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

Sponsor

Nordsjaellands Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05784389

Collaborator

University of Copenhagen (Other)

Enrollment

Location

Arm

7.8

Anticipated Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

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.

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-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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Single Group Assignment Crossover design: 1 arm consisting of three consecutive periods of two weeks (control, intervention and follow up).Single Group Assignment 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 27, 2023

Anticipated Primary Completion Date :

Jun 20, 2023

Anticipated Study Completion Date :

Nov 20, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Low PRAL diet 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

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 carbon dioxide (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
Urine-calcium [6 weeks]
mmol/d
Total acid excretion in urine [6 weeks]
mmol/d
Urine-pH [6 weeks]
pH
Urine ammonium-ion (NH4+) excretion [6 weeks]
mmol/d
Urine net acid excretion [6 weeks]
mmol/d
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-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