Potassium-Containing Salt Substitute for Kidney Failure

Overseen By Zoe Rimler

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Must not be taking: Potassium supplements

Disqualifiers: Incarceration, Hyperkalemia, Anemia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

16 individuals with hemodialysis-dependent end stage kidney disease will receive 16 days of a potassium-containing salt-substitute and 16 days of standard table salt in random order. There will be a 19 day wash out period between the salt-substitute and table salt periods. Potassium concentration will be measured bi-weekly prior to HD each week during intervention. The primary endpoint will be the change in potassium from baseline. Additional measurements will include assessment of dietary intake, ambulatory blood pressure, occurrence of peri-dialytic symptoms, and per-dialytic vital signs.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot use other potassium supplements while participating.

Is the potassium-containing salt substitute safe for humans?

Potassium-containing salt substitutes are generally safe for most people, but they can cause high potassium levels (hyperkalemia) in those with certain health conditions like kidney problems or heart failure. It's important to monitor potassium levels and consult a doctor if you have any health issues before using these substitutes. ^{1 2 3 4 5}

How does the potassium-containing salt substitute treatment differ from other treatments for kidney failure?

The potassium-containing salt substitute is unique because it replaces regular salt with a potassium-enriched version, which can help manage blood pressure and reduce cardiovascular risks. However, it may pose a risk of hyperkalemia (high potassium levels in the blood) in individuals with kidney failure, unlike other treatments that do not involve altering dietary salt. ^{1 3 6 7 8}

What data supports the effectiveness of the treatment Potassium Containing Salt-Substitute for kidney failure?

Research shows that potassium-enriched salt substitutes can lower blood pressure by reducing sodium intake and increasing potassium intake, which may help prevent heart-related issues. However, there is a concern about the risk of high potassium levels, especially in people with kidney problems. ^{1 3 9 10 11}

Who Is on the Research Team?

David Charytan, MD MSc

Principal Investigator

NYU Langone Medical Center

Are You a Good Fit for This Trial?

This trial is for adults over 21 with end-stage kidney disease who are on outpatient hemodialysis. They must not be pregnant, incarcerated, unable to consent, have high potassium levels or missed too many dialysis sessions recently. People living with someone who has severe kidney issues or uses potassium supplements can't join.

Inclusion Criteria

I am 21 years old or older.

Women who can have children must have a negative pregnancy test and have had a period within the last 6 months.

I am currently on outpatient hemodialysis.

Exclusion Criteria

Currently incarcerated.

I am unable to understand and give informed consent.

A family member I live with has advanced chronic kidney disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

First Treatment Period

Participants receive either the Salt Substitute or Standard Table Salt for 16 days

16 days

Bi-weekly visits for potassium measurement

Washout Period

Participants undergo a washout period between treatment phases

19 days

Second Treatment Period

Participants receive the alternate treatment (Salt Substitute or Standard Table Salt) for 16 days

16 days

Bi-weekly visits for potassium measurement

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Potassium Containing Salt-Substitute

Trial Overview The study tests a potassium-containing salt substitute versus standard table salt in patients undergoing hemodialysis. Each participant will try both salts for 16 days each, separated by a 19-day break. The main focus is how the different salts affect blood potassium levels.

How Is the Trial Designed?

Group I: Standard Table Salt, then Salt Substitute Experimental Treatment 2 Interventions

The two intervention periods will last 16 days with a 19-day washout period in between. During the first 16-day treatment period, participants will receive the Standard Table Salt to use for cooking and as an additive at the table. Participants will then undergo a 19-day washout period. The second 16-day treatment period will immediately follow the washout period. During the second 16-day treatment period, participants will receive the Salt Substitute to use for cooking and as an additive at the table. Participants will be encouraged to replace their use of regular salt with the Standard Table Salt and Salt Substitute. They will be encouraged to reduce their overall intake of salt throughout the study period. There are no restrictions or further instructions regarding timing or dosing. In addition, participants will undergo standard of care hemodialysis (typically 3x/week) and have their blood chemistries measured according to the usual standard of care during the study.

Group II: Salt Substitute, then Standard Table Salt Experimental Treatment 2 Interventions

The two intervention periods will last 16 days with a 19-day washout period in between. During the first 16-day treatment period, participants will receive the Salt Substitute to use for cooking and as an additive at the table. Participants will then undergo a 19-day washout period. The second 16-day treatment period will immediately follow the washout period. During the second 16-day treatment period, participants will receive the Standard Table Salt to use for cooking and as an additive at the table. Participants will be encouraged to replace their use of regular salt with the Standard Table Salt and Salt Substitute. They will be encouraged to reduce their overall intake of salt throughout the study period. There are no restrictions or further instructions regarding timing or dosing. In addition, participants will undergo standard of care hemodialysis (typically 3x/week) and have their blood chemistries measured according to the usual standard of care during the study.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Published Research Related to This Trial

Potassium-enriched salt substitutes can significantly lower blood pressure, with average reductions of -5.58 mm Hg for systolic and -2.88 mm Hg for diastolic pressure, making them a promising strategy for reducing sodium intake and improving heart health.

However, there is a risk of hyperkalemia, which can lead to serious heart issues, particularly in individuals with kidney problems, highlighting the need for more research on the safety and population-wide effects of these substitutes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potassium-Enriched Salt Substitutes as a Means to Lower Blood Pressure: Benefits and Risks. Greer, RC., Marklund, M., Anderson, CAM., et al.[2020]

A study involving 10 patients with controlled hypertension showed that a salt substitute effectively maintained normal serum potassium levels over a 6-week period, demonstrating its efficacy as a potassium replacement.

Despite being safe and cost-effective, patient acceptance of the salt substitute was low, with 8 out of 10 participants preferring to return to their prescription potassium product, indicating a challenge in its adoption despite its benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of salt substitutes in the treatment of diuretic-induced hypokalemia. Hueston, WJ.[2014]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Potassium-Enriched Salt Substitutes as a Means to Lower Blood Pressure: Benefits and Risks. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Estimated Benefits and Risks of Using a Reduced-Sodium, Potassium-Enriched Salt Substitute in India: A Modeling Study. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Use of salt substitutes in the treatment of diuretic-induced hypokalemia. [2014]

4. England pubmed.ncbi.nlm.nih.gov

Challenges in Treating Cardiovascular Disease: Restricting Sodium and Managing Hyperkalemia. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Low-sodium, high-potassium diet: feasibility and acceptability in a normotensive population. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Hyperkalemia with cardiac arrhythmia. Induction by salt substitutes, spironolactone, and azotemia. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Life-threatening hyperkalemia in a patient with normal renal function. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Salt substitutes and medicinal potassium sources: risks and benefits. [2013]

9. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[The effect of the table salt substitute sanasol on arterial pressure, water-salt metabolism and kidney functions in experimental pathology of circulatory homeostasis]. [2013]

10. United States pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Patiromer in Hyperkalemic Patients with CKD: A Pooled Analysis of Three Randomized Trials. [2023]

11. England pubmed.ncbi.nlm.nih.gov

Severe hyperkalaemia due to the concomitant use of salt substitutes and ACE inhibitors in hypertension: a potentially life threatening interaction. [2019]