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

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.

Study Overview

• Status: Completed
• Conditions: Kidney Diseases; Renal Insufficiency; CKD; Metabolic Acidosis; Pre-dialysis
• Intervention / Treatment: Other: Low PRAL

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Hillerød, Denmark, 3400
    • Nordshjaellands Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma-total CO2	mmol/l	6 weeks

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma-Potassium	mmol/l	6 weeks
Plasma-calcium	mmol/l	6 weeks
Plasma-magnesium	mmol/l	6 weeks
Plasma-inorganic phosphorous	mmol/l	6 weeks

Collaborators and Investigators

• Sponsor: University of Copenhagen
• Collaborators: Nordsjaellands Hospital
• Investigators: Study Director: Jens Rikardt Andersen, MD, MPA, University of Copenhagen

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2023
• Primary Completion (Actual): August 20, 2023
• Study Completion (Actual): November 20, 2023

Study Registration Dates

• First Submitted: July 23, 2023
• First Submitted That Met QC Criteria: July 23, 2023
• First Posted (Actual): August 1, 2023

Study Record Updates

• Last Update Posted (Actual): December 4, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Elderly; Humans; Diet; Muscle strength; Hand strength; Calorimetry, indirect; Bone mineralization; Potential renal acid load; PRAL; Study design; Bicarbonate/blood; Chair stand test; Carbon dioxide/blood; Phosphor/urine; Potassium/urine; Urea/blood; Urea/urine
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Urologic Diseases; Disease Attributes; Acid-Base Imbalance; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Acidosis
• Other Study ID Numbers: H-21069570

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Currently no plans for sharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No