Trial Outcomes & Findings for Potassium Intake-response Trial to Control Hypertension (NCT NCT05758142)
NCT ID: NCT05758142
Last Updated: 2026-05-13
Results Overview
Ambulatory blood pressure monitoring will be used to determine 24-hour systolic BP
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
25 participants
Primary outcome timeframe
12 weeks
Results posted on
2026-05-13
Participant Flow
Participant milestones
| Measure |
Placebo
Participants randomized to the placebo arm will receive 1, 2, or 3 inert placebo tablets twice daily (i.e., 2, 4, or 6 tablets per day) for 12 weeks.
|
Potassium Chloride 30 mmol Per Day
Participants randomized to the 30 mmol per day group will receive 1 potassium chloride tablet (15 mmol strength) twice daily (i.e., 2 tablets per day) for 12 weeks.
|
Potassium Chloride 60 mmol Per Day
Participants randomized to the 60 mmol per day group will receive 2 potassium chloride tablets (15 mmol strength) twice daily (i.e., 4 tablets per day) for 12 weeks.
|
Potassium Chloride 90 mmol Per Day
Participants randomized to the 90 mmol per day group will receive 3 potassium chloride tablets (15 mmol strength) twice daily (i.e., 6 tablets per day) for 12 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
6
|
7
|
5
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
7
|
6
|
7
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Potassium Intake-response Trial to Control Hypertension
Baseline characteristics by cohort
| Measure |
Placebo
n=7 Participants
Participants randomized to the placebo arm will receive 1, 2, or 3 inert placebo tablets twice daily (i.e., 2, 4, or 6 tablets per day) for 12 weeks.
|
Potassium Chloride 30 mmol Per Day
n=6 Participants
Participants randomized to the 30 mmol per day group will receive 1 potassium chloride tablet (15 mmol strength) twice daily (i.e., 2 tablets per day) for 12 weeks.
|
Potassium Chloride 60 mmol Per Day
n=7 Participants
Participants randomized to the 60 mmol per day group will receive 2 potassium chloride tablets (15 mmol strength) twice daily (i.e., 4 tablets per day) for 12 weeks.
|
Potassium Chloride 90 mmol Per Day
n=5 Participants
Participants randomized to the 90 mmol per day group will receive 3 potassium chloride tablets (15 mmol strength) twice daily (i.e., 6 tablets per day) for 12 weeks.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
0 Participants
n=99 Participants
|
0 Participants
n=97 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=1512 Participants
|
6 Participants
n=504 Participants
|
7 Participants
n=2016 Participants
|
5 Participants
n=99 Participants
|
25 Participants
n=97 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
0 Participants
n=99 Participants
|
0 Participants
n=97 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=1512 Participants
|
3 Participants
n=504 Participants
|
4 Participants
n=2016 Participants
|
2 Participants
n=99 Participants
|
12 Participants
n=97 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=1512 Participants
|
3 Participants
n=504 Participants
|
3 Participants
n=2016 Participants
|
3 Participants
n=99 Participants
|
13 Participants
n=97 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
0 Participants
n=99 Participants
|
0 Participants
n=97 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
0 Participants
n=99 Participants
|
0 Participants
n=97 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
0 Participants
n=99 Participants
|
0 Participants
n=97 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=1512 Participants
|
3 Participants
n=504 Participants
|
3 Participants
n=2016 Participants
|
2 Participants
n=99 Participants
|
11 Participants
n=97 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=1512 Participants
|
3 Participants
n=504 Participants
|
4 Participants
n=2016 Participants
|
3 Participants
n=99 Participants
|
14 Participants
n=97 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
0 Participants
n=99 Participants
|
0 Participants
n=97 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
0 Participants
n=99 Participants
|
0 Participants
n=97 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Study was terminated early. The IRB instructed us to delete all study data at the time of termination. As a result, no outcome data is available.
