Trial Outcomes & Findings for Value of Liquid Potassium Magnesium Citrate in Controlling Hypertension (NCT NCT02653560)
NCT ID: NCT02653560
Last Updated: 2023-10-16
Results Overview
Systolic blood pressure was measured through an ambulatory blood pressure monitoring device worn by each participant for 24 hours after completing each treatment phase. This devise measures blood pressure intermittently throughout the day and night and provides the average of all readings.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
30 participants
Primary outcome timeframe
4 weeks
Results posted on
2023-10-16
Participant Flow
Participant milestones
| Measure |
Potassium Magnesium Citrate (KMgCit) Arm
Potassium magnesium citrate will be prepared by mixing potassium citrate, magnesium citrate and/or citric acid by Meta Pharm Development. The content of each sachet will be dissolved in 250 ml water and will be drunk with breakfast and again with dinner during the KMgCit Phase, to deliver 40 meq K, 20 meq Mg and 74 meq citrate per day for 4 weeks
Potassium magnesium Citrate (KMgCit)
|
Potassium Citrate Arm
A special sachet formulation containing 20 meq K/sachet will be made for the study by Meta Pharm Development. The contents of a sachet will be added to 250 ml water and drunk with breakfast and dinner, to deliver 40 meq K (as citrate) per day during the Potassium Citrate Phase for 4 weeks.
Potassium citrate powder
|
Potassium Chloride Arm
Potassium chloride will contain 20 meq KCl per sachet. During the Potassium Chloride Phase, subjects will dissolve the content of each sachet in 250 ml water and ingest it with breakfast and again with dinner, to deliver 40 meq K (as chloride) per day for 4 weeks
Potassium chloride powder
|
Placebo
Placebo will comprise microcrystalline cellulose, equivalent in volume in each sachet as other test products. During the Placebo Phase, subjects will dissolve the entire content of a sachet in 250 ml water and drink it with breakfast and again with dinner for 4 weeks.
Placebo
|
|---|---|---|---|---|
|
KMgCit Phase
STARTED
|
30
|
0
|
0
|
0
|
|
KMgCit Phase
COMPLETED
|
30
|
0
|
0
|
0
|
|
KMgCit Phase
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
K Citrate Phase
STARTED
|
0
|
30
|
0
|
0
|
|
K Citrate Phase
COMPLETED
|
0
|
30
|
0
|
0
|
|
K Citrate Phase
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
KCl Phase
STARTED
|
0
|
0
|
30
|
0
|
|
KCl Phase
COMPLETED
|
0
|
0
|
30
|
0
|
|
KCl Phase
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Placebo Phase
STARTED
|
0
|
0
|
0
|
30
|
|
Placebo Phase
COMPLETED
|
0
|
0
|
0
|
30
|
|
Placebo Phase
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Value of Liquid Potassium Magnesium Citrate in Controlling Hypertension
Baseline characteristics by cohort
| Measure |
All Study Participants
n=30 Participants
Participants took Potassium magnesium Citrate (KMgCit), potassium citrate (KCit), potassium chloride (KCl) and placebo each for 4 weeks in a randomized crossover design.
|
|---|---|
|
Age, Continuous
|
54 years
STANDARD_DEVIATION 12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeksSystolic blood pressure was measured through an ambulatory blood pressure monitoring device worn by each participant for 24 hours after completing each treatment phase. This devise measures blood pressure intermittently throughout the day and night and provides the average of all readings.
Outcome measures
| Measure |
Potassium Magnesium Citrate (KMgCit) Arm
n=30 Participants
Potassium magnesium citrate will be prepared by mixing potassium citrate, magnesium citrate and/or citric acid by Meta Pharm Development. The content of each sachet will be dissolved in 250 ml water and will be drunk with breakfast and again with dinner during the KMgCit Phase, to deliver 40 meq K, 20 meq Mg and 74 meq citrate per day for 4 weeks
Potassium magnesium Citrate (KMgCit)
|
Potassium Citrate Arm
n=30 Participants
A special sachet formulation containing 20 meq K/sachet will be made for the study by Meta Pharm Development. The contents of a sachet will be added to 250 ml water and drunk with breakfast and dinner, to deliver 40 meq K (as citrate) per day during the Potassium Citrate Phase for 4 weeks.
Potassium citrate powder
|
Potassium Chloride Arm
n=30 Participants
Potassium chloride will contain 20 meq KCl per sachet. During the Potassium Chloride Phase, subjects will dissolve the content of each sachet in 250 ml water and ingest it with breakfast and again with dinner, to deliver 40 meq K (as chloride) per day for 4 weeks
Potassium chloride powder
|
Placebo
n=30 Participants
Placebo will comprise microcrystalline cellulose, equivalent in volume in each sachet as other test products. During the Placebo Phase, subjects will dissolve the entire content of a sachet in 250 ml water and drink it with breakfast and again with dinner for 4 weeks.
Placebo
|
|---|---|---|---|---|
|
24-hour Average Systolic Blood Pressure
|
127 mmHg
Standard Deviation 11
|
127 mmHg
Standard Deviation 10
|
126 mmHg
Standard Deviation 9
|
129 mmHg
Standard Deviation 13
|
Adverse Events
Potassium Magnesium Citrate (KMgCit) Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Potassium Citrate Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Potassium Chloride Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
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