Value of Liquid Potassium Magnesium Citrate in Controlling Hypertension
| Status: | Completed |
|---|---|
| Conditions: | High Blood Pressure (Hypertension) |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 4/21/2016 |
| Start Date: | September 2012 |
| End Date: | January 2015 |
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.
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.
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.
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.
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