Ambulatory blood pressure monitoring will be used to determine 24-hour systolic BP
Outcome measures
| Measure |
Placebo
n=4 Participants
Participants randomized to the placebo arm will receive 1, 2, or 3 inert placebo tablets twice daily (i.e., 2, 4, or 6 tablets per day) for 12 weeks.
|
Potassium Chloride 30 mmol Per Day
n=1 Participants
Participants randomized to the 30 mmol per day group will receive 1 potassium chloride tablet (15 mmol strength) twice daily (i.e., 2 tablets per day) for 12 weeks.
|
Potassium Chloride 60 mmol Per Day
n=2 Participants
Participants randomized to the 60 mmol per day group will receive 2 potassium chloride tablets (15 mmol strength) twice daily (i.e., 4 tablets per day) for 12 weeks.
|
Potassium Chloride 90 mmol Per Day
n=2 Participants
Participants randomized to the 90 mmol per day group will receive 3 potassium chloride tablets (15 mmol strength) twice daily (i.e., 6 tablets per day) for 12 weeks.
|
|---|---|---|---|---|
|
Change in 24-hour Systolic Blood Pressure (BP) From Baseline to 12 Weeks
|
9.0 mm Hg
Interval -4.2 to 24.2
|
-11.0 mm Hg
Interval -11.0 to -11.0
|
1.8 mm Hg
Interval 1.0 to 2.5
|
16.2 mm Hg
Interval 10.3 to 22.0
|
SECONDARY outcome
Timeframe: 12 weeksAmbulatory blood pressure monitoring will be used to determine 24-hour diastolic BP
Outcome measures
| Measure |
Placebo
n=4 Participants
Participants randomized to the placebo arm will receive 1, 2, or 3 inert placebo tablets twice daily (i.e., 2, 4, or 6 tablets per day) for 12 weeks.
|
Potassium Chloride 30 mmol Per Day
n=1 Participants
Participants randomized to the 30 mmol per day group will receive 1 potassium chloride tablet (15 mmol strength) twice daily (i.e., 2 tablets per day) for 12 weeks.
|
Potassium Chloride 60 mmol Per Day
n=2 Participants
Participants randomized to the 60 mmol per day group will receive 2 potassium chloride tablets (15 mmol strength) twice daily (i.e., 4 tablets per day) for 12 weeks.
|
Potassium Chloride 90 mmol Per Day
n=2 Participants
Participants randomized to the 90 mmol per day group will receive 3 potassium chloride tablets (15 mmol strength) twice daily (i.e., 6 tablets per day) for 12 weeks.
|
|---|---|---|---|---|
|
Change in 24-hour Diastolic Blood Pressure (BP) From Baseline to 12 Weeks
|
4.5 mm Hg
Interval -3.4 to 10.4
|
-16.7 mm Hg
Interval -16.7 to -16.7
|
3.1 mm Hg
Interval -0.1 to 6.4
|
8.4 mm Hg
Interval -0.1 to 17.0
|
SECONDARY outcome
Timeframe: 12 weeksAmbulatory blood pressure monitoring will be used to determine daytime BP
Outcome measures
| Measure |
Placebo
n=4 Participants
Participants randomized to the placebo arm will receive 1, 2, or 3 inert placebo tablets twice daily (i.e., 2, 4, or 6 tablets per day) for 12 weeks.
|
Potassium Chloride 30 mmol Per Day
n=1 Participants
Participants randomized to the 30 mmol per day group will receive 1 potassium chloride tablet (15 mmol strength) twice daily (i.e., 2 tablets per day) for 12 weeks.
|
Potassium Chloride 60 mmol Per Day
n=2 Participants
Participants randomized to the 60 mmol per day group will receive 2 potassium chloride tablets (15 mmol strength) twice daily (i.e., 4 tablets per day) for 12 weeks.
|
Potassium Chloride 90 mmol Per Day
n=2 Participants
Participants randomized to the 90 mmol per day group will receive 3 potassium chloride tablets (15 mmol strength) twice daily (i.e., 6 tablets per day) for 12 weeks.
