CKD, Kidney Diseases, Metabolic Acidosis, Pre-dialysis, Renal Insufficiency
Conditions
Keywords
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
Brief summary
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
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.
Interventions
OTHERLow PRAL
Two weeks on a low PRAL diet compared to 2 week free living
Sponsors
Nordsjaellands Hospital
University of Copenhagen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Crossover design: 1 arm consisting of three consecutive periods of two weeks (control, intervention and follow up).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma-total CO2 | 6 weeks | mmol/l |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Urine-potassium | 6 weeks | mmol/d |
| Urine-pH | 6 weeks | Units |
| Urine NH4+ excretion | 6 weeks | mmol/day |
| Urine net acid excretion | 6 weeks | meqv/day |
| Urine bicarbonate | 6 weeks | mmol/l |
| Plasma-alkaline phosphatase | 6 weeks | U/l |
| Plasma-sodium ion | 6 weeks | mmol/l |
| Plasma-creatinine | 6 weeks | umol/l |
| Plasma-parathyroid hormone | 6 weeks | pmol/l |
| Plasma-carbamide | 6 weeks | mmol/l |
| Plasma-albumin | 6 weeks | g/l |
| Urine-phosphorous | 6 weeks | mmol/d |
| Urine-sodium | 6 weeks | mmol/d |
| Urine-carbamide | 6 weeks | mmol/d |
| Urine-albumin | 6 weeks | mg/d |
| Urine-magnesium | 6 weeks | mmol/d |
| Urine-creatinine | 6 weeks | mmol/d |
| Uirne-calcium | 6 weeks | mmol/d |
| Total acid excretion in urine | 6 weeks | meqv/day |
Other
| Measure | Time frame | Description |
|---|---|---|
| Plasma-magnesium | 6 weeks | mmol/l |
| Plasma-inorganic phosphorous | 6 weeks | mmol/l |
| Plasma-Potassium | 6 weeks | mmol/l |
| Plasma-calcium | 6 weeks | mmol/l |
Countries
Denmark
Outcome results
None listed