Explorative Study to Investigate the Acid-base Response to Sodium and Potassium Salts in Patients With Chronic Kidney Disease.

NCT06237712 | Active Not Recruiting

• 1 other identifier: NL84462.078.23
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

With this research the investigators want to study how patients with chronic kidney disease respond to different sodium- and potassium salts. Potassium salts can prevent kidney damage and cardiovascular disease, however patients with chronic kidney disease can responds differently. Extra potassium can increase the amount of potassium in the blood and extra chloride can cause acidosis. With this study the investigators will gain more insight in how patients with chronic kidney disease respond to sodium and potassium salts and which one is more favorable.This information can then be used to guide the application of salt substitutes and dietary adjustments in patients with chronic kidney disease.

Conditions

Metabolic Acidosis; CKD; Electrolyte and Fluid Balance Conditions

Outcome Measures

Primary Outcomes (1)

• Plasma bicarbonate by blood draw

  The absolute difference per treatment group in measured plasma bicarbonate after treatment. After each treatment of 5 days, plasma bicarbonate will be measured by blood sampling. The difference between the groups (treatments) will be the main outcome and comparator.

  After 5 days of intervention

Secondary Outcomes (8)

• Plasma electrolyte levels

  After 5 days of intervention

• Urinary citrate

  After 5 days of intervention

• Urinary ammonia

  After 5 days of intervention

• Titratable acid

  After 5 days of intervention

• Net acid excretion

  After 5 days of intervention

Study Arms (6)

Sodium chloride

ACTIVE COMPARATOR

40 mmol of oral sodium chloride daily for 5 days

Dietary Supplement: Dietary supplement consisting of 40 mmol/daily of sodium chloride

Sodium bicarbonate

ACTIVE COMPARATOR

40 mmol of oral sodium bicarbonate daily for 5 days

Dietary Supplement: Dietary supplement consisting of 40 mmol/daily of sodium bicarbonate

Potassium chloride

ACTIVE COMPARATOR

40 mmol of oral potassium chloride daily for 5 days

Dietary Supplement: Dietary supplement consisting of 40 mmol/daily of potassium chloride

Potassium bicarbonate

ACTIVE COMPARATOR

40 mmol of oral potassium bicarbonate daily for 5 days

Dietary Supplement: Dietary supplement consisting of 40 mmol/daily of potassium bicarbonate

Potassium gluconate

ACTIVE COMPARATOR

40 mmol of oral potassium gluconate daily for 5 days

Dietary Supplement: Dietary supplement consisting of 40 mmol/daily of potassium gluconate

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo caps

Interventions

Dietary supplement consisting of 40 mmol/daily of potassium chloride DIETARY_SUPPLEMENT

The supplements are delivered in plain vegetable 00 caps, stabelizing additives are potatostarch, sunflower lecithine and sunflower oil. The capsuels are free of titanium oxide and suited for human consumption.

Potassium chloride

Dietary supplement consisting of 40 mmol/daily of potassium gluconate DIETARY_SUPPLEMENT

The supplements are delivered in plain vegetable 00 caps, stabelizing additives are potatostarch, sunflower lecithine and sunflower oil. The capsuels are free of titanium oxide and suited for human consumption.

Potassium gluconate

Dietary supplement consisting of 40 mmol/daily of potassium bicarbonate DIETARY_SUPPLEMENT

The supplements are delivered in plain vegetable 00 caps, stabelizing additives are potatostarch, sunflower lecithine and sunflower oil. The capsuels are free of titanium oxide and suited for human consumption.

Potassium bicarbonate

Dietary supplement consisting of 40 mmol/daily of sodium chloride DIETARY_SUPPLEMENT

The supplements are delivered in plain vegetable 00 caps, stabelizing additives are potatostarch, sunflower lecithine and sunflower oil. The capsuels are free of titanium oxide and suited for human consumption.

Sodium chloride

Dietary supplement consisting of 40 mmol/daily of sodium bicarbonate DIETARY_SUPPLEMENT

The supplements are delivered in plain vegetable 00 caps, stabelizing additives are potatostarch, sunflower lecithine and sunflower oil. The capsuels are free of titanium oxide and suited for human consumption.

Sodium bicarbonate

Placebo caps DIETARY_SUPPLEMENT

The supplements are delivered in plain vegetable 00 caps, stabelizing additives are potatostarch, sunflower lecithine and sunflower oil. The capsuels are free of titanium oxide and suited for human consumption.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (≥ 18 years)
• CKD G3b or G4 (44 - 15 ml/min/1.73 m2)
• Use of RAAS-I (ACE-inhibitor or angiotensin receptor blocker, ARB)

You may not qualify if:

• Use of any of the following drugs or supplements: mineralocorticoid receptor antagonists, potassium-sparing diuretics, oral potassium binders, immunosuppressive medication, tolvaptan, acetazolamide, topiramate, sodium bicarbonate.
• Patients using double RAAS blockade (i.e., ACE-inhibitor + ARB).
• Metabolic alkalosis (plasma bicarbonate \>27 mmol/L) at last outpatient visit
• Kidney transplant recipients
• Patients with an active gastro-intestinal ulcer
• Patients with previous history of ventricular cardiac arrhythmia
• Patients with a life expectancy \< 6 months
• Incapacitated subjects or subjects who are deemed unfit to adequately adhere to instructions from the research team
• Women who are pregnant, breastfeeding or consider pregnancy in the coming 7 weeks
• Patients with chronic respiratory acidosis in previous medical history
• Hyperkalemia (plasma potassium \>5.5 mmol/L) at V0

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

ErasmusMC

Rotterdam, South Holland, 3015 GD, Netherlands

Location

MeSH Terms

Conditions

Acidosis

Condition Hierarchy (Ancestors)

Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr. Ewout Hoorn

Model Details: Single-center, placebo-controlled double-blind randomized crossover study.

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: February 1, 2024
• Study Start: January 26, 2024
• Primary Completion: March 21, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)