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: Recruiting

Administrative data

• NCT number: NCT05784389
• Other study ID #: H-21069570
• Status: Recruiting
• Phase: N/A
• Start date: March 27, 2023
• Est. completion date: November 20, 2023

Study information

• Verified date: March 2023
• Source: Nordsjaellands Hospital
• Contact: Louise H Salomo, Doctor Med
• Phone: 48293392
• Email: louise.havkrog.salomo[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

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

Eligibility

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

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
Nordsjaellands Hospital	University of Copenhagen

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