POTASSIUM-RICH SALT SUBSTITUTES IN KIDNEY TRANSPLANT RECIPIENTS

Summary

Excessive sodium intake and inadequate potassium intake in the diet are known risk factors for the development of arterial hypertension and an increased risk of cardiovascular events. Data from randomized controlled trials show that the use of salt substitutes with reduced sodium and increased potassium content represent an effective way to reduce dietary sodium intake, blood pressure and the occurrence of cardiovascular events. Patients adhere well to the use of salt substitutes as they do not have to change their daily cooking and seasoning habits and the taste is comparable to that of regular salt. The World Health Organization (WHO) also suggests the use of salt substitutes as an acceptable strategy for reducing dietary salt intake and thus lowering blood pressure and the burden of cardiovascular disease. Recommendations for the use of salt substitutes are not uniform, primarily because of the potential risk of adverse events with increased potassium intake in some individuals, such as patients with advanced chronic kidney disease (CKD), patients receiving potassium-sparing diuretics, and patients receiving potassium supplements.

Nephrology guidelines rarely comment on the use of potassium-rich salt substitutes or discourage their use in patients with advanced stage 4 and 5 CKD, with the exception of Chinese guidelines, which mention the use of potassium-rich salt substitutes in CKD patients not on dialysis depending on serum potassium levels. CKD patients have largely been excluded from clinical trials of potassium-rich salt substitutes, so there is insufficient data on their safety and efficacy in CKD patients.

In this randomized controlled trial, we will investigate the effects of using potassium-enriched salt substitutes on blood pressure control and serum potassium levels in kidney transplant recipients. In the intervention group, patients will use potassium-enriched salt substitutes at home in a ratio of 75% sodium chloride and 25% potassium chloride instead of regular table salt (100% sodium chloride) for cooking and seasoning food. In the control group, patients will use regular salt at home for cooking and seasoning food. The intervention and control groups will each include 40 to 50 patients who will be monitored for 12 weeks. The study's main focus will be the change in serum potassium and blood pressure before and after the intervention.

We expect to confirm the positive effects of potassium-enriched salt substitutes on blood pressure in kidney transplant recipients without causing undesirable hyperkalemia.

Conditions

• Hypertension Arterial
• Kidney Transplant

Interventions

OTHER

Potassium-enriched salt-substitute

The patients in the experimental group will use potassium-enriched salt-substitutes for cooking and seasoning food in their home environment. Potassium-enriched salt-substitutes will contain 25% potassium chloride nad 75% sodium chloride.

OTHER

Regular table salt

Patients in this arm will use regular table salt (100 % sodium chloride) for cooking and seasoning food in their home environment.

Sponsors & Collaborators

• University Medical Centre Ljubljana

  lead OTHER

Principal Investigators

• Tanja Belcic Mikic, MD, PhD, FEBTM · University Medical Centre Ljubljana

• Miha Arnol, Professor, MD, PhD, FEBTM · University Medical Centre Ljubljana

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-10-01

Primary Completion

2026-06-30

Completion

2026-09-30

Countries

• Slovenia

Study Locations