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

Kidney Diseases Clinical Trial

— REMA-CKD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05970094
• Other study ID #: H-21069570
• Status: Completed
• Phase: N/A
• Start date: March 6, 2023
• Est. completion date: November 20, 2023

Study information

• Verified date: November 2023
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 20, 2023
• Est. primary completion date: August 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acidosis
• CKD
• Kidney Diseases
• Metabolic Acidosis
• Pre-dialysis
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Other:
• Low PRAL
Two weeks on a low PRAL diet compared to 2 week free living

Locations

Country	Name	City	State
Denmark	Nordshjaellands Hospital	Hillerød

Sponsors (2)

Lead Sponsor	Collaborator
University of Copenhagen	Nordsjaellands Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Plasma-Potassium	mmol/l	6 weeks
Other	Plasma-calcium	mmol/l	6 weeks
Other	Plasma-magnesium	mmol/l	6 weeks
Other	Plasma-inorganic phosphorous	mmol/l	6 weeks
Primary	Plasma-total CO2	mmol/l	6 weeks
Secondary	Plasma-alkaline phosphatase	U/l	6 weeks
Secondary	Plasma-sodium ion	mmol/l	6 weeks
Secondary	Plasma-creatinine	umol/l	6 weeks
Secondary	Plasma-parathyroid hormone	pmol/l	6 weeks
Secondary	Plasma-carbamide	mmol/l	6 weeks
Secondary	Plasma-albumin	g/l	6 weeks
Secondary	Urine-phosphorous	mmol/d	6 weeks
Secondary	Urine-sodium	mmol/d	6 weeks
Secondary	Urine-potassium	mmol/d	6 weeks
Secondary	Urine-carbamide	mmol/d	6 weeks
Secondary	Urine-albumin	mg/d	6 weeks
Secondary	Urine-magnesium	mmol/d	6 weeks
Secondary	Urine-creatinine	mmol/d	6 weeks
Secondary	Uirne-calcium	mmol/d	6 weeks
Secondary	Total acid excretion in urine	meqv/day	6 weeks
Secondary	Urine-pH	Units	6 weeks
Secondary	Urine NH4+ excretion	mmol/day	6 weeks
Secondary	Urine net acid excretion	meqv/day	6 weeks
Secondary	Urine bicarbonate	mmol/l	6 weeks