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

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.

Study Overview

• Status: Recruiting
• 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. 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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Louise H Salomo, Doctor Med; Phone Number: 48293392; Email: louise.havkrog.salomo@regionh.dk

Study Locations

• Denmark
  • Hillerød, Denmark, 3400
    • Recruiting
    • Nordshjaellands Hospital
    • Contact: Nordshjaellands Hospital
    • Sub-Investigator: Anna Elvina W Pedersen, Stud. scient
    • Sub-Investigator: Julie F Christensen, Stud. scient

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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; 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 carbon dioxide (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-calcium	mmol/d	6 weeks
Total acid excretion in urine	mmol/d	6 weeks
Urine-pH	pH	6 weeks
Urine ammonium-ion (NH4+) excretion	mmol/d	6 weeks
Urine net acid excretion	mmol/d	6 weeks
Urine bicarbonate	mmol/l	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: Nordsjaellands Hospital
• Collaborators: University of Copenhagen
• Investigators: Principal Investigator: Lisbet Brandi, Doctor Med, Nordsjaellands Hospital; Principal Investigator: Jens R Andersen, As. prof., University of Copenhagen

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2023
• Primary Completion (Anticipated): June 20, 2023
• Study Completion (Anticipated): November 20, 2023

Study Registration Dates

• First Submitted: March 13, 2023
• First Submitted That Met QC Criteria: March 13, 2023
• First Posted (Actual): March 24, 2023

Study Record Updates

• Last Update Posted (Actual): March 29, 2023
• Last Update Submitted That Met QC Criteria: March 27, 2023
• Last Verified: March 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: Metabolic Diseases; Urologic Diseases; Acid-Base Imbalance; 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: sharing is not currently possible recording to legislation and consent form.

Drug and device information, study documents

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