About 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 does not accept healthy volunteersQualifiers
Receiving outpatient maintenance HD therapy.
Age ≥ 21 years.
Negative serum pregnancy test for women of child-bearing capacity. Childbearing capacity will be defined by report of menstruation within ≤ 6 months.
Disqualifiers
Currently incarcerated.
Insufficient capacity for informed consent.
Non-hemolyzed serum potassium concentration >6.0 mEq/L within ≤30 days.
Unscheduled HD for hyperkalemia within ≤30 days.
Trial design
Crossover
Treatments tested in this trial
Standard Table Salt
Dietary supplementStandard 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
Dietary supplementSalt 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.
Treatment groups
Trial outcomes
Primary outcomes
Change in Serum Potassium Concentration During First Treatment Period
Serum potassium concentration expressed in milliequivalents per liter (mEq/L).
Change in Serum Potassium Concentration During Second Treatment Period
Serum potassium concentration expressed in mEq/L.
Secondary outcomes
Number of Participants Presenting with Severe Hyperkalemia During First Treatment Period
Severe hyperkalemia defined as pre-dialysis potassium levels greater than 6.5 mEq/L. The first treatment period spans from Day 1 to Day 16.
Number of Participants Presenting with Severe Hyperkalemia During Second Treatment Period
Severe hyperkalemia defined as pre-dialysis potassium levels greater than 6.5 mEq/L. The second treatment period spans from Day 36 to Day 52.
Number of Participants Presenting with Moderate Hyperkalemia
Moderate hyperkalemia defined as pre-dialysis potassium levels greater than 6.0 mEq/L and less than 6.5 mEq/L.
Mean Potassium Concentration During First Treatment Period
Potassium concentration expressed in mEq/L. The first treatment period spans from Day 1 to Day 16.
Sponsors and contacts
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