A Randomized, Pilot, Double-Blind Crossover Trial of a Potassium Containing Salt-Substitute in Hemodialysis-Dependent End Stage Kidney Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Serum Potassium Concentration During First Treatment Period
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
- •Attendance at ≤10 of last 13 scheduled OP HD sessions.
- •Co-habiting family member with known hyperkalemia.
- •Co-habiting family with ≥stage 3b chronic kidney disease or chronic kidney disease of unknown severity.
- •Hemoglobin < 8.0 mg/dL.
- •Use of other potassium supplements.
研究组 & 干预措施
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.
干预措施: Standard Table Salt (Dietary Supplement)
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.
干预措施: Salt Substitute (Dietary Supplement)
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.
干预措施: Standard Table Salt (Dietary Supplement)
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.
干预措施: Salt Substitute (Dietary Supplement)
结局指标
主要结局
Change in Serum Potassium Concentration During First Treatment Period
时间窗: Day 1, Day 16
Serum potassium concentration expressed in milliequivalents per liter (mEq/L).
Change in Serum Potassium Concentration During Second Treatment Period
时间窗: Day 36, Day 52
Serum potassium concentration expressed in mEq/L.
次要结局
- Number of Participants Presenting with Severe Hyperkalemia During First Treatment Period(Up to Day 16)
- Change in Ambulatory Systolic Blood Pressure During First Treatment Period(Day 1, Day 16)
- Mean Potassium Concentration During First Treatment Period(Up to Day 16)
- Mean Potassium Concentration During Second Treatment Period(From Day 36 up to Day 52)
- Number of Participants Presenting with Severe Hyperkalemia During Second Treatment Period(From Day 36 up to Day 52)
- Change in Ambulatory Systolic Blood Pressure During Second Treatment Period(Day 36, Day 52)
- Mean Pre-Dialysis Systolic Blood Pressure During First Treatment Period(Up to Day 16)
- Number of Participants Presenting with Moderate Hyperkalemia(Up to Day 52)
- Mean Pre-Dialysis Systolic Blood Pressure During Second Treatment Period(From Day 36 up to Day 52.)
- Number of Participants Presenting with Intradialytic Hypotension(Up to Day 52)