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
- Diseases
- Chronic kidney disease
- 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
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.