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

Sponsor

University of Copenhagen (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05970094

Collaborator

Nordsjaellands Hospital (Other)

Enrollment

Location

Arm

8.5

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

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.

Our hypothesize is that an acid/base diet will reduce the degree of acidosis and the need for oral bicarbonate supplements.

Condition or Disease	Intervention/Treatment	Phase
Kidney Diseases Metabolic Acidosis Renal Insufficiency CKD Pre-dialysis	Other: Low PRAL	N/A

Detailed Description

Observational studies indicate that diets with a low "potential renal acid load (PRAL)" is associated with a lower serum-bicarobante value. Therefore we aim 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 recieve individual diet plans. The diet will comply with national treshold guidlines 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 Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 6, 2023

Anticipated Primary Completion Date :

Aug 20, 2023

Anticipated Study Completion Date :

Nov 20, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Low PRAL diet Crossover design: 1 arm consisting of three consecutive periods of two weeks (control, intervention and follow up).	Other: Low PRAL Two weeks on a low PRAL diet compared to 2 week free living

Arm

Intervention/Treatment

Experimental: Low PRAL diet

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

Other: Low PRAL

Two weeks on a low PRAL diet compared to 2 week free living

Outcome Measures

Primary Outcome Measures

Plasma-total CO2 [6 weeks]
mmol/l

Secondary Outcome Measures

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-potassium [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
Uirne-calcium [6 weeks]
mmol/d
Total acid excretion in urine [6 weeks]
Urine-pH [6 weeks]
Urine NH4+ excretion [6 weeks]
Urine net acid excretion [6 weeks]
Urine bicarbonate [6 weeks]
mmol/l

Other Outcome Measures

Plasma-Potassium [6 weeks]
mmol/l
Plasma-calcium [6 weeks]
mmol/l
Plasma-magnesium [6 weeks]
mmol/l
Plasma-inorganic phosphorous [6 weeks]
mmol/l

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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