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NCT04579315Completed

Long-term Effects of the New Nordic Renal Diet in Patients With Moderate Chronic Kidney Disease

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

Source: ClinicalTrials.gov · Last updated 12 Apr 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
60 (actual)
First submitted
1 Oct 2020
Start date
30 Nov 2020
Primary completion date
30 Aug 2022
Lead sponsor
Bo Feldt-Rasmussen
NCT number
NCT04579315

What you commit to

  • Study type: Interventional
  • Participants enrolled: 60
  • From 30 Nov 2020 to the primary completion date, 30 Aug 2022
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Treatment with phosphate binders
  • Treatment with chemotherapy within the past 6 months

Other illness

  • Metabolic disorders that requires specific dietary regulation
  • Food allergies

Other

  • Pregnancy and breastfeeding
  • Vegans

Who the study is looking for

  • Age \>18
  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Rigshospitalet
Coordinator of this site? Confirm its status
CopenhagenDenmarkUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.