Clinical trial NCT05784389: Reduction of Metabolic Acidosis in Patients With Chronic Kidney Disease in Stage 4 and 5
Official title: Reduction of Metabolic Acidosis in Patients With Chronic Kidney Disease in Stage 4 and 5
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Kidney Diseases
Metabolic Acidosis
Renal Insufficiency
CKD
Pre-dialysis
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
Lead sponsor: Nordsjaellands Hospital
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2023-03-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group Assignment

Crossover design: 1 arm consisting of three consecutive periods of two weeks (control, intervention and follow up).
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Plasma-total carbon dioxide (CO2)
timeFrame: 6 weeks
Secondary outcomes:
measure: Plasma-alkaline phosphatase
timeFrame: 6 weeks
measure: Plasma-sodium ion
timeFrame: 6 weeks
measure: Plasma-creatinine
timeFrame: 6 weeks
measure: Plasma-parathyroid hormone
timeFrame: 6 weeks
measure: Plasma-carbamide
timeFrame: 6 weeks
measure: Plasma-albumin
timeFrame: 6 weeks
measure: Urine-phosphorous
timeFrame: 6 weeks
measure: Urine-sodium
timeFrame: 6 weeks
measure: Urine-potassium
timeFrame: 6 weeks
measure: Urine-carbamide
timeFrame: 6 weeks
measure: Urine-albumin
timeFrame: 6 weeks
measure: Urine-magnesium
timeFrame: 6 weeks
measure: Urine-creatinine
timeFrame: 6 weeks
measure: Urine-calcium
timeFrame: 6 weeks
measure: Total acid excretion in urine
timeFrame: 6 weeks
measure: Urine-pH
timeFrame: 6 weeks
measure: Urine ammonium-ion (NH4+) excretion
timeFrame: 6 weeks
measure: Urine net acid excretion
timeFrame: 6 weeks
measure: Urine bicarbonate
timeFrame: 6 weeks
Other outcomes:
measure: Plasma-Potassium
timeFrame: 6 weeks
measure: Plasma-calcium
timeFrame: 6 weeks
measure: Plasma-magnesium
timeFrame: 6 weeks
measure: Plasma-inorganic phosphorous
timeFrame: 6 weeks
Locations:
city: Hillerød
country: Denmark
facility: Nordshjaellands Hospital
Study officials:
affiliation: Nordsjaellands Hospital
name: Lisbet Brandi, Doctor Med
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Copenhagen
name: Jens R Andersen, As. prof.
role: PRINCIPAL_INVESTIGATOR
References: