Potassium Containing Salt-Substitute in Hemodialysis-Dependent End Stage Kidney Disease
NCT ID: NCT05558267
Last Updated: 2025-04-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
20 participants
INTERVENTIONAL
2025-08-15
2026-03-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
DOUBLE
Study Groups
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Standard Table Salt, then Salt Substitute
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.
Standard Table Salt
Standard Table Salt is administered orally. It is transferred to unmarked saltshakers by non-blinded research coordinators. The unmarked saltshaker is delivered to the participant during dialysis.
Salt Substitute
Salt Substitute is available as a crystalized powder. It substitutes potassium chloride for sodium chloride, and thus contains about 50% less sodium than standard table salt.
Salt Substitute is administered orally. It is transferred to unmarked saltshakers by non-blinded research coordinators. The unmarked saltshaker is delivered to the participant during dialysis.
Salt Substitute, then Standard Table Salt
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.
Standard Table Salt
Standard Table Salt is administered orally. It is transferred to unmarked saltshakers by non-blinded research coordinators. The unmarked saltshaker is delivered to the participant during dialysis.
Salt Substitute
Salt Substitute is available as a crystalized powder. It substitutes potassium chloride for sodium chloride, and thus contains about 50% less sodium than standard table salt.
Salt Substitute is administered orally. It is transferred to unmarked saltshakers by non-blinded research coordinators. The unmarked saltshaker is delivered to the participant during dialysis.
Interventions
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Standard Table Salt
Standard Table Salt is administered orally. It is transferred to unmarked saltshakers by non-blinded research coordinators. The unmarked saltshaker is delivered to the participant during dialysis.
Salt Substitute
Salt Substitute is available as a crystalized powder. It substitutes potassium chloride for sodium chloride, and thus contains about 50% less sodium than standard table salt.
Salt Substitute is administered orally. It is transferred to unmarked saltshakers by non-blinded research coordinators. The unmarked saltshaker is delivered to the participant during dialysis.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
21 Years
ALL
No
Sponsors
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NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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David Charytan, MD MSc
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Medical Center
Locations
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NYU Langone Health
New York, New York, United States
Countries
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Central Contacts
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Other Identifiers
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22-00769
Identifier Type: -
Identifier Source: org_study_id
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