Hypertension
Conditions
Keywords
Potassium, Magnesium, Citrate, DASH
Brief summary
In the DASH (Dietary Approaches to Stop Hypertension) trials, a diet rich in fruits, vegetables, nuts and dairy products, and limited in fat content, was shown to be useful in controlling hypertension. Key components of such a diet are potassium, magnesium and alkali, each of which has been implicated in lowering blood pressure. Whether a liquid formulation of potassium-magnesium citrate will result in equivalent BP effect as the DASH diet is unknown.
Detailed description
The DASH diet is rich in potassium and magnesium. It is also high in alkali content, since the anions are provided mostly by citrate rather than chloride. Considerable data are already available in the literature invoking a protective role on hypertension of potassium, magnesium and alkali. In this protocol, the investigators want to test the hypothesis that liquid potassium-magnesium citrate (KMgCit) as a pharmaceutical formulation could serve as a surrogate for the DASH diet, and would lower blood pressure among patients with pre- or Stage I hypertension on their customary diet. Each subject will participate in all four phases, chosen in random order. The four phases will be: Placebo Phase (microcrystalline cellulose in water), Potassium Chloride Phase (potassium chloride powder in water), Potassium Citrate Phase (potassium citrate powder in water), KMgCit Phase (KMgCit powder in water) During each phase, subjects will receive one of the test drugs for 4 weeks, followed by at least 1 week of withdrawal. Change in 24 hr BP, office BP will be measured at baseline and after each phase. Central aortic blood pressure and carotid-femoral pulse wave velocity, -terminal-telopeptide (CTX), 24 hr urine electrolytes will be measured at 4 weeks in each phase.
Interventions
DRUGPlacebo
Sponsors
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with pre- or Stage I hypertension, with systolic blood pressure of 120-159 mm and diastolic of 80-99 mm * Age \> 21 years of age
Exclusion criteria
* Diabetes mellitus, * Renal impairment (serum creatinine \> 1.4 mg/dL), * Any heart diseases such as congestive heart failure or sustained arrhythmia, * Chronic NSAID use, * Treatment with diuretics, * Gastroesophageal reflux disease (GERD) requiring treatment with acid reducing agents or antacid more than once a week, * Esophageal-gastric ulcer, * Chronic diarrhea * Hyperkalemia (serum \> 4.6 mmol/L for patients on Angiotensin converting enzyme (ACE) inhibitors or Angiotensin receptor blockers (ARB), serum K \> 5.0 for patient not on ACE inhibitors or ARBs) * Liver function test above upper limit of normal range. * Subjects who require any potassium supplement on a regular basis from any reasons * Pregnancy * History of major depression, bipolar disorder, or schizophrenia * History of substance abuse.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 24-hour Average Systolic Blood Pressure | 4 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants Participants took Potassium magnesium Citrate (KMgCit), potassium citrate (KCit), potassium chloride (KCl) and placebo each for 4 weeks in a randomized crossover design. | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Continuous | 54 years STANDARD_DEVIATION 12 |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 |
Outcome results
Primary
24-hour Average Systolic Blood Pressure
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.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Potassium Magnesium Citrate (KMgCit) Arm | 24-hour Average Systolic Blood Pressure | 127 mmHg | Standard Deviation 11 |
| Potassium Citrate Arm | 24-hour Average Systolic Blood Pressure | 127 mmHg | Standard Deviation 10 |
| Potassium Chloride Arm | 24-hour Average Systolic Blood Pressure | 126 mmHg | Standard Deviation 9 |
| Placebo | 24-hour Average Systolic Blood Pressure | 129 mmHg | Standard Deviation 13 |