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
This clinical trial aims to investigate and test the effect of an acid/base diet in chronic kidney disease (CKD) patients, CKD stage 4 and 5. The trial is guided by the hypothesis that an acid/base diet will reduce the degree of acidosis and simultaneously reduce the need for 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. Therefore, we aim to investigate this association through an interventional study design. Participants will be asked to follow a restricted diet with a low PRAL during a 6-week trial divided into three periods: two-week of free-living control, two-weeks of intervention, and a two-week free-living follow-up. The PRAL calculation tool will be used to create a diet low in acid and to develop individualized diet plans for each patient. The diet will comply with Danish national guidelines on threshold for potassium and protein, due to the high risk of hyperkalemia in CKD patients. 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
University of Copenhagen
Nordsjaellands Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single Group Assignment 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-bicarbonate 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, bricker bladder, pancreatitis or any other known malabsorption problem * Potassium above 5 mmol/l * Ongoing infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma-total carbon dioxide (CO2) | 6 weeks | mmol/l |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Urine-potassium | 6 weeks | mmol/d |
| Urine-pH | 6 weeks | pH |
| Urine ammonium-ion (NH4+) excretion | 6 weeks | mmol/d |
| Urine net acid excretion | 6 weeks | mmol/d |
| 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 |
| Urine-calcium | 6 weeks | mmol/d |
| Total acid excretion in urine | 6 weeks | mmol/d |
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
Contacts
Primary ContactLouise H Salomo, Doctor Med
Outcome results
None listed