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NCT07178964Not yet recruiting

POTASSIUM-RICH SALT SUBSTITUTES IN KIDNEY TRANSPLANT RECIPIENTS

THE USE OF POTASSIUM-RICH SALT SUBSTITUTES IN BLOOD PRESSURE CONTROL OF KIDNEY TRANSPLANT RECIPIENTS

Source: ClinicalTrials.gov · Last updated 17 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
80 (estimated)
First submitted
10 Sept 2025
Start date
1 Oct 2025
Primary completion date
30 Jun 2026
Lead sponsor
University Medical Centre Ljubljana
NCT number
NCT07178964

What you commit to

  • Study type: Interventional
  • Planned participants: 80
  • From 1 Oct 2025 to the primary completion date, 30 Jun 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • multiple organ transplantation

Other illness

  • history of unexplained hyperkalemia
  • inability to provide informed consent or to participate in the study (mental retardation, psychiatric illness in an uncontrolled phase)

Lab values

  • eGFR according to CKD/EPI equation below 25 ml/min
  • serum potassium \> 5 mmol/l

Other

  • pregnancy or planning of pregnancy
  • Consuming most of daily meals outside the home environment

Who the study is looking for

  • patients with a transplanted kidney ≥ 3 months post kidney-transplant
  • a functioning transplanted kidney with estimated glomerular filtration rate (eGFR) according to CKD/EPI equation of at least 25 ml/min
  • Elevated blood pressure/hypertension at the time of examination at the Kidney Transplantation Center outpatient clinic, determined by standardized blood pressure measurement (RR ≥ 130/80 mmHg)
  • Age ≥ 18 years

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University Medical Centre Ljubljana
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LjubljanaSloveniaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.