Potassium Containing Salt-Substitute in Hemodialysis-Dependent End Stage Kidney Disease

NYU Langone Health

Status: Not yet enrolling

Conditions: End Stage Kidney Disease

Treatments: Dietary Supplement: Standard Table Salt; Dietary Supplement: Salt Substitute

Study type: Interventional

Funder types: Other

Identifiers

NCT05558267

22-00769

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Receiving outpatient maintenance HD therapy.
2. Age ≥ 21 years.
3. Negative serum pregnancy test for women of child-bearing capacity. Childbearing capacity will be defined by report of menstruation within ≤ 6 months.

Exclusion criteria

1. Currently incarcerated.
2. Insufficient capacity for informed consent.
3. Non-hemolyzed serum potassium concentration >6.0 mEq/L within ≤30 days.
4. Unscheduled HD for hyperkalemia within ≤30 days.
5. Attendance at ≤10 of last 13 scheduled OP HD sessions.
6. Co-habiting family member with known hyperkalemia.
7. Co-habiting family with ≥stage 3b chronic kidney disease or chronic kidney disease of unknown severity.
8. Hemoglobin < 8.0 mg/dL.
9. Use of other potassium supplements.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 2 patient groups

Standard Table Salt, then Salt Substitute

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Salt Substitute

Dietary Supplement: Standard Table Salt

Salt Substitute, then Standard Table Salt

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Salt Substitute

Dietary Supplement: Standard Table Salt