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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04579315
Other study ID # H-20026376
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 30, 2020
Est. completion date November 30, 2023

Study information

Verified date April 2024
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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Study Design


Intervention

Other:
Intervention group; NNRD group
The intervention is a whole food approach, meaning that the participants in the intervention group receives all daily food elements that they should consume

Locations

Country Name City State
Denmark Rigshospitalet Copenhagen

Sponsors (1)

Lead Sponsor Collaborator
Bo Feldt-Rasmussen

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Difference in change in 24-hour urine phosphorus excretion from baseline to week 26 between the two study groups 24-hour urine sample Baseline, day: 14, 30, 60, 90, 120, 150, 180 and three months after study completion
Secondary Difference in changes from baseline to week 26 between study groups in urinary excretion of calcium - creatinine, -urea and protein 24-hour urine sample Baseline, day: 14, 30, 60, 90, 120, 150, 180 and three months after study completion
Secondary Difference in changes from baseline to week 26 between study groups in blood lipids Blood samples Baseline, day: 14, 30, 60, 90, 120, 150, 180 and three months after study completion
Secondary 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 Baseline, day: 14, 30, 60, 90, 120, 150, 180 and three months after study completion
Secondary Difference in changes from baseline to week 26 between study groups in glomerular filtration rate, as judged by P-creatinine Blood samples Baseline, day: 14, 30, 60, 90, 120, 150, 180 and three months after study completion
Secondary Difference in changes from baseline to week 26 between study groups in weight Weight changes in kilograms Baseline, day: 30, 60, 90, 120, 150, 180 and three months after study completion
Secondary Difference in changes from baseline to week 26 between study groups in hip- and waist circumferences Hip/waist circumferences in centimeters Baseline, day: 30, 60, 90, 120, 150, 180 and three months after study completion
Secondary 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) Baseline and study completion (day 180)
Secondary 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) Baseline, day: 30, 60, 90, 120, 150, 180 and three months after study completion
Secondary 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 Baseline and study completion (day 180)
Secondary Dietary satisfaction in the intervention group 5-likert scale questionnaire. Low/high scores varies in terms of reflecting better or worse outcomes Day 30, 60, 90, 120, 150, 180
Secondary Difference in changes from baseline to week 26 between study groups in SuPAR and GDF15 Blood samples Baseline, day: 14, 30, 60, 90, 120, 150, 180 and three months after study completion
Secondary Difference in change in metabolic acidosis from baseline to week 26 between the two study groups 24-hour urine sample Baseline, day: 14, 30, 60, 90, 120, 150, 180 and three months after study completion
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