Clinical trial NCT05970094: 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: COMPLETED
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: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Nordsjaellands Hospital
First posted: 2023-08-01
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: Crossover design: 1 arm consisting of three consecutive periods of two weeks (control, intervention and follow up).
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Plasma-total 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: Uirne-calcium
timeFrame: 6 weeks
measure: Total acid excretion in urine
timeFrame: 6 weeks
measure: Urine-pH
timeFrame: 6 weeks
measure: Urine 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: University of Copenhagen
name: Jens Rikardt Andersen, MD, MPA
role: STUDY_DIRECTOR
References: