Reduction of Metabolic Acidosis in Patients With Chronic Kidney Disease in Stage 4 and 5

Study Overview
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Brief Summary
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The goal of this clinical trial is to learn about and test the effect of an acid/base diet, in chronic kidney patients with CKD stage 4 and 5 in an interventional study with a historical control. The hypothesize is, that an acid/base diet will reduce the degree of acidosis and the need for oral bicarbonate supplements.

Detailed Description
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Observational studies indicate that diets with a low potential renal acid load (PRAL) is associated with a lower serum-bicarbonate value. The aim is to investigate this association with an interventional studydesign. Participants will be asked to follow a restricted diet with a low PRAL during a 6 week trial divided in three periodes: two week free living control, two week intervention and a two week free living follow-up. The PRAL calculation tool will be used to create a diet low in acid, based on this the patients will receive individual diet plans. The diet will comply with national treshold guidelines for potassium and protein, this is due to the high risk of hyperkalemia in patients with chronic kidney disease. The patients will be asked to document their food and drink intake by taking pictures of their plates and cups before and after a meal, over a 24 hour period.

Official Title
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Reduction of Metabolic Acidosis in Patients With Chronic Kidney Disease in Stage 4 and 5

Conditions
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CKD, Kidney Diseases, Metabolic Acidosis, Renal Insufficiency, Pre-dialysis

Intervention / Treatment
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* Other: Low PRAL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic acidosis (plasma-bicarbonat under 22 mmol/l at multiple measures within the last 12 months). Diagnosed with non-dialysis needed chronic kidney disease in stage 4 and 5 (eGFR below 30 ml/min/1,73 m2) Of legal age and over 18 of years Understand danish and understand the written material Able to cooperate about the diet Able to take pictures with their phone or willing to learn Exclusion Criteria: Vegan and vegetarian with very low intake of animal protein (below 25 g/day) Pregnant or breast feeding Patients with short bowel syndrome, brickre's bladder, pancreatitis or any other known malabsorption problem Potassium above 5 mmol/l Ongoing infection

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Crossover design: 1 arm consisting of three consecutive periods of two weeks (control, intervention and follow up).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low PRAL diet<br>Crossover design: 1 arm consisting of three consecutive periods of two weeks (control, intervention and follow up). | Other: Low PRAL<br>* Two weeks on a low PRAL diet compared to 2 week free living<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma-total CO2 | mmol/l | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma-alkaline phosphatase | U/l | 6 weeks | 
| Plasma-sodium ion | mmol/l | 6 weeks | 
| Plasma-creatinine | umol/l | 6 weeks | 
| Plasma-parathyroid hormone | pmol/l | 6 weeks | 
| Plasma-carbamide | mmol/l | 6 weeks | 
| Plasma-albumin | g/l | 6 weeks | 
| Urine-phosphorous | mmol/d | 6 weeks | 
| Urine-sodium | mmol/d | 6 weeks | 
| Urine-potassium | mmol/d | 6 weeks | 
| Urine-carbamide | mmol/d | 6 weeks | 
| Urine-albumin | mg/d | 6 weeks | 
| Urine-magnesium | mmol/d | 6 weeks | 
| Urine-creatinine | mmol/d | 6 weeks | 
| Uirne-calcium | mmol/d | 6 weeks | 
| Total acid excretion in urine | meqv/day | 6 weeks | 
| Urine-pH | Units | 6 weeks | 
| Urine NH4+ excretion | mmol/day | 6 weeks | 
| Urine net acid excretion | meqv/day | 6 weeks | 
| Urine bicarbonate | mmol/l | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Potential renal acid load, PRAL, Study design, Diet, Humans, Elderly, Bicarbonate/blood, Muscle strength, Hand strength, Chair stand test, Calorimetry, indirect, Bone mineralization, Carbon dioxide/blood, Phosphor/urine, Potassium/urine, Urea/blood, Urea/urine