Reduction of Metabolic Acidosis in Patients With Chronic Kidney Disease in Stage 4 and 5 (REMA-CKD)

University of Copenhagen

Status: Completed

Conditions: Pre-dialysis; Kidney Diseases; CKD; Metabolic Acidosis; Renal Insufficiency

Treatments: Other: Low PRAL

Study type: Interventional

Funder types: Other

Identifiers

NCT05970094

H-21069570

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Low PRAL diet

Experimental group

Description:

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

Treatment:

Other: Low PRAL