Potassium-Containing Salt Substitute for Kidney Failure

Recruiting in Palo Alto (17 mi)

Overseen byDavid Charytan, MD MSc

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: NYU Langone Health

No Placebo Group

Trial Summary

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.

Eligibility Criteria

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.

+6 more

Participant Groups

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.

2Treatment groups

Experimental Treatment

Group I: Standard Table Salt, then Salt SubstituteExperimental Treatment2 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 SaltExperimental Treatment2 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.