|
|---|---|---|---|---|
|
Change in Daytime (Awake) Systolic Blood Pressure (BP) From Baseline to 12 Weeks
|
4.9 mm Hg
Interval -3.5 to 18.7
|
-3.1 mm Hg
Interval -3.1 to -3.1
|
4.6 mm Hg
Interval -1.3 to 10.5
|
17.3 mm Hg
Interval 10.2 to 24.5
|
SECONDARY outcome
Timeframe: 12 weeksAmbulatory blood pressure monitoring will be used to determine daytime BP
Outcome measures
| Measure |
Placebo
n=4 Participants
Participants randomized to the placebo arm will receive 1, 2, or 3 inert placebo tablets twice daily (i.e., 2, 4, or 6 tablets per day) for 12 weeks.
|
Potassium Chloride 30 mmol Per Day
n=1 Participants
Participants randomized to the 30 mmol per day group will receive 1 potassium chloride tablet (15 mmol strength) twice daily (i.e., 2 tablets per day) for 12 weeks.
|
Potassium Chloride 60 mmol Per Day
n=2 Participants
Participants randomized to the 60 mmol per day group will receive 2 potassium chloride tablets (15 mmol strength) twice daily (i.e., 4 tablets per day) for 12 weeks.
|
Potassium Chloride 90 mmol Per Day
n=2 Participants
Participants randomized to the 90 mmol per day group will receive 3 potassium chloride tablets (15 mmol strength) twice daily (i.e., 6 tablets per day) for 12 weeks.
|
|---|---|---|---|---|
|
Change in Daytime (Awake) Diastolic Blood Pressure (BP) From Baseline to 12 Weeks
|
1.3 mm Hg
Interval -6.5 to 5.8
|
-10.3 mm Hg
Interval -10.3 to -10.3
|
5.8 mm Hg
Interval -2.9 to 14.6
|
9.6 mm Hg
Interval 0.8 to 18.4
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Only one person in the Potassium Chloride 30 mmol per day reached the end of the study. That participant did not have any night (11PM-7AM) ABPM measurements.
Ambulatory blood pressure monitoring will be used to determine nighttime BP
Outcome measures
| Measure |
Placebo
n=4 Participants
Participants randomized to the placebo arm will receive 1, 2, or 3 inert placebo tablets twice daily (i.e., 2, 4, or 6 tablets per day) for 12 weeks.
|
Potassium Chloride 30 mmol Per Day
Participants randomized to the 30 mmol per day group will receive 1 potassium chloride tablet (15 mmol strength) twice daily (i.e., 2 tablets per day) for 12 weeks.
|
Potassium Chloride 60 mmol Per Day
n=1 Participants
Participants randomized to the 60 mmol per day group will receive 2 potassium chloride tablets (15 mmol strength) twice daily (i.e., 4 tablets per day) for 12 weeks.
|
Potassium Chloride 90 mmol Per Day
n=2 Participants
Participants randomized to the 90 mmol per day group will receive 3 potassium chloride tablets (15 mmol strength) twice daily (i.e., 6 tablets per day) for 12 weeks.
|
|---|---|---|---|---|
|
Change in Nighttime (Asleep) Systolic Blood Pressure (BP) From Baseline to 12 Weeks
|
19.6 mm Hg
Interval -5.2 to 38.4
|
—
|
4.3 mm Hg
Interval 4.3 to 4.3
|
3.9 mm Hg
Interval -7.2 to 15.1
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Only 1 participants reached the end of the study in the Potassium Chloride 30 mmol per day arm. That participant did not collect any night (11PM-7AM) ABPM measurements.
Ambulatory blood pressure monitoring will be used to determine nighttime BP
Outcome measures
| Measure |
Placebo
n=4 Participants
Participants randomized to the placebo arm will receive 1, 2, or 3 inert placebo tablets twice daily (i.e., 2, 4, or 6 tablets per day) for 12 weeks.
|
Potassium Chloride 30 mmol Per Day
Participants randomized to the 30 mmol per day group will receive 1 potassium chloride tablet (15 mmol strength) twice daily (i.e., 2 tablets per day) for 12 weeks.
