090 studies on the registry are indexed under Renal Insufficiency, Chronic; 698 are open to participants now.
This study's enrollment of 60 is below the median of 73 across 2,157 interventional studies indexed under Renal Insufficiency, Chronic.
Browse Renal Insufficiency, Chronic studies →Bo Feldt-Rasmussen is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Main principles of the interventional whole food approach are: * Maximum of 850 mg phosphorous/day * Protein: 0.8 g/kg/day * 80% vegetable products; 20% animal products * Maximum of 5-7 g NaCl/day (table salt) * Fresh raw products * Seasonal oriented * Fish: At least once a week * Vegetarian: At least once a week * Wide range of fruit and vegetables * Easy to follow in daily practice * Rich in flavors * Sufficient content of micro- and macronutrients
Other: Intervention group; NNRD group
There is no intervention, patients are following their habitual diet
The intervention is a whole food approach, meaning that the participants in the intervention group receives all daily food elements that they should consume
Difference in change in 24-hour urine phosphorus excretion from baseline to week 26 between the two study groups
24-hour urine sample
Time frame: 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 urinary excretion of calcium - creatinine, -urea and protein
24-hour urine sample
Time frame: 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
Blood samples
Time frame: 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
Blood samples
Time frame: 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 glomerular filtration rate, as judged by P-creatinine
Blood samples
Time frame: 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
Weight changes in kilograms
Time frame: 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
Hip/waist circumferences in centimeters
Time frame: 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)
Body composition, focusing on bone mineral density using DEXA scan (Dual-energy X-ray absorptiometry)
Time frame: Baseline and study completion (day 180)
Difference in changes from baseline to week 26 between study groups in blood pressure, both systolic and diastolic blood pressure
Blood pressure mm Hg (systolic and diastolic)
Time frame: 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
Scale EQ-5D-5L questionnaire. Low/high scores varies in terms of reflecting better or worse outcomes
Time frame: Baseline and study completion (day 180)
Dietary satisfaction in the intervention group
5-likert scale questionnaire. Low/high scores varies in terms of reflecting better or worse outcomes
Time frame: Day 30, 60, 90, 120, 150, 180
Difference in changes from baseline to week 26 between study groups in SuPAR and GDF15
Blood samples
Time frame: 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
24-hour urine sample
Time frame: Baseline, day: 14, 30, 60, 90, 120, 150, 180 and three months after study completion
Plan to share: No — There is no current plan to make IPD available
Ran from Nov 2020 to primary completion in Aug 2022, 21 months.
Of 576 non-industry interventional studies with no phase under Renal Insufficiency, Chronic, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 45. This study's 21 months is close to that.
Counting every sponsor, half of 616 studies reached it within 23 months; a quarter within 10 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Bo Feldt-Rasmussen