A Randomized, Pilot, Double-Blind Crossover Trial of a Potassium Containing Salt-Substitute in Hemodialysis-Dependent End Stage Kidney Disease
NYU Langone Health
Summary
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
- Age range
- 21+ years
- Sex
- All
- Healthy volunteers
- No
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 w…
Interventions
- Dietary SupplementStandard 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.
- Dietary SupplementSalt 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.
Location
- NYU Langone HealthNew York, New York