Value of Liquid Potassium Magnesium Citrate in Controlling Hypertension

University of Texas Southwestern Medical Center30 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Hypertension

Interventions

Potassium chloride powderDRUG

Potassium magnesium Citrate (KMgCit)DRUG

Potassium citrate powderDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, United States

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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