Potassium-Containing Salt Substitute for Kidney Failure

DC
ZR
Overseen ByZoe Rimler
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effects of a potassium-containing salt substitute on individuals with end-stage kidney disease undergoing hemodialysis. The researchers aim to determine if this substitute can safely alter blood potassium levels compared to regular table salt. Participants will use the salt substitute for 16 days and regular salt for another 16 days, with a break in between. This trial suits individuals who regularly attend outpatient hemodialysis sessions and do not currently have high potassium levels. As an unphased trial, it offers participants the chance to contribute to important research that could enhance dietary options for those on hemodialysis.

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.

What prior data suggests that this potassium-containing salt substitute is safe for individuals with kidney failure?

Research has shown that salt substitutes with potassium can be risky, especially for people with kidney problems. One study found that these substitutes might lead to hyperkalemia, which means having too much potassium in the blood. This condition can be serious and even life-threatening for some individuals. Another source suggests that the potassium amount in these substitutes is usually small and might not pose a danger to everyone, including those with kidney disease. However, the risk can vary based on individual health conditions. Regularly checking potassium levels when using these substitutes is important, as routine tests can help ensure safety.12345

Why are researchers excited about this trial?

Researchers are excited about these treatments because they explore a potentially safer alternative to traditional salt for people with kidney failure. Most treatments focus on managing symptoms and complications through medication and dietary restrictions. This trial investigates a potassium-containing salt substitute that could help reduce sodium intake without compromising flavor, which is crucial for managing blood pressure and fluid balance in kidney patients. By potentially offering a safer seasoning option, this treatment could enhance dietary management for kidney failure patients, potentially leading to better health outcomes.

What evidence suggests that this potassium-containing salt substitute might be an effective treatment for kidney failure?

Research has shown that salt substitutes with potassium can lower blood pressure by replacing some sodium in regular salt with potassium. However, individuals with chronic kidney disease (CKD) should exercise caution, as these substitutes might cause hyperkalaemia, a condition where too much potassium accumulates in the blood, posing risks for those with kidney issues. This trial will compare the effects of a Potassium-Containing Salt Substitute with Standard Table Salt in participants with kidney failure. Participants will receive both treatments in separate periods to evaluate their impact. For most people without CKD, the benefits of these substitutes may outweigh the risks. Consulting a healthcare provider before using them is important, especially for those with kidney problems.12346

Who Is on the Research Team?

DC

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.
See 6 more

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?
2Treatment groups
Experimental Treatment
Group I: Standard Table Salt, then Salt SubstituteExperimental Treatment2 Interventions
Group II: Salt Substitute, then Standard Table SaltExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials
1,431
Recruited
838,000+

Published Research Related to This Trial

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.
Use of salt substitutes in the treatment of diuretic-induced hypokalemia.Hueston, WJ.[2014]
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.
Potassium-Enriched Salt Substitutes as a Means to Lower Blood Pressure: Benefits and Risks.Greer, RC., Marklund, M., Anderson, CAM., et al.[2020]

Citations

Potassium-Enriched Salt Substitutes: A Review of ...Three guidelines warned that salt substitutes rich in potassium are not recommended for patients with CKD, while the fourth, the Chinese ...
Potassium-enriched salt substitutes: supporting global ...In this Comment, we discuss why the benefits of potassium-enriched salt substitutes could outweigh the risks for most individuals with CKD, propose next steps ...
Danger of salt substitutes that contain potassium in patients ...Salt substitutes that contain potassium may cause hyperkalaemia with life threatening consequences in susceptible patients.
Effect of Salt Substitution on Cardiovascular Events and ...Salt substitutes with reduced sodium levels and increased potassium levels have been shown to lower blood pressure, but their effects on cardiovascular and ...
Cost-effectiveness analysis of low-sodium potassium-rich ...The results show that sizeable cardiovascular and renal disease events could be averted, generating substantial savings in related healthcare ...
Are Salt Alternatives Dangerous for People With Kidney ...“The amount of potassium that could be used as a salt substitute is relatively small and not necessarily dangerous even to people with kidney ...
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