|
Potassium Chloride 60 mmol Per Day
n=1 Participants
Participants randomized to the 60 mmol per day group will receive 2 potassium chloride tablets (15 mmol strength) twice daily (i.e., 4 tablets per day) for 12 weeks.
|
Potassium Chloride 90 mmol Per Day
n=2 Participants
Participants randomized to the 90 mmol per day group will receive 3 potassium chloride tablets (15 mmol strength) twice daily (i.e., 6 tablets per day) for 12 weeks.
|
|---|---|---|---|---|
|
Change in Nighttime (Asleep) Diastolic Blood Pressure (BP) From Baseline to 12 Weeks
|
12.4 mm Hg
Interval -0.4 to 26.3
|
—
|
0.2 mm Hg
Interval 0.2 to 0.2
|
3.9 mm Hg
Interval -7.2 to 15.1
|
SECONDARY outcome
Timeframe: 12 weeksAn automated oscillometric device will be used to determine office BP based on the mean of 6 blood pressure values from two 12-week visits minus the mean of 6 values from 2 baseline visits
Outcome measures
| Measure |
Placebo
n=4 Participants
Participants randomized to the placebo arm will receive 1, 2, or 3 inert placebo tablets twice daily (i.e., 2, 4, or 6 tablets per day) for 12 weeks.
|
Potassium Chloride 30 mmol Per Day
n=1 Participants
Participants randomized to the 30 mmol per day group will receive 1 potassium chloride tablet (15 mmol strength) twice daily (i.e., 2 tablets per day) for 12 weeks.
|
Potassium Chloride 60 mmol Per Day
n=2 Participants
Participants randomized to the 60 mmol per day group will receive 2 potassium chloride tablets (15 mmol strength) twice daily (i.e., 4 tablets per day) for 12 weeks.
|
Potassium Chloride 90 mmol Per Day
n=2 Participants
Participants randomized to the 90 mmol per day group will receive 3 potassium chloride tablets (15 mmol strength) twice daily (i.e., 6 tablets per day) for 12 weeks.
|
|---|---|---|---|---|
|
Change in Office Systolic Blood Pressure (BP) From Baseline to 12 Weeks
|
-2 mm Hg
Interval -8.0 to 7.0
|
1 mm Hg
Interval 1.0 to 1.0
|
3.5 mm Hg
Interval 3.0 to 4.0
|
-8.5 mm Hg
Interval -18.0 to 1.0
|
SECONDARY outcome
Timeframe: 12 weeksAn automated oscillometric device will be used to determine office BP based on the mean of 6 blood pressure values from two 12-week visits minus the mean of 6 values from 2 baseline visits
Outcome measures
| Measure |
Placebo
n=4 Participants
Participants randomized to the placebo arm will receive 1, 2, or 3 inert placebo tablets twice daily (i.e., 2, 4, or 6 tablets per day) for 12 weeks.
|
Potassium Chloride 30 mmol Per Day
n=1 Participants
Participants randomized to the 30 mmol per day group will receive 1 potassium chloride tablet (15 mmol strength) twice daily (i.e., 2 tablets per day) for 12 weeks.
|
Potassium Chloride 60 mmol Per Day
n=2 Participants
Participants randomized to the 60 mmol per day group will receive 2 potassium chloride tablets (15 mmol strength) twice daily (i.e., 4 tablets per day) for 12 weeks.
|
Potassium Chloride 90 mmol Per Day
n=2 Participants
Participants randomized to the 90 mmol per day group will receive 3 potassium chloride tablets (15 mmol strength) twice daily (i.e., 6 tablets per day) for 12 weeks.
|
|---|---|---|---|---|
|
Change in Office Diastolic Blood Pressure (BP) From Baseline to 12 Weeks
|
-7.75 mm Hg
Interval -13.0 to -1.0
|
2 mm Hg
Interval 2.0 to 2.0
|
5.5 mm Hg
Interval 3.0 to 8.0
|
-5.5 mm Hg
Interval -9.0 to -2.0
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Potassium Chloride 30 mmol Per Day
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Potassium Chloride 60 mmol Per Day
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Potassium Chloride 90 mmol Per Day
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place