Reduction of Metabolic Acidosis in Patients With Chronic Kidney Disease in Stage 4 and 5

Not Applicable

Completed

• Conditions: Metabolic Acidosis; Kidney Diseases; Renal Insufficiency; CKD; Pre-dialysis
• Interventions: Other: Low PRAL

• Registration Number: NCT05970094
• Lead Sponsor: University of Copenhagen

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.

Study Timeline

• Study Start: 2023-03-06
• Study First Submitted: 2023-07-23
• Study First Submitted QC: 2023-07-23
• Study First Posted: 2023-08-01
• Primary Completion: 2023-08-20
• Status Verified: 2023-11
• Study Completion: 2023-11-20
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Low PRAL diet	Low PRAL	Crossover design: 1 arm consisting of three consecutive periods of two weeks (control, intervention and follow up).

Primary Outcome Measures

Name	Time	Method
Plasma-total CO2	6 weeks	mmol/l

Secondary Outcome Measures

Name	Time	Method
Plasma-creatinine	6 weeks	umol/l
Urine-potassium	6 weeks	mmol/d
Uirne-calcium	6 weeks	mmol/d
Plasma-sodium ion	6 weeks	mmol/l
Urine-phosphorous	6 weeks	mmol/d
Urine-albumin	6 weeks	mg/d
Urine-creatinine	6 weeks	mmol/d
Total acid excretion in urine	6 weeks	meqv/day
Plasma-alkaline phosphatase	6 weeks	U/l
Urine-carbamide	6 weeks	mmol/d
Plasma-carbamide	6 weeks	mmol/l
Plasma-albumin	6 weeks	g/l
Urine-pH	6 weeks	Units
Urine bicarbonate	6 weeks	mmol/l
Plasma-parathyroid hormone	6 weeks	pmol/l
Urine-sodium	6 weeks	mmol/d
Urine NH4+ excretion	6 weeks	mmol/day
Urine net acid excretion	6 weeks	meqv/day
Urine-magnesium	6 weeks	mmol/d

Trial Locations

Locations (1)

Nordshjaellands Hospital; 🇩🇰 Hillerød, Denmark