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

NCT ID: NCT05784389

Last Updated: 2023-03-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-27
• Study Completion Date: 2023-11-20

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.

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Low PRAL diet

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

Group Type: EXPERIMENTAL

Low PRAL

Intervention Type: OTHER

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

Interventions

Low PRAL

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Copenhagen

OTHER

Sponsor Role: collaborator

Nordsjaellands Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lisbet Brandi, Doctor Med

Role: PRINCIPAL_INVESTIGATOR

Nordsjaellands Hospital

Jens R Andersen, As. prof.

Role: PRINCIPAL_INVESTIGATOR

University of Copenhagen

Locations

Nordshjaellands Hospital

Hillerød, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Louise H Salomo, Doctor Med

Role: CONTACT

louise.havkrog.salomo@regionh.dk

48293392

Facility Contacts

Nordshjaellands Hospital

Role: primary

Other Identifiers

H-21069570

Identifier Type: -

Identifier Source: org_